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Completed

NCT Number: NCT01610154

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

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.

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Key information

Conditions

Insulin Secretion Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fuwai Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin

Drug

Sitagliptin 100 mg QD for 12 weeks

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG)

    Time frame: Baseline to 12 weeks

  2. Change From Baseline in Postprandial Plasma Glucose (PPG)

    Time frame: Baseline to 12 weeks

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Guangwei Li

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jun 1, 2012
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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