Trial Outcomes & Findings for 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 NCT01610154)

NCT ID: NCT01610154

Last Updated: 2017-05-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 85 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2017-05-11

Participant Flow

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

Participant milestones

Measure	Sitagliptin Treatment Sitagliptin 100 mg QD for 12 weeks
Overall Study STARTED	85
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sitagliptin Treatment n=84 Participants Sitagliptin 100 mg QD for 12 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48.8 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Region of Enrollment China	84 participants n=5 Participants
Body Mass Index (BMI)	25.8 kg/m2 STANDARD_DEVIATION 3.41 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Outcome measures

Measure	Sitagliptin n=84 Participants Sitagliptin 100 mg QD	Obese Group BMI≥25 kg/m2
Change From Baseline in Hemoglobin A1c (HbA1c)	-1.08 percentage Standard Deviation 0.13	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Outcome measures

Measure	Sitagliptin n=84 Participants Sitagliptin 100 mg QD	Obese Group BMI≥25 kg/m2
Change From Baseline in Fasting Plasma Glucose (FPG)	-1.99 mmol/L Standard Deviation 0.18	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Outcome measures

Measure	Sitagliptin n=84 Participants Sitagliptin 100 mg QD	Obese Group BMI≥25 kg/m2
Change From Baseline in Postprandial Plasma Glucose (PPG)	-4.69 mmol/L Standard Deviation 0.41	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.

Outcome measures

Measure	Sitagliptin n=84 Participants Sitagliptin 100 mg QD	Obese Group BMI≥25 kg/m2
Change From Baseline in Insulin Sensitivity	0.64 mg/kg/min Interval 0.27 to 1.58	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.

Outcome measures

Measure	Sitagliptin n=34 Participants Sitagliptin 100 mg QD	Obese Group n=50 Participants BMI≥25 kg/m2
Change From Baseline in Insulin Sensitivity in Patients With Different BMI	0.42 mg/kg/min Interval 0.14 to 1.25	0.72 mg/kg/min Interval 0.32 to 1.93

SECONDARY outcome

Timeframe: Baseline to 12 weeks

The early phase insulin response (△I30/△G30) was adopted to determine β cell function.

Outcome measures

Measure	Sitagliptin n=84 Participants Sitagliptin 100 mg QD	Obese Group BMI≥25 kg/m2
Change From Baseline in Pancreatic β Cell Function	2.53 μu/ml/mmol Interval 0.78 to 5.64	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

The early phase insulin response (△I30/△G30) was adopted to determine β cell function.

Outcome measures

Measure	Sitagliptin n=34 Participants Sitagliptin 100 mg QD	Obese Group n=50 Participants BMI≥25 kg/m2
Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI	2.30 μu/ml/mmol Interval 0.96 to 4.65	2.85 μu/ml/mmol Interval 0.81 to 6.47

SECONDARY outcome

Timeframe: Baseline to 12 weeks

The glucagon-AUC was adopted to show pancreatic α cell function.

Outcome measures

Measure	Sitagliptin n=84 Participants Sitagliptin 100 mg QD	Obese Group BMI≥25 kg/m2
Change From Baseline in Pancreatic α Cell Function	-27.8 min∙pg/ml Standard Deviation 32.3	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

The glucagon-AUC was adopted to show pancreatic α cell function.

Outcome measures

Measure	Sitagliptin n=34 Participants Sitagliptin 100 mg QD	Obese Group n=50 Participants BMI≥25 kg/m2
Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI	13.6 min∙pg/ml Standard Deviation 87.4	-54.0 min∙pg/ml Standard Deviation 307.4

Adverse Events

Sitagliptin Treatment

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sitagliptin Treatment n=84 participants at risk Sitagliptin 100 mg QD
Metabolism and nutrition disorders Hypoglycemia ( symptom only)	6.0% 5/84 • Number of events 5
Infections and infestations Upper respiratory infection	1.2% 1/84 • Number of events 1
Infections and infestations Nasopharyngitis	2.4% 2/84 • Number of events 2

Additional Information

Dr. Hui Wang

Fuwai Hospital

Phone: 86-010-88396587

Email: wh_endo@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place