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

April 5, 2017 updated by: Guangwei Li
  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sitagliptin treatment
Drug: Sitagliptin
Sitagliptin 100 mg QD for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangwei Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIFuwaiHospital-MISP39889

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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