Trial Outcomes & Findings for Sitagliptin in Combination With Metformin and Sulfonylurea (NCT NCT00686634)

NCT ID: NCT00686634

Last Updated: 2014-11-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 108 participants
• Primary outcome timeframe: Baseline, 4 months
• Results posted on: 2014-11-26

Participant Flow

Participant milestones

Measure	Sitagliptin Treatment Sitagliptin 100 mg orally once daily
Overall Study STARTED	108
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Sitagliptin Treatment Sitagliptin 100 mg orally once daily
Overall Study Protocol Violation	6

Baseline Characteristics

Sitagliptin in Combination With Metformin and Sulfonylurea

Baseline characteristics by cohort

Measure	Sitagliptin Treatment n=108 Participants Sitagliptin 100 mg once daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	104 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	50.7 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment United States	108 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 months

Population: Last Observation Carried Forward for subjects with paradoxical worsening of control (switched to alternate treatment before 4 months)

Outcome measures

Measure	Sitagliptin n=102 Participants Sitagliptin 100 mg daily
Hemoglobin A1c (HbA1c) Change From Baseline	-1.3 percentage Standard Deviation 1.8

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Measure	Sitagliptin n=102 Participants Sitagliptin 100 mg daily
Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months	47 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Sitagliptin n=44 Participants Sitagliptin 100 mg daily
Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year	26 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Sitagliptin n=108 Participants Sitagliptin 100 mg daily
Number of Adverse Events Hypoglycemia	3 Adverse event
Number of Adverse Events Other adverse events	3 Adverse event

Adverse Events

Sitagliptin Treatment

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

Stanley H. Hsia, MD

Charles R. Drew University of Medicine and Science

Phone: 323-357-3633

Email: stanleyhsia@cdrewu.edu

Results disclosure agreements

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