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

NCT01610154 | Completed Phase 4 Results DMC

• 1 other identifier: CIFuwaiHospital-MISP39889
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insulin Secretion; Insulin Resistance

Keywords

glucagon; dipeptidyl peptidase-4 inhibitor

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c)

  Baseline to 12 weeks

Secondary Outcomes (8)

• 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

• Change From Baseline in Insulin Sensitivity in Patients With Different BMI

  Baseline to 12 weeks

• Change From Baseline in Pancreatic β Cell Function

  Baseline to 12 weeks

Study Arms (1)

Sitagliptin treatment

EXPERIMENTAL

Drug: Sitagliptin

Interventions

Sitagliptin DRUG

Sitagliptin 100 mg QD for 12 weeks

Sitagliptin treatment

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Type 1 diabetes
• DKA, infection and other stress status
• Autoimmune disease
• Hepatic and renal diseases

Sponsors & Collaborators

• Guangwei Li: lead

Study Sites (1)

Fuwai Hospital

Beijing, China

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Dr. Hui Wang
• Organization: Fuwai Hospital

wh_endo@163.com

86-010-88396587

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of endocrinology and cardiovascular disease center of Fuwai hospital

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: June 1, 2015
• Last Updated: May 11, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-04

Locations

CN (1)