Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

Xiamen University

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: insulin lispro injection, exenatide injection; Drug: insulin lispro injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01776788

bmd-201207-xm

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

insulin lispro injection, exenatide injection

Experimental group

Treatment:

Drug: insulin lispro injection, exenatide injection

insulin lispro injection

Active Comparator group

Treatment:

Drug: insulin lispro injection