Trial Outcomes & Findings for Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059) (NCT NCT00704132)

Results Overview

Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

57 participants

Primary outcome timeframe

Baseline and Week 6

Results posted on

2017-05-12

Participant Flow

57 participants were enrolled in this study. Of these, 7 participants with normal fasting glucose (NFG) only underwent pre-randomization experiments and did not receive an allocation number, were not randomized to one of the treatment groups, and did not receive double-blind study medication.

Participant milestones

Participant milestones
Measure	Sitagliptin Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.	Placebo Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
Overall Study STARTED	26	24
Overall Study COMPLETED	25	22
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.	Placebo Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
Overall Study Clinical Adverse Experience	1	0
Overall Study Lack of Efficacy	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin n=26 Participants Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.	Placebo n=24 Participants Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.	Total n=50 Participants Total of all reporting groups
Age, Customized	26 participants n=5 Participants	24 participants n=7 Participants	50 participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6

Population: Full-Analysis-Set (FAS) population, which includes all randomized participants who had a baseline value, received at least one dose of randomized treatment, and had a measurement at Week 6.

Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.

Outcome measures

Outcome measures
Measure	Sitagliptin n=25 Participants Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.	Placebo n=22 Participants Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6	-83.9 mg*hr/dL 95% Confidence Interval 87.7 • Interval -125.9 to -41.9	27.0 mg*hr/dL 95% Confidence Interval 84.3 • Interval -16.0 to 70.1

Adverse Events

Sitagliptin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sitagliptin n=26 participants at risk Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.	Placebo n=24 participants at risk Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
Ear and labyrinth disorders Vertigo positional	3.8% 1/26 • Number of events 1 The analyses for all safety outcomes used the All Patients as Treated (APaT) approach. The APaT population used all randomized participants who received at least 1 dose of study therapy.	0.00% 0/24 The analyses for all safety outcomes used the All Patients as Treated (APaT) approach. The APaT population used all randomized participants who received at least 1 dose of study therapy.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER