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

Sun Yat-sen University416 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

416

Conditions

Diabetes Mellitus, Type 2 Newly Diagnosed

Interventions

exenatide injectionDRUG

Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter.

Mixed Protamine Zinc Recombinant Human Insulin Lispro 25RDRUG

Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner.

PioglitazoneDRUG

Patients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (25)

Outcomes

Primary Outcomes

the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks

Time frame: 48 weeks

Secondary Outcomes

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

Time frame: 48 weeks

β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)

Time frame: 48 weeks

Safety and Tolerability in Different Groups

Time frame: 48 weeks

Data from ClinicalTrials.gov

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China-Japan Friendship Hospital