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

Type 2 Diabetes Clinical Trial

— T2DMRS  

Official title:

Effect of Short-term Intensive Insulin Sequential Exenatide Therapy on Beta Cell Function and Glycaemic Control in Patients With Newly Diagnosed Type 2 Diabetes :a Multicenter Prospective Randomized Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02129985
• Other study ID #: HS2014-005
• Status: Recruiting
• Phase: Phase 4
• First received: April 10, 2014
• Last updated: April 30, 2014
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: April 2014
• Source: Huashan Hospital
• Contact: xiaolong zhao, MD.
• Phone: 86-18918067241
• Email: xiaolongzhao[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Exenatide
Exenatide (10 ug/bid for 3 months)
• Metformin
Metformin 850 mg/bid for 3 months

Locations

Country	Name	City	State
China	Xiaolong Zhao	Jingan	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
xiaolong zhao	Fuling Central Hospital of Chongqing City, Pudong Gongli hospital of Shanghai, Second Affiliated Hospital of Soochow University, Shanghai Zhongshan Hospital, Taizhou Hospital, The First Hospital of Guiyang Medical college, The third people's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1C level at every 3 months during the whole study	HbA1C level at every 3 months during the whole study	1 year	No
Other	mean glucose level during the follow without drug intervention	mean glucose level during the follow without drug intervention	1 year	Yes
Other	number of hypoglycemia and severe hypoglycemia during the study	number of hypoglycemia and severe hypoglycemia during the study	up to 1 year	Yes
Primary	time to glycaemic remission	time of glycaemic remission at 1 year after exenatide sequential therapy followed by a short-term insulin intensive treatment	up to 1 year	No
Primary	remission rate of type 2 diabetes at a year.	remission rate of type 2 diabetes after short-term intensive insulin and exenatide sequencial therapy	up to 1 year	No
Secondary	the beta cell function change	the beta cell function change expressed by the ratio of proinsulin to insulin in fasting state and HOMA beta,the ratio of Glucose change to insulin change between at 30min and 0min time point of OGTT	1 year	No