Clinical trial NCT01776788: Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients
Official title: Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy on β-cell Function and Glycemic Remission Rate in Newly Diagnosed Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 156
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 randomized, controlled trial is to investigate and evaluate the effects of short-term continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

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 will improve beta-cell function and usually leading to a temporary remission time. 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 synthetic exendin-4, 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. This current study is thus designed to evaluate effect of short-term intensive insulin sequential exenatide therapy model on β-cell function , glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

Eligibility criteria: Inclusion Criteria:

1. newly-diagnosed type 2 diabetic patients, drug naïve
2. age 30\~70 years
3. FPG 7.0\~16.7mmol/L
4. BMI 20\~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
5. female patients of reproductive age should practice a reliable method of birth control throughout the study

Exclusion Criteria:

1. acute or severe chronic diabetic complications
2. Recently suffered from MI or CVA.
3. severe gastrointestinal disease
4. other severe intercurrent illness
5. serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
6. tested positive for glutamic acid decarboxylase antibody
7. use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
8. history of pancreatitis
9. Pregnant or lactation women.

Primary outcomes:
measure: the glycemic remission rate in different groups
timeFrame: one year
Secondary outcomes:
measure: the improvement of β-cell function in different groups.
timeFrame: one year
measure: the time of glycemic remission in different groups
timeFrame: one year
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The first afilliated hospital of Xiamen university
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University, China
name: Xue-jun Li, MD,PhD
role: STUDY_DIRECTOR
References: