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

Sun Yat-sen University

Status

Completed

Conditions

Newly Diagnosed

Diabetes Mellitus, Type 2

Treatments

Drug: Pioglitazone

Drug: Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R

Drug: exenatide injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01147627

IIT-201007-WJP

Details and patient eligibility

About

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.

Full 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.

Enrollment

416 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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