Status:
COMPLETED
Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Eli Lilly and Company
Amylin Pharmaceuticals, LLC.
Conditions:
Diabetes Mellitus, Type 2
Newly Diagnosed
Eligibility:
All Genders
30-70 years
Phase:
NA
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 diagno...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT01147627
Start Date
August 1 2010
End Date
December 1 2012
Last Update
August 21 2013
Active Locations (25)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
3
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
4
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853