Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients
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
1 other identifier
interventional
416
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Aug 2010
Typical duration for not_applicable diabetes-mellitus-type-2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
August 21, 2013
CompletedAugust 21, 2013
June 1, 2013
2 years
June 18, 2010
June 6, 2013
June 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
48 weeks
Secondary Outcomes (3)
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
48 weeks
β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)
48 weeks
Safety and Tolerability in Different Groups
48 weeks
Study Arms (3)
Exenatide
ACTIVE COMPARATORPremixed insulin analog
ACTIVE COMPARATORpioglitazone
ACTIVE COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Eli Lilly and Companycollaborator
- Amylin Pharmaceuticals, LLC.collaborator
- Ministry of Health, Chinacollaborator
Study Sites (25)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Peking University First Hospital
Beijing, Beijing Municipality, China
The Military General Hospital of Beijing PLA
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Qingyuan People's hospital
Qingyuan, Guangdong, 511500, China
The first Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
Affiliated hospital of Guangdong medical college
Zhanjiang, Guangdong, 524001, China
The first affiliated hospital of Guangxi Medical College
Nanning, Guangxi, 530000, China
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Second Xiangya Hospital of Central-south University
Changsha, Hunan, 410011, China
The Affiliated Hospital of Inner Mangolia Medical College
Hohhot, Inner Mongolia, 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
Nanjing, Jiangsu, China
China Medical University
Shenyang, Liaoning, 110001, China
Xijing Hospital of The Fourth Military Medical University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The open-label design, which could have introduced bias by affecting patients' expectations and adherence to therapy.
Results Point of Contact
- Title
- Dr. Jianping Weng
- Organization
- The Third Affiliated Hospital of Sun Yat-sen University
Study Officials
- STUDY DIRECTOR
Jianping Weng, Doctor
Third Affiliated Hospital, Sun Yat-Sen University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor, vice president, the third affiliated hospital of Sun Yat-sen University
Study Record Dates
First Submitted
June 18, 2010
First Posted
June 22, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2012
Study Completion
December 1, 2012
Last Updated
August 21, 2013
Results First Posted
August 21, 2013
Record last verified: 2013-06