Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics

Phase 4

Completed

• Conditions: Insulin Secretion; Insulin Resistance
• Interventions: Drug: Sitagliptin

• Registration Number: NCT01610154
• Lead Sponsor: Guangwei Li

Brief Summary

1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic.

2. There are different effects of Sitagliptin therapy on blood glucose regulation, pancreatic alpha \& beta cell function are different in lean (BMI\<25) and overweight (BMI\>25) Chinese type 2 diabetics.

3. The purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in Chinese type 2 diabetics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-01
• Study Start: 2012-10
• Primary Completion: 2014-08
• Study Completion: 2015-06
• Results First Submitted: 2016-11-27
• Results First Submitted QC: 2017-02-16
• Status Verified: 2017-04
• Results First Posted: 2017-04-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Age: 25~60 years
2. Duration of disease < 3 years,no drug treatment for diabetes
3. Newly diagnosed type 2 diabetic patients (fasting plasma glucose > 7.0mmol/L or/and 2h postprandial blood glucose>11.1mmol/L WHO 1999)
4. Fasting plasma glucose < 10 mmol/L

Exclusion Criteria

1. Type 1 diabetes
2. DKA, infection and other stress status
3. Autoimmune disease
4. Hepatic and renal diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sitagliptin treatment	Sitagliptin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c)	Baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG)	Baseline to 12 weeks
Change From Baseline in Postprandial Plasma Glucose (PPG)	Baseline to 12 weeks
Change From Baseline in Insulin Sensitivity	Baseline to 12 weeks	The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Change From Baseline in Insulin Sensitivity in Patients With Different BMI	Baseline to 12 weeks	The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Change From Baseline in Pancreatic β Cell Function	Baseline to 12 weeks	The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI	Baseline to 12 weeks	The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Change From Baseline in Pancreatic α Cell Function	Baseline to 12 weeks	The glucagon-AUC was adopted to show pancreatic α cell function.
Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI	Baseline to 12 weeks	The glucagon-AUC was adopted to show pancreatic α cell function.

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, China