Trial Outcomes & Findings for Effects of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Hormonal Responses to Macronutrient Ingestion (NCT NCT00885638)

Results Overview

Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

300 min

Results posted on

2014-01-30

Participant Flow

Recruitment was performed during 2011 to Lund University

Participant milestones

Participant milestones
Measure	Placebo First, Then Sitagliptin First intervention 1 day, washout 14 days, second intervention 1 day	Sitagliptin First, Then Placebo First intervention 1 day, washout 14 days, second intervention 1 day
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Hormonal Responses to Macronutrient Ingestion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants Placebo first, then sitagliptin or sitagliptin first, then placebo
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	22.5 years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment Sweden	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 300 min

Population: Completer population

Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for placebo	Sitagliptin n=12 Participants Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for sitagliptin
Glucagon-like Peptide-1 Secretion After Meal Ingestion	0.82 nmol/l/min Standard Error 0.11	1.24 nmol/l/min Standard Error 0.13

SECONDARY outcome

Timeframe: 300 min

Population: Completer population

Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for placebo	Sitagliptin n=12 Participants Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for sitagliptin
Insulin Secretion After Ingestion of Meal	29.6 mol/l/min Standard Error 2.8	24.7 mol/l/min Standard Error 2.2

Adverse Events

All Study Participants

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

Professor Bo Ahrén

Lund University

Phone: +46462220758

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place