Trial Outcomes & Findings for Sitagliptin and Kinetics of Triglyceride-rich Lipoproteins Apolipoprotein B48 and B100 in Patients With Type 2 Diabetes (NCT NCT01334229)

NCT ID: NCT01334229

Last Updated: 2016-04-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 22 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2016-04-04

Participant Flow

Participant milestones

Measure	Sitagliptin Then Placebo First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Placebo for 6 weeks	Placebo First Then Sitagliptin First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sitagliptin and Kinetics of Triglyceride-rich Lipoproteins Apolipoprotein B48 and B100 in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Sitagliptin First Then Placebo n=11 Participants First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Pacebo for 6 weeks	Placebo First Then Sitagliptin n=11 Participants First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks	Total n=22 Participants Total of all reporting groups
Age, Continuous	57.5 years STANDARD_DEVIATION 4.6 • n=5 Participants	59 years STANDARD_DEVIATION 2.9 • n=7 Participants	58.2 years STANDARD_DEVIATION 3.8 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	Sitagliptin n=22 Participants Sitagliptin 100 mg/d for 6 weeks Sitagliptin: Sitagliptin 100 mg/d for 6 weeks	Placebo n=22 Participants Placebo for 6 weeks Placebo: Placebo for 6 weeks
Measurement of Apolipoprotein B48 and Apolipoprotein B100 Production Rates With Stable Isotope During Postprandial Period apolipoprotein B48 production rate	2.1 mg/kg/day Standard Deviation 0.7	2.5 mg/kg/day Standard Deviation 1.2
Measurement of Apolipoprotein B48 and Apolipoprotein B100 Production Rates With Stable Isotope During Postprandial Period apolipoprotein B100 production rate	27.5 mg/kg/day Standard Deviation 8.4	30.3 mg/kg/day Standard Deviation 11.3

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	Sitagliptin n=22 Participants Sitagliptin 100 mg/d for 6 weeks Sitagliptin: Sitagliptin 100 mg/d for 6 weeks	Placebo n=22 Participants Placebo for 6 weeks Placebo: Placebo for 6 weeks
Measurement of Glucagon-like Peptide-1 by ELISA	5.6 pmol/L Standard Deviation 6.8	3.1 pmol/L Standard Deviation 5.8

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	Sitagliptin n=22 Participants Sitagliptin 100 mg/d for 6 weeks Sitagliptin: Sitagliptin 100 mg/d for 6 weeks	Placebo n=22 Participants Placebo for 6 weeks Placebo: Placebo for 6 weeks
Measurement of Glucose	7.7 mmol/L Standard Deviation 1.2	8.9 mmol/L Standard Deviation 1.5

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	Sitagliptin n=22 Participants Sitagliptin 100 mg/d for 6 weeks Sitagliptin: Sitagliptin 100 mg/d for 6 weeks	Placebo n=22 Participants Placebo for 6 weeks Placebo: Placebo for 6 weeks
Measurement of Insulin	161.1 pmol/L Standard Deviation 91.7	179.5 pmol/L Standard Deviation 88.1

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	Sitagliptin n=22 Participants Sitagliptin 100 mg/d for 6 weeks Sitagliptin: Sitagliptin 100 mg/d for 6 weeks	Placebo n=22 Participants Placebo for 6 weeks Placebo: Placebo for 6 weeks
Measurement of Apolipoprotein B48 and Apolipoprotein B100 Pool Sizes With Stable Isotope During Postprandial Period apolipoprotein B48 pool size	38.4 mg Standard Deviation 25.8	48.5 mg Standard Deviation 45.2
Measurement of Apolipoprotein B48 and Apolipoprotein B100 Pool Sizes With Stable Isotope During Postprandial Period apolipoprotein B100 pool size	488.0 mg Standard Deviation 210.2	537.8 mg Standard Deviation 232.0

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	Sitagliptin n=22 Participants Sitagliptin 100 mg/d for 6 weeks Sitagliptin: Sitagliptin 100 mg/d for 6 weeks	Placebo n=22 Participants Placebo for 6 weeks Placebo: Placebo for 6 weeks
Measurement of Apolipoprotein B48 and Apolipoprotein B100 Fractional Catabolic Rates With Stable Isotope During Postprandial Period apolipoprotein B48 fractional catabolic rate	6.2 pools/day Standard Deviation 2.5	6.3 pools/day Standard Deviation 3.2
Measurement of Apolipoprotein B48 and Apolipoprotein B100 Fractional Catabolic Rates With Stable Isotope During Postprandial Period apolipoprotein B100 fractional catabolic rate	5.9 pools/day Standard Deviation 2.3	5.9 pools/day Standard Deviation 2.6

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. Patrick Couture MD, PhD, FRCP

Laval University

Phone: 418-654-2106

Email: patrick.couture@crchul.ulaval.ca

Results disclosure agreements

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