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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01610154

Enrollment

Registered

2012-06-01

Start date

2012-10-31

Completion date

2015-06-30

Last updated

2017-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Insulin Secretion

Keywords

glucagon, dipeptidyl peptidase-4 inhibitor

Brief summary

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.

Interventions

DRUGSitagliptin

Sitagliptin 100 mg QD for 12 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Change From Baseline in Hemoglobin A1c (HbA1c)	Baseline to 12 weeks

Secondary

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

Countries

China

Participant flow

Recruitment details

Sitagliptin 100 mg QD for 12 weeks and followed-up every 4 weeks

Participants by arm

Arm	Count
Sitagliptin Treatment Sitagliptin 100 mg QD for 12 weeks	84
Total	84

Baseline characteristics

Characteristic	Sitagliptin Treatment
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	84 Participants
Age, Continuous	48.8 years STANDARD_DEVIATION 12.2
Body Mass Index (BMI)	25.8 kg/m2 STANDARD_DEVIATION 3.41
Region of Enrollment China	84 participants
Sex: Female, Male Female	37 Participants
Sex: Female, Male Male	47 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	8 / 84
serious Total, serious adverse events	0 / 84