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Clinical Trial Details

Trial ID: L4234
Source ID: NCT03344341
Associated Drug: Dapagliflozin
Title: A Phase IV Study in Drug-Naive Patients With T2DM in China
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin|DRUG: Acarbose
Outcome Measures: Primary: Absolute change from baseline in HbA1c at Week 24, Which will be derived using the HbA1c (%) at week 24 minus HbA1c (%) at baseline., At week 24 | Secondary: Percentage of patients at Week 24 with reduction of HbA1c≥0.5%, body weight≥3% and SBP ≥3mmHg from baseline, Which will be derived using the number of patients who have reduction in HbA1c ≥ 5%, and body weight ≥3% and SBP ≥3 mmHg compared to baseline divided by the total number of patients., From baseline to week 24|Percentage of patients achieving HbA1c<7.0%, Which will be derived using the number of patient who have the HbA1c (%) \< 7.0% after 24 weeks treatment divided by the total number of patients., From baseline to week 24|Percentage of patients with reduction of HbA1c≥0.5%, Which will be derived using the number of patients who have reduction in HbA1c≥0.5% after 24 weeks compared to baseline divided by the total number of patients., From baseline to week 24|Absolute change from baseline in fasting plasma glucose (FPG), Which will be derived using the value of fasting plasma glucose (FPG) at post-baseline visits minus the value at baseline, From baseline to week 24|Absolute change from baseline in 2h postprandial glucose (PPG), Which will be derived using the value of 2h postprandial glucose (PPG) at the post-baseline visits minus the value at baseline, From baseline to week 24|Absolute change from baseline in body weight, Which will be derived using the value of the body weight at the post-baseline visits minus the value at baseline, From baseline to week 24|Percentage of patients with reduction of body weight ≥3%, Which will be derived using the number of patients who have reduction in body weight≥3% after 24 weeks compared to baseline divided by the total number of patients., From baseline to week 24|Absolute change from baseline in systolic blood pressure (SBP), Which will be derived using the value of the systolic blood pressure at the post-baseline visits minus the value at baseline, From baseline to week 24|Percentage of patients with reduction of SBP ≥3 mmHg, Which will be derived using the number of patients who have reduction in SBP ≥3 mmHg after 24 weeks compared to baseline divided by the total number of patients., From baseline to week 24 | Other: Homeostasis model assessment-β, Which will be used to evaluate the beta cell function., From baseline to week 24|HOMA-IR, Which will be used to evaluate the insulin sensitivity, From baseline to week 24|The difference of the number between tablets taken and tablets prescribed, Which will be derived using the number of tablets dispensed minus the number of tablets returned, From baseline to week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 304
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-12-15
Completion Date: 2019-05-24
Results First Posted:
Last Update Posted: 2021-12-07
Locations: Research Site, Beijing, 100020, China|Research Site, Beijing, 100730, China|Research Site, Changsha, 410013, China|Research Site, Chengdu, 610041, China|Research Site, Chongqing, 400016, China|Research Site, Guangzhou, 510280, China|Research Site, Hangzhou, 310014, China|Research Site, Hangzhou, 310016, China|Research Site, Hefei, 230022, China|Research Site, Jinan, 250012, China|Research Site, Nanjing, 2100008, China|Research Site, Qingdao, 266003, China|Research Site, Qingdao, China|Research Site, Shanghai, 200233, China|Research Site, Shanghai, CN-200120, China|Research Site, Shenyang, 100003, China|Research Site, Suzhou, 215004, China|Research Site, Tianjin, CN-300070, China|Research Site, Xi'an, 710061, China|Research Site, Yinchuan, 750004, China
URL: https://clinicaltrials.gov/show/NCT03344341