Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients
- Conditions
- Diabetes Mellitus, Type 2Newly Diagnosed
- Interventions
- Drug: Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R
- Registration Number
- NCT01147627
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.
- Detailed Description
One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. There are trials demonstrated efficacy, safety and tolerability of exenatide. However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
- newly-diagnosed type 2 diabetic patients, drug naïve
- age 30~70 years
- HbA1c 7.0~10.0%
- BMI 20~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
- female patients of reproductive age should practice a reliable method of birth control throughout the study
- acute or severe chronic diabetic complications
- congestive heart failure (NYHA grade Ⅲ~Ⅳ)
- severe gastrointestinal disease
- severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation
- other severe intercurrent illness
- serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
- tested positive for glutamic acid decarboxylase antibody
- use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
- history of pancreatitis
- serum triglyceride ≥ 5.0 mmol/L
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Premixed insulin analog Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R - Exenatide exenatide injection - pioglitazone Pioglitazone -
- Primary Outcome Measures
Name Time Method the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks 48 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (25)
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, China
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
China Medical University
🇨🇳Shenyang, Liaoning, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General 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, China
The Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The first Affiliated Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Qingyuan People's hospital
🇨🇳Qingyuan, Guangdong, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
Affiliated hospital of Guangdong medical college
🇨🇳Zhanjiang, Guangdong, China
The first affiliated hospital of Guangxi Medical College
🇨🇳Nanning, Guangxi, China
The Affiliated Hospital of Guiyang Medical College
🇨🇳Guiyang, Guizhou, China
The 2nd Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, 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
Zhongda Hospital of Southeast University
🇨🇳Nanjing, Jiangsu, 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
Peking University First Hospital
🇨🇳Beijing, Beijing, China