CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 416 enrolled
Drug / intervention
exenatide injection +2 moredrug
Likely dose
exenatide injection 5 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01147627
NCT01147627N/ACompleted
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Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial

Sun Yat-sen University·interventional·Posted Jun 22, 2010·Updated Aug 21, 2013

In Brief

A clinical study evaluating exenatide injection, Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R, and 1 other intervention for Diabetes Mellitus, Type 2 and Newly Diagnosed. Completed, enrolled 416 participants across 25 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Newly Diagnosed
CountriesChina
CollaboratorsEli Lilly and Company, Amylin Pharmaceuticals, LLC., Ministry of Health, China

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.0 years ago

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.