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

NCT01147627 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2013-08-21

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2
  • Newly Diagnosed

Interventions

DRUG

exenatide injection

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.

DRUG

Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R

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.

DRUG

Pioglitazone

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.

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Amylin Pharmaceuticals, LLC.

    collaborator INDUSTRY

  • Ministry of Health, China

    collaborator OTHER_GOV

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jianping Weng, Doctor · Third Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-08-31
Completion
2012-12-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147627 on ClinicalTrials.gov