Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Amylin Pharmaceuticals, LLC.; Eli Lilly and Company; Ministry of Health, China
• Treatments: 2,4-thiazolidinedione; Exenatide; Insulin; Insulin Lispro; Insulin, Globin Zinc; Pioglitazone; Protamines

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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