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
Sponsor study identifier
interventional
416
1 country
25
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)Study Completion
December 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 18, 2010
Actual (reported)June 22, 2010
Actual (reported)August 2010
Date type not reportedThis date has not been verified as actual or estimated.
August 2012
Actual (reported)December 2012
Actual (reported)August 21, 2013
Actual (reported)the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
48 weeks
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
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.
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
The open-label design, which could have introduced bias by affecting patients' expectations and adherence to therapy.
Jianping Weng, Doctor
Third Affiliated Hospital, Sun Yat-Sen University
416 participants (actual enrollment reported by the registry).
First Submitted
June 18, 2010
First Posted
June 22, 2010
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Tolerability in Different Groups
48 weeks
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Primary Completion
August 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
August 21, 2013
Results First Posted
August 21, 2013
Record last verified: 2013-06
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