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Clinical Trial Details

Trial ID: L4613
Source ID: NCT02897349
Associated Drug: Placebo
Title: Linagliptin Add-on to Insulin Background Therapy
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02897349/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: placebo|DRUG: linagliptin|DRUG: background therapy
Outcome Measures: Primary: Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment, Percentage change from baseline, that is, \[\[(HbA1c after 24 weeks of treatment) - (HbA1c at baseline)\] / (HbA1c at baseline)\] \*100%, where baseline refers to the last observation prior to the start of randomised study drug, including the observation prior to the placebo run-in., Baseline and week 24 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment, Change from baseline in Fasting plasma glucose (FPG) after 24 weeks of treatment., Baseline and week 24|Change From Baseline in 2-hour (2-h) Postprandial Plasma Glucose (PPG) After 24 Weeks of Treatment, Change from baseline in 2-hour (2-h) postprandial plasma glucose (PPG) after 24 weeks of treatment., Baseline and week 24|Percentage of Participants With HbA1c on Treatment <7.0 Percentage (%) After 24 Weeks of Treatment, Percentage of participants with HbA1c on treatment \<7.0 percentage (%) after 24 weeks of treatment. Participants with baseline HbA1c \<7.0% were excluded from the analysis., 24 weeks|Percentage of Participants With HbA1c on Treatment < 6.5% After 24 Weeks of Treatment, Percentage of participants with HbA1c on treatment \< 6.5% after 24 weeks of treatment. Participants with baseline HbA1c \<6.5% were excluded from the analysis., 24 weeks|Percentage of Participants With HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment, Percentage of participants with HbA1c lowering by at least 0.5% after 24 weeks of treatment., 24 weeks|Percentage of Participants With Any Investigator-defined Hypoglycaemic Adverse Event (AE) With Plasma Glucose (PG) ≤70 mg/dL, Incidence of investigator-reported hypoglycaemic events confirmed by a measured blood glucose ≤70 mg/dL (≤3.9 Millimoles Per Litre (mmol/L)). Severe hypoglycaemic AE = hypoglycaemic event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions., 24 weeks|Percentage of Participants With Any Severe Hypoglycaemic AE, Incidence of severe hypoglycaemic events (requiring active assistance by another person, or fatal). Severe hypoglycaemic AE = hypoglycaemic event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions., 24 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 206
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2016-09-30
Completion Date: 2019-01-18
Results First Posted: 2020-01-21
Last Update Posted: 2020-03-25
Locations: China-Japan Friendship Hospital, Beijing, 100029, China|Beijing Tongren Hospital, Beijing, 100730, China|The General Hospital of Chinese People's Armed Police Forces, Beijing, 100854, China|First Hospital of Jilin University, Changchun, 130021, China|No.900 Hospital of PLA Joint Logistics Support Force, Fuzhou, 350025, China|Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510150, China|The Affiliated Hospital of Guizhou Medical University, Guiyang, 550004, China|The Affiliated Hospital of Hangzhou Normal University, Hangzhou, 310015, China|General Hospital of Jinan Military Area, Jinan, 250000, China|Nanjing First Hospital, Nanjing, 210006, China|The affiliated hospital of medicalcollege qingdao university, Qingdao, 266005, China|Centre Hospital of Putuo District, Shanghai, Shanghai, 200062, China|Shanghai Tenth People's Hospital, Shanghai, 200072, China|Yangpu Hospital, Tongji University, Shanghai, 200090, China|Second Hospital Affiliated to Shantou Medical University, Shantou, 515041, China|Shengjing Hospital of China Medical University, Shengyang, 110072, China|Siping Central People's Hospital, Siping, 136000, China|The First Affiliated Hospital of Soochow University, Suzhou, 215006, China|Nankai University Affiliated Hospital, Tianjin, 300000, China|The 2nd Hospital of Tianjin Medical University, Tianjin, 300000, China|Tianjin Medical University General Hospital, Tianjin, 30052, China|Renmin Hospital of Wuhan University, Wuhan, 430060, China|First Affiliated Hospital of Xiamen University, Xiamen, 361003, China|the first people hospital of Yue Yang, Yueyang, 414000, China|Affiliated Hospital of Jiangsu University, Zhenjiang, 212013, China
URL: https://clinicaltrials.gov/show/NCT02897349