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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147627
• Other study ID #: IIT-201007-WJP
• Status: Completed
• Phase: N/A
• First received: June 18, 2010
• Last updated: June 11, 2013
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 ?~?)

• 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Newly Diagnosed

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The Military General Hospital of Beijing PLA	Beijing	Beijing
China	Second Xiangya Hospital of Central-south University	Changsha	Hunan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	The Second Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guiyang Medical College	Guiyang	Guizhou
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Affiliated Hospital of Inner Mangolia Medical College	Hohhot	Inner Mongolia
China	The First Affiliated Hospital of Kunming Medical College	Kunming	Yunnan
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	The first affiliated hospital of Guangxi Medical College	Nanning	Guangxi
China	Qingyuan People's hospital	Qingyuan	Guangdong
China	The first Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	China Medical University	Shenyang	Liaoning
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Xijing Hospital of The Fourth Military Medical University	Xian	Shaanxi
China	Affiliated hospital of Guangdong medical college	Zhanjiang	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Amylin Pharmaceuticals, LLC., Eli Lilly and Company, Ministry of Health, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks		48 weeks	No
Secondary	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	No
Secondary	ß-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)		48 weeks	No
Secondary	Safety and Tolerability in Different Groups		48 weeks	Yes