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

Primary Purpose

Diabetes Mellitus, Type 2, Newly Diagnosed

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
exenatide injection
Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R
Pioglitazone
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes mellitus, type 2, newly diagnosed, exenatide, premixed insulin analog, thiazolidinedione, β-cell function, glycemic control

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China-Japan Friendship Hospital
  • Peking University People's Hospital
  • Beijing Hospital
  • Chinese PLA General Hospital
  • Peking University First Hospital
  • The Military General Hospital of Beijing PLA
  • The Second Affiliated Hospital of Sun Yat-sen University
  • The Third Affiliated Hospital of Sun Yat-sen University
  • Qingyuan People's hospital
  • The first Affiliated Hospital of Shantou University Medical College
  • Shenzhen Second People's Hospital
  • Affiliated hospital of Guangdong medical college
  • The first affiliated hospital of Guangxi Medical College
  • The Affiliated Hospital of Guiyang Medical College
  • The 2nd Affiliated Hospital of Harbin Medical University
  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  • Second Xiangya Hospital of Central-south University
  • The Affiliated Hospital of Inner Mangolia Medical College
  • Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of Nanjing Medical University
  • Zhongda Hospital of Southeast University
  • China Medical University
  • Xijing Hospital of The Fourth Military Medical University
  • The First Affiliated Hospital of Kunming Medical College
  • The First Affiliated Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exenatide

Premixed insulin analog

pioglitazone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2010
Last Updated
June 11, 2013
Sponsor
Sun Yat-sen University
Collaborators
Eli Lilly and Company, Amylin Pharmaceuticals, LLC., Ministry of Health, China
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1. Study Identification

Unique Protocol Identification Number
NCT01147627
Brief Title
Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Eli Lilly and Company, Amylin Pharmaceuticals, LLC., Ministry of Health, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Newly Diagnosed
Keywords
diabetes mellitus, type 2, newly diagnosed, exenatide, premixed insulin analog, thiazolidinedione, β-cell function, glycemic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide
Arm Type
Active Comparator
Arm Title
Premixed insulin analog
Arm Type
Active Comparator
Arm Title
pioglitazone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
exenatide injection
Other Intervention Name(s)
Byetta®(Eli Lilly and Company)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R
Other Intervention Name(s)
Humalog Mix 25®（Eli Lilly and Company)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
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
Title
β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)
Time Frame
48 weeks
Title
Safety and Tolerability in Different Groups
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Weng, Doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Military General Hospital of Beijing PLA
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Qingyuan People's hospital
City
Qingyuan
State/Province
Guangdong
ZIP/Postal Code
511500
Country
China
Facility Name
The first Affiliated Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Name
Affiliated hospital of Guangdong medical college
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524001
Country
China
Facility Name
The first affiliated hospital of Guangxi Medical College
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Facility Name
The Affiliated Hospital of Guiyang Medical College
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
The 2nd Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Second Xiangya Hospital of Central-south University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
The Affiliated Hospital of Inner Mangolia Medical College
City
Hohhot
State/Province
Inner Mongolia
Country
China
Facility Name
Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Zhongda Hospital of Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Xijing Hospital of The Fourth Military Medical University
City
Xian
State/Province
Shaanxi
Country
China
Facility Name
The First Affiliated Hospital of Kunming Medical College
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China

12. IPD Sharing Statement

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

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