Trial Outcomes & Findings for Incretin Effect in People With Impaired Fasting Glucose (NCT NCT00795275)

NCT ID: NCT00795275

Last Updated: 2021-04-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Baseline and 28 days
• Results posted on: 2021-04-05

Participant Flow

Participant milestones

Measure	People With Impaired Fasting Glucose people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Overall Study STARTED	11	15
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Incretin Effect in People With Impaired Fasting Glucose

Baseline characteristics by cohort

Measure	People With Impaired Fasting Glucose n=11 Participants people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance n=15 Participants people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	Total n=26 Participants Total of all reporting groups
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	15 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 2.3 • n=5 Participants	58 years STANDARD_DEVIATION 1.6 • n=7 Participants	59 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	15 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 28 days

Outcome measures

Measure	People With Impaired Fasting Glucose n=10 Participants people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance n=13 Participants people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Change in Endogenous Glucose Production Baseline	1.47 mg/kg/min Standard Deviation 0.08	1.46 mg/kg/min Standard Deviation 0.05
Change in Endogenous Glucose Production Day 28	1.44 mg/kg/min Standard Deviation 0.04	1.37 mg/kg/min Standard Deviation 0.07

PRIMARY outcome

Timeframe: Baseline and 28 days

Outcome measures

Measure	People With Impaired Fasting Glucose n=10 Participants people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance n=13 Participants people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Change in Insulin Secretion Baseline	104 pmol/l Standard Deviation 15	97 pmol/l Standard Deviation 6
Change in Insulin Secretion 28 Days	75 pmol/l Standard Deviation 8	71 pmol/l Standard Deviation 7

SECONDARY outcome

Timeframe: Baseline

Population: Despite significant efforts to recover the data, data for this outcome measure could not be obtained and is not available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 28 days

Outcome measures

Measure	People With Impaired Fasting Glucose n=10 Participants people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance n=13 Participants people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide Baseline	0.8 nmol/l Standard Deviation 0.05	0.7 nmol/l Standard Deviation 0.07
Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide Day 28	0.9 nmol/l Standard Deviation 0.03	0.7 nmol/l Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline and 28 days

Outcome measures

Measure	People With Impaired Fasting Glucose n=10 Participants people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance n=13 Participants people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon Baseline	62 ng/l Standard Deviation 2.8	63 ng/l Standard Deviation 4.3
Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon Day 28	61 ng/l Standard Deviation 3.1	66 ng/l Standard Deviation 4.0

SECONDARY outcome

Timeframe: Baseline and 28 days

Outcome measures

Measure	People With Impaired Fasting Glucose n=10 Participants people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance n=13 Participants people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1 Day 28	8.3 pmol/l Standard Deviation 2.6	5.4 pmol/l Standard Deviation 1.2
Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1 Baseline	7.5 pmol/l Standard Deviation 3.6	3.4 pmol/l Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and 28 days

Outcome measures

Measure	People With Impaired Fasting Glucose n=10 Participants people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance n=13 Participants people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Baseline and Change in Hormones, Substrates and Insulin Action: Lactate Baseline	0.4 mmol/l Standard Deviation 0.03	0.3 mmol/l Standard Deviation 0.03
Baseline and Change in Hormones, Substrates and Insulin Action: Lactate Day 28	0.4 mmol/l Standard Deviation 0.09	0.4 mmol/l Standard Deviation 0.04

SECONDARY outcome

Timeframe: Baseline and 28 days

Outcome measures

Measure	People With Impaired Fasting Glucose n=10 Participants people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance n=13 Participants people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Baseline and Change in Hormones, Substrates and Insulin Action: FFA Baseline	604 umol/l Standard Deviation 30	610 umol/l Standard Deviation 60
Baseline and Change in Hormones, Substrates and Insulin Action: FFA Day 28	631 umol/l Standard Deviation 51	547 umol/l Standard Deviation 44

SECONDARY outcome

Timeframe: Baseline and 28 days

Outcome measures

Measure	People With Impaired Fasting Glucose n=10 Participants people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	People With Normal Glucose Tolerance n=13 Participants people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol Baseline	91 umol/l Standard Deviation 6	85 umol/l Standard Deviation 7
Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol Day 28	93 umol/l Standard Deviation 6.5	85 umol/l Standard Deviation 5.7

Adverse Events

People With Impaired Fasting Glucose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

People With Normal Glucose Tolerance

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

Leigh Perreault, MD

University of Colorado Anschutz Medical Campus

Phone: 303-249-7732

Email: leigh.perreault@ucdenver.edu

Results disclosure agreements

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