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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

Primary Purpose

Insulin Secretion, Insulin Resistance

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sitagliptin
Sponsored by
Guangwei Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Secretion focused on measuring glucagon, dipeptidyl peptidase-4 inhibitor

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fuwai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sitagliptin treatment

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose (FPG)
Change From Baseline in Postprandial Plasma Glucose (PPG)
Change From Baseline in Insulin Sensitivity
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
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
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
The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Change From Baseline in Pancreatic α Cell Function
The glucagon-AUC was adopted to show pancreatic α cell function.
Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI
The glucagon-AUC was adopted to show pancreatic α cell function.

Full Information

First Posted
May 30, 2012
Last Updated
April 5, 2017
Sponsor
Guangwei Li
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1. Study Identification

Unique Protocol Identification Number
NCT01610154
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guangwei Li

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic. 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. The purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in Chinese type 2 diabetics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Secretion, Insulin Resistance
Keywords
glucagon, dipeptidyl peptidase-4 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
Sitagliptin 100 mg QD for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame
Baseline to 12 weeks
Title
Change From Baseline in Postprandial Plasma Glucose (PPG)
Time Frame
Baseline to 12 weeks
Title
Change From Baseline in Insulin Sensitivity
Description
The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Time Frame
Baseline to 12 weeks
Title
Change From Baseline in Insulin Sensitivity in Patients With Different BMI
Description
The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Time Frame
Baseline to 12 weeks
Title
Change From Baseline in Pancreatic β Cell Function
Description
The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Time Frame
Baseline to 12 weeks
Title
Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI
Description
The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Time Frame
Baseline to 12 weeks
Title
Change From Baseline in Pancreatic α Cell Function
Description
The glucagon-AUC was adopted to show pancreatic α cell function.
Time Frame
Baseline to 12 weeks
Title
Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI
Description
The glucagon-AUC was adopted to show pancreatic α cell function.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 25~60 years Duration of disease < 3 years,no drug treatment for diabetes Newly diagnosed type 2 diabetic patients (fasting plasma glucose > 7.0mmol/L or/and 2h postprandial blood glucose>11.1mmol/L WHO 1999) Fasting plasma glucose < 10 mmol/L Exclusion Criteria: Type 1 diabetes DKA, infection and other stress status Autoimmune disease Hepatic and renal diseases
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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