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Clinical Trial Details

Trial ID: L1963
Source ID: NCT01147627
Associated Drug: Exenatide Injection
Title: Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01147627/results
Conditions: Diabetes Mellitus, Type 2|Newly Diagnosed
Interventions: DRUG: exenatide injection|DRUG: Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R|DRUG: Pioglitazone
Outcome Measures: Primary: the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks, 48 weeks | Secondary: Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles, 48 weeks|β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio), 48 weeks|Safety and Tolerability in Different Groups, 48 weeks
Sponsor/Collaborators: Sponsor: Sun Yat-sen University | Collaborators: Eli Lilly and Company|Amylin Pharmaceuticals, LLC.|Ministry of Health, China
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 416
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-08
Completion Date: 2012-12
Results First Posted: 2013-08-21
Last Update Posted: 2013-08-21
Locations: China-Japan Friendship Hospital, Beijing, Beijing, 100029, China|Peking University People's Hospital, Beijing, Beijing, 100044, China|Beijing Hospital, Beijing, Beijing, 100730, China|Chinese PLA General Hospital, Beijing, Beijing, 100853, China|Peking University First Hospital, Beijing, Beijing, China|The Military General Hospital of Beijing PLA, Beijing, Beijing, China|The Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510000, China|The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510630, China|Qingyuan People's hospital, Qingyuan, Guangdong, 511500, China|The first Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, 515041, China|Shenzhen Second People's Hospital, Shenzhen, Guangdong, 518035, China|Affiliated hospital of Guangdong medical college, Zhanjiang, Guangdong, 524001, China|The first affiliated hospital of Guangxi Medical College, Nanning, Guangxi, 530000, China|The Affiliated Hospital of Guiyang Medical College, Guiyang, Guizhou, China|The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China|Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China|Second Xiangya Hospital of Central-south University, Changsha, Hunan, 410011, China|The Affiliated Hospital of Inner Mangolia Medical College, Hohhot, Inner Mongolia, China|Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China|The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China|Zhongda Hospital of Southeast University, Nanjing, Jiangsu, China|China Medical University, Shenyang, Liaoning, 110001, China|Xijing Hospital of The Fourth Military Medical University, Xian, Shaanxi, China|The First Affiliated Hospital of Kunming Medical College, Kunming, Yunnan, China|The First Affiliated Hospital of Chongqing Medical University, Chongqing, China
URL: https://clinicaltrials.gov/show/NCT01147627