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

NCT01147627 · Completed

Last updated 2026-05-28

This clinical trial compares how different treatments affect blood sugar control and insulin-producing cells in people who were recently diagnosed with type 2 diabetes over a 48-week period.

Status Completed The study has finished.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 416 people

Who can join Ages 30–70 · all sexes

Timeline Started 2010-08 · est. completion 2012-12

Where 25 sites · China

What this study is testing ClinicalTrials.gov NCT01147627 ↗

Description as written by the study sponsor.

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.

Treatments tested

exenatide injection also known as Byetta®(Eli Lilly and Company) Drug

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 25R also known as Humalog Mix 25®（Eli Lilly and Company) Drug

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.
Pioglitazone Drug

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.

Main thing measured	the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
Sponsor	Sun Yat-sen University
Conditions studied	Diabetes Mellitus, Type 2, Newly Diagnosed
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01147627 ↗