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

NCT ID: NCT01610154

Last Updated: 2017-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Insulin Secretion Insulin Resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sitagliptin treatment

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

Sitagliptin 100 mg QD for 12 weeks

Interventions

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Sitagliptin

Sitagliptin 100 mg QD for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangwei Li

OTHER

Sponsor Role lead

Responsible Party

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Guangwei Li

director of endocrinology and cardiovascular disease center of Fuwai hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fuwai Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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CIFuwaiHospital-MISP39889

Identifier Type: -

Identifier Source: org_study_id

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