Clinical trial NCT01147627: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Newly Diagnosed
Keywords: diabetes mellitus, type 2
newly diagnosed
exenatide
premixed insulin analog
thiazolidinedione
β-cell function
glycemic control
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Amylin Pharmaceuticals, LLC.
name: Ministry of Health, China
First posted: 2010-06-22
Enrollment: 416
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: 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
timeFrame: 48 weeks
measure: β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)
timeFrame: 48 weeks
measure: Safety and Tolerability in Different Groups
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: The Military General Hospital of Beijing PLA
state: Beijing
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Qingyuan
country: China
facility: Qingyuan People's hospital
state: Guangdong
city: Shantou
country: China
facility: The first Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated hospital of Guangdong medical college
state: Guangdong
city: Nanning
country: China
facility: The first affiliated hospital of Guangxi Medical College
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Hospital of Guiyang Medical College
state: Guizhou
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Second Xiangya Hospital of Central-south University
state: Hunan
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mangolia Medical College
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital of Southeast University
state: Jiangsu
city: Shenyang
country: China
facility: China Medical University
state: Liaoning
city: Xian
country: China
facility: Xijing Hospital of The Fourth Military Medical University
state: Shaanxi
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical College
state: Yunnan
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Jianping Weng, Doctor
role: STUDY_DIRECTOR
References: