Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy

NCT ID: NCT02129985

Last Updated: 2014-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-09-30

Brief Summary

Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.

Detailed Description

The UK Prospective Diabetes Study has shown that β-cell function progressively deteriorates over time in people with type 2 diabetes mellitus,irrespective of lifestyle and existing pharmacological interventions. The progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches.Short-term intensive insulin therapy of newly diagnosed type 2 diabetes has been proved improving beta-cell function and usually leading to a temporary remission time,but the remission rate in a year is only about 50%. The effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis. It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis. Exenatide is an GLP-1 receptor agonist. Exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression. However, no study has evaluated effect of short-term intensive insulin sequential exenatide therapy model on β-cell function and glycemic remission rate in newly diagnosed type 2 diabetic patients. Our hypotheses is whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exenatide

patients were all received a short-term intensive insulin therapy,then randomised to Exenatide group(10 ug two times a day for three months)

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

Exenatide (10 ug/bid for 3 months)

Metformin

patients were all received a short-term intensive insulin therapy,then randomised to metformin group(850mg two times a day for three months)

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Metformin 850 mg/bid for 3 months

Interventions

Exenatide

Exenatide (10 ug/bid for 3 months)

Intervention Type: DRUG

Metformin

Metformin 850 mg/bid for 3 months

Intervention Type: DRUG

Other Intervention Names

GLP-1 receptor agonist; Glucophage

Eligibility Criteria

Inclusion Criteria

• newly diagnosed type 2 diabetes without drug treatment
• 25-70 years old age
• Fasting glucose between 7.0-16.7mmol / L
• BMI at 20 ~ 35 kg/m2 and stable for at least 3 month(weight fluctuations within three months does not exceed 10%)
• females who have no plan of pregnancy during the study

Exclusion Criteria

• acute or chronic complications of diabetes
• myocardial infarction or cerebrovascular events within three months
• serious gastrointestinal diseases
• other serious concomitant diseases
• liver or kidney dysfunction:Transaminase (ALT and AST) greater than 3 times the upper limit of the normal range or creatinine levels greater than 133μmol / L
• GAD antibodies positive
• history of pancreatitis or pancreatic cancer;
• pregnant or breastfeeding women.
• severe hypertension (blood pressure> 180/110mmhg)
• using corticosteroids, immunosuppressants and cytotoxic therapy.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

The third people's Hospital Affiliated to Shanghai Jiao Tong University

UNKNOWN

Sponsor Role: collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

The First Hospital of Guiyang Medical college

UNKNOWN

Sponsor Role: collaborator

Fuling Central Hospital of Chongqing City

OTHER

Sponsor Role: collaborator

Taizhou Hospital

OTHER

Sponsor Role: collaborator

Shanghai Pudong New Area Gongli Hospital

OTHER

Sponsor Role: collaborator

xiaolong zhao

OTHER

Sponsor Role: lead

Responsible Party

xiaolong zhao

Endocrinology department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xiaolong Zhao

Jingan, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiaolong zhao, MD.

Role: CONTACT

xiaolongzhao@163.com

86-18918067241

Facility Contacts

xiaolong zhao, MD.

Role: primary

xiaolongzhao@163.com

86-18918067241

Other Identifiers

HS2014-005

Identifier Type: -

Identifier Source: org_study_id