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Clinical Trial Details

Trial ID: L5691
Source ID: NCT04017832
Associated Drug: Oral Semaglutide
Title: A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes
Acronym: PIONEER 12
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04017832/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Oral semaglutide|DRUG: Sitagliptin|DRUG: Placebo (oral semaglutide)|DRUG: Placebo (sitagliptin)
Outcome Measures: Primary: Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%), Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication., From baseline to week 26 | Secondary: Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG), Change in fasting plasma glucose (FPG) from baseline to week 26 in millimole per liter (mmol/l) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile, Change from baseline in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals), Change from baseline in 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no), Number of participants who achieved HbA1c \<7.0% (53 mmol/mol) (ADA target) is presented in category "Yes" and participants who could not achieve HbA1C \<7.0 (53 mmol/mol) (ADA target) is presented in category "No". The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., At week 26|Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no), Number of participants who achieved HbA1c equal to or below 6.5 percent (48 mmol/mol) (AACE target) (yes/no) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., At week 26|Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no), Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., At week 26|Time to Rescue Medication, Time to rescue medication is presented as the number of participants who had taken rescue medication anytime from baseline to week 31. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 31|Change From Baseline to Week 26 in Body Weight (Kilogram [kg]), Change in body weight from baseline to week 26 in kg is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Percentage Change From Baseline to Week 26 in Body Weight, Percentage change from baseline to week 26 in body weight is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Body Mass Index (BMI), Change from baseline in BMI is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Waist Circumference, Change from baseline in waist circumference is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline), Change from baseline in total cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline), Change from baseline in LDL cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline), Change from baseline in VLDL cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline), Change from baseline in HDL Cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline), Change from baseline in triglycerides (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline), Change from baseline in free fatty acids (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey, SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). A positive change score indicates an improvement since baseline. Outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to end date which was first date of any of following: the last dose of trial product plus 3 days or initiation of rescue medication., From baseline to week 26|Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no), Number of participants who achieved body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above., At week 26|Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no), Number of participants who achieved body weight loss equal to or above 5 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above., At week 26|Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no), Number of participants who achieved body weight loss equal to or above 10 percent (yes/no). The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above., At week 26|Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no), Number of participants who achieved HbA1c \< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above., At week 26|Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no), Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) and body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above., At week 26|Number of Treatment-emergent Adverse Events During Exposure to Trial Product, An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs with onset during the on-treatment period correspond to treatment-emergent AEs (TEAEs). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 31|Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product, Number of treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 31|Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils, Change from baseline in hematology parameters such as basophils, eosinophils, lymphocytes, monocytes, and neutrophils were reported. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline), Change from baseline in Haematocrit at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline), Change from baseline in Haemoglobin at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline), Change from baseline in Leucocytes at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline), Change from baseline in thrombocytes at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline), Change from baseline in calcium (total) (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline), Change from baseline in potassium (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline), Change from baseline in sodium (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline), Change from baseline in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline), Change from baseline in Albumin (measured in grams per deciliter \[g/dL\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline), Change from baseline in calcitonin (measured in picograms per milliliter \[pg/ml\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Vital Signs: Pulse Rate, Change from baseline in pulse rate is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure, Change from baseline in systolic blood pressure is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure, Change from baseline in diastolic blood pressure is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Change From Baseline to Week 26 in Electrocardiogram (ECG) Category, Change from baseline in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Physical Examination Category, The physical examination values for different body systems at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The physical examination are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., Baseline and week 26|Change From Baseline to Week 26 in Eye Examination Category, The eye examination category at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 26|Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product, Number of participants with treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period., From baseline to week 31
