Trial Outcomes & Findings for Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans (NCT NCT01600703)

Results Overview

Apolipoprotein B48 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

21 participants

Primary outcome timeframe

10 hours

Results posted on

2017-01-23

Participant Flow

Local newspaper advertisement

21 participants were enrolled in the study, however only 15 were started.

Participant milestones

Participant milestones
Measure	Placebo First, Then Sitagliptin placebo, oral, single dose sitagliptin, 100 mg, oral, single dose	Sitagliptin First, Then Placebo placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
First Intervention STARTED	7	8
First Intervention COMPLETED	7	8
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	7	8
Second Intervention COMPLETED	7	8
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=15 Participants placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
Age, Continuous	42.3 years STANDARD_DEVIATION 2.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment Canada	15 participants n=5 Participants
Body mass index	24.6 kg/m^2 STANDARD_DEVIATION 0.6 • n=5 Participants
Glucose Levels	4.9 mmol/l STANDARD_DEVIATION 0.1 • n=5 Participants
Triglyceride Levels	1.2 mmol/l STANDARD_DEVIATION 0.2 • n=5 Participants

PRIMARY outcome

Timeframe: 10 hours

Apolipoprotein B48 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants placebo, oral, single dose	Sitagliptin n=15 Participants sitagliptin, 100 mg, oral, single dose
Apolipoprotein B48 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)	122.9 ug/kg/day Standard Error 30.4	60.6 ug/kg/day Standard Error 12.2

SECONDARY outcome

Timeframe: 10 hours

Apolipoprotein B100 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants placebo, oral, single dose	Sitagliptin n=15 Participants sitagliptin, 100 mg, oral, single dose
Apolipoprotein B100 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)	17.6 mg/kg/day Standard Error 1.8	20.4 mg/kg/day Standard Error 2.9

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sitagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gary Lewis

University Health Network

Phone: 416-340-4270

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place