Trial Outcomes & Findings for Incretins in Impaired Fasting Glucose (NCT NCT00364377)

Results Overview

fasting glucose taken as the mean of blood glucose measured at -30, -20, -10 and 0 minutes prior to each inpatient meal study

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

8 weeks

Results posted on

2011-12-06

Impaired Fasting Glucose (IFG) not on treatment with glucose-lowering medication

Participant milestones
Measure	Sitagliptin People with impaired fasting glucose treated with sitagliptin 100mg once daily.	Placebo People with impaired fasting glucose treated with placebo once daily.
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Incretins in Impaired Fasting Glucose

Baseline characteristics by cohort
Measure	Sitagliptin n=11 Participants People with impaired fasting glucose treated with sitagliptin 100mg once daily.	Placebo n=11 Participants People with impaired fasting glucose treated with placebo once daily.	Total n=22 Participants Total of all reporting groups
Age Continuous	55.2 years STANDARD_DEVIATION 2.5 • n=5 Participants	54.1 years STANDARD_DEVIATION 2.4 • n=7 Participants	54.7 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

Timeframe: 8 weeks

Population: Analysis was per protocol - all participants completed the intervention

fasting glucose taken as the mean of blood glucose measured at -30, -20, -10 and 0 minutes prior to each inpatient meal study

Outcome measures
Measure	Sitagliptin n=11 Participants People with impaired fasting glucose treated with sitagliptin 100mg once daily.	Placebo n=11 Participants People with impaired fasting glucose treated with placebo once daily.
Lowering of Fasting Glucose	5.78 mmol/l Standard Error 0.12	5.83 mmol/l Standard Error 0.12

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Sitagliptin n=11 participants at risk People with impaired fasting glucose treated with sitagliptin 100mg once daily.	Placebo n=11 participants at risk People with impaired fasting glucose treated with placebo once daily.
Skin and subcutaneous tissue disorders Rash	0.00% 0/11 • Twelve weeks	0.00% 0/11 • Twelve weeks

Mayo Clinic

Phone: 507-284-3754