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1441
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-07-29
Completion Date: 2021-10-27
Results First Posted: 2023-09-29
Last Update Posted: 2024-10-01
Locations: Maison des diabétiques El Harrach, Algiers, 16000, Algeria|Department of internal medicine hospital (CHU) of BIRTRARIA, Algiers, 16003, Algeria|Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda., Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|CPQuali Pesquisa Clínica Ltda, São Paulo, Sao Paulo, 01228-000, Brazil|CPCLIN - Centro de Pesquisas Clínicas, São Paulo, Sao Paulo, 01228-200, Brazil|Anhui Provincial Hospital, Hefei, Anhui, 230001, China|The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230061, China|Peking University People's Hospital, Beijing, Beijing, 100044, China|Peking University Shougang Hospital, Beijing, Beijing, 100144, China|Beijing Pinggu Hospital, Beijing, Beijing, 101200, China|Second Affliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400010, China|900th Hospital of Joint Logistics Support Force, Fuzhou, Fujian, 350025, China|The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, 362000, China|Shunde Hospital of Southern Medical University, Foshan, Guangdong, 528399, China|Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy, Guangzhou, Guangdong, 510120, China|Guangzhou Panyu Central Hospital, Guangzhou, Guangdong, 511400, China|Huizhou Central People's Hospital, Huizhou, Guangdong, 516001, China|The 2nd Affiliated Hospital of Shantou Uni Medical College, Shantou, Guangdong, 515065, China|Cangzhou People's Hospital, Cangzhou, Hebei, 061000, China|Harrison International Peace Hospital, Hengshui, Hebei, 053000, China|The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050000, China|Huaihe Hospital of Henan University, Kaifeng, Henan, 475000, China|The First Affiliated Hospital of Henan university of Science, Luoyang, Henan, 471003, China|Zhengzhou First People's Hospital, Zhengzhou, Henan, 450004, China|Taihe Hospital, Shiyan, Hubei, 442008, China|Wuhan Puai Hosptial, Wuhan, Hubei, 430034, China|Changsha Central Hospital, Changsha, Hunan, 410018, China|Chenzhou No.1 People's Hospital, Chenzhou, Hunan, 423000, China|The First Affiliated Hospital Of University Of South China, Hengyang, Hunan, 421001, China|Zhuzhou Central Hospital, Zhuzhou, Hunan, 412007, China|Changzhou No.2 People's Hospital, Yanghu Branch, Changzhou, Jiangsu, 213003, China|The First People's Hospital of Changzhou, Changzhou, Jiangsu, 213003, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China|Nanjing Jiangning Hospital, Nanjing, Jiangsu, 211106, China|Sir Run Run Hospital Nanjing Medical University, Nanjing, Jiangsu, 211166, China|The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215004, China|The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China|Wuxi People's Hospital, Wuxi, Jiangsu, 214023, China|The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221002, China|The Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212001, China|Pingxiang People's Hospital, Pingxiang, Jiangxi, 337055, China|Jilin Province People's Hospital, Changchun, Jilin, 130021, China|China-Japan Union Hospital of Jilin University, Changchun, Jilin, 130033, China|The Second Hospital of Jilin University, Changchun, Jilin, 130041, China|General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China|Qinghai Provincial People's Hospital, Xining, Qinghai, 810007, China|The second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710004, China|Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, 250013, China|The Affiliated Hospital of Qingdao Medical College, Qingdao, Shandong, 266003, China|Weifang People's Hospital, Weifang, Shandong, 261041, China|Shanghai Pudong New Area People's Hospital, Pudong New District, Shanghai, 201200, China|Shanghai Huashan Hospital, Affiliated to Fudan University, Shanghai, Shanghai, 200040, China|Tongji Hospital of Tongji university, Shanghai, Shanghai, 200065, China|Shanghai Tenth People's Hsopital, Tongji University, Shanghai, Shanghai, 200072, China|Dongfang Hospital Affiliated to Shanghai Tongji University, Shanghai, Shanghai, 200120, China|The Fifth People's Hospital of Shanghai, Shanghai, Shanghai, 200240, China|Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine, Shanghai, Shanghai, 200336, China|General Hospital of Tianjin Medical University, Tianjin, Tianjin, 300052, China|The Second Hospital of Tianjin Medical University, Tianjin, Tianjin, 300211, China|First Affiated Hospital of Kunming Medical University, Kunming, Yunnan, 650032, China|The First People's Hospital of Yunnan Province, Kunming, Yunnan, 650032, China|The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, 650101, China|The 2nd Affi Hosp of Zhejiang Univer School of Medicine, Hangzhou, Zhejiang, 310009, China|The Third Xiangya Hospital of Central South University, Changsha, 410013, China|Nemocnice milosrdnych bratri, Brno, 63900, Czechia|DIAMIN, Chrudim, 537 01, Czechia|Interna a diabetologie MUDr. Vodickova, Liberec, 46001, Czechia|MUDr. Michala Pelikanova, Praha 4, 140 00, Czechia|CCR Prague, Praha, 130 00, Czechia|Prince of Wales Hospital, Shatin, New Territories, Hong Kong|SC Grand Med SRL, Oradea, Bihor, 410025, Romania|S.C. Endodigest S.R.L., Oradea, Bihor, 410151, Romania|SC Centru Medical Dr. Negrisanu SRL, Timisoara, Timis, 300456, Romania|SC Nutrilife SRL, Bucharest, 13682, Romania|Clinic of Diabetes Constanta, Constanta, 900591, Romania|Clinical County Emergency Hosp, Oradea, 410169, Romania|Clinical Hospital Centre Dragisa Misovic, Belgrade, 11000, Serbia|Endocrinology, Diabetes and Metabolism Diseases Clinic, Belgrade, 11000, Serbia|Clinical Hospital Centre Zemun, Belgrade, 11080, Serbia|GCT, Arcadia, Gauteng, 0083, South Africa|Dr R Dulabh, Johannesburg, Gauteng, 1812, South Africa|Newtown Clinical Research, Johannesburg, Gauteng, 2001, South Africa|WITS Clinical Research, Johannesburg, Gauteng, 2193, South Africa|Clinresco Centres (Pty) Ltd, Kempton Park, Gauteng, 1619, South Africa|Setshaba Research Centre, Soshanguve, Gauteng, 0152, South Africa|Armansis Medical Centre, Brits, North West, 0250, South Africa|Cape Town Medical Research Centre, Kuilsriver, Western Cape, 7580, South Africa|Paarl Reserch Centre, Paarl, Western Cape, 7646, South Africa|Union Hospital, Alberton, 1449, South Africa|National Taiwan University Hospital, Taipei, 100, Taiwan|Taipei Veterans General Hospital, Taipei, 112, Taiwan|Tri-Service General Hospital, Taipei, 114, Taiwan|Chang Gung Medical Foundation - Linko Branch, Taoyuan city, 333, Taiwan
URL: https://clinicaltrials.gov/show/NCT04017832