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

June 11, 2013 updated by: Jianping Weng, Sun Yat-sen University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

416

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General hospital
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, Beijing, China, 100730
        • Beijing Hospital
      • Beijing, Beijing, China
        • Peking University First Hospital
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital
      • Beijing, Beijing, China
        • The Military General Hospital of Beijing PLA
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510000
        • The Second Affiliated Hospital of Sun Yat-sen University
      • Qingyuan, Guangdong, China, 511500
        • Qingyuan People's Hospital
      • Shantou, Guangdong, China, 515041
        • The First Affiliated Hospital of Shantou University Medical College
      • Shenzhen, Guangdong, China, 518035
        • Shenzhen Second People's Hospital
      • Zhanjiang, Guangdong, China, 524001
        • Affiliated Hospital of Guangdong Medical College
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • The first affiliated hospital of Guangxi Medical College
    • Guizhou
      • Guiyang, Guizhou, China
        • The affiliated Hospital of Guiyang Medical College
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The 2nd Affiliated Hospital of Harbin Medical University
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410011
        • Second Xiangya Hospital of Central-south University
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • The Affiliated Hospital of Inner Mangolia Medical College
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Nanjing, Jiangsu, China
        • The First Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, China
        • Zhongda Hospital of Southeast University
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • China Medical University
    • Shaanxi
      • Xian, Shaanxi, China
        • Xijing Hospital of the Fourth Military Medical University
    • Yunnan
      • Kunming, Yunnan, China
        • The First Affiliated Hospital of Kunming Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exenatide
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.
Other Names:
  • Byetta®(Eli Lilly and Company)
Active Comparator: Premixed insulin analog
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.
Other Names:
  • Humalog Mix 25®（Eli Lilly and Company)
Active Comparator: pioglitazone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
48 weeks
β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)
Time Frame: 48 weeks
48 weeks
Safety and Tolerability in Different Groups
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Eli Lilly and Company
Ministry of Health, China
Amylin Pharmaceuticals, LLC.

Investigators

  • Study Director: Jianping Weng, Doctor, Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 18, 2010

First Submitted That Met QC Criteria

June 18, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-201007-WJP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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