Trial Outcomes & Findings for A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED) (NCT NCT00411554)

NCT ID: NCT00411554

Last Updated: 2016-02-05

Results Overview

HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 319 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2016-02-05

Participant Flow

Phase III. First patient in: 6 January 2007. Last patient, last visit: 15 August 2007. The study was conducted at 71 centers in Japan.

Patients at least 20 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and <10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.

Participant milestones

Measure	Sitagliptin 50 mg QD The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).	Voglibose 0.2 mg TID The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
Overall Study STARTED	163	156
Overall Study COMPLETED	155	147
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Measure	Sitagliptin 50 mg QD The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).	Voglibose 0.2 mg TID The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
Overall Study Adverse Event	2	4
Overall Study Lack of Efficacy	2	5
Overall Study Withdrawal by Subject	3	0
Overall Study Patient Moved	1	0

Baseline Characteristics

A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

Baseline characteristics by cohort

Measure	Sitagliptin 50 mg QD n=163 Participants The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).	Voglibose 0.2 mg TID n=156 Participants The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).	Total n=319 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 10.1 • n=93 Participants	60.6 years STANDARD_DEVIATION 10.0 • n=4 Participants	60.7 years STANDARD_DEVIATION 10.0 • n=27 Participants
Sex: Female, Male Female	45 Participants n=93 Participants	62 Participants n=4 Participants	107 Participants n=27 Participants
Sex: Female, Male Male	118 Participants n=93 Participants	94 Participants n=4 Participants	212 Participants n=27 Participants
Fasting Plasma Glucose (FPG)	148.7 mg/dL STANDARD_DEVIATION 34.2 • n=93 Participants	148.9 mg/dL STANDARD_DEVIATION 31.0 • n=4 Participants	148.8 mg/dL STANDARD_DEVIATION 32.6 • n=27 Participants
Hemoglobin A1c (HbA1c)	7.8 percent STANDARD_DEVIATION 0.9 • n=93 Participants	7.8 percent STANDARD_DEVIATION 0.9 • n=4 Participants	7.8 percent STANDARD_DEVIATION 0.9 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for major protocol violations.

HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.

Outcome measures

Measure	Sitagliptin 50 mg QD n=155 Participants The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).	Voglibose 0.2 mg TID n=146 Participants The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
Change From Baseline in HbA1c at Week 12	-0.70 Percent Interval -0.78 to -0.62	-0.30 Percent Interval -0.39 to -0.22

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.

Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.

Outcome measures

Measure	Sitagliptin 50 mg QD n=155 Participants The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).	Voglibose 0.2 mg TID n=146 Participants The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
Change From Baseline in Fasting Plasma Glucose at Week 12	-19.6 mg/dL Interval -22.8 to -16.4	-8.9 mg/dL Interval -12.2 to -5.5

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.

Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.

Outcome measures

Measure	Sitagliptin 50 mg QD n=152 Participants The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).	Voglibose 0.2 mg TID n=146 Participants The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
Change From Baseline in 2 Hour Postprandial Glucose at Week 12	-51.0 mg/dL Interval -56.5 to -45.4	-32.2 mg/dL Interval -37.9 to -26.5

Adverse Events

Sitagliptin 50 mg QD

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Voglibose 0.2 mg TID

Serious events: 2 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sitagliptin 50 mg QD The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).	Voglibose 0.2 mg TID The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
Infections and infestations Cellulitis	0.61% 1/163	0.00% 0/156
Injury, poisoning and procedural complications Foot fracture	0.00% 0/163	0.64% 1/156
Gastrointestinal disorders Crohn's disease	0.00% 0/163	0.64% 1/156

Other adverse events

Measure	Sitagliptin 50 mg QD The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).	Voglibose 0.2 mg TID The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
Gastrointestinal disorders Abdominal distension	4.3% 7/163	9.0% 14/156
Gastrointestinal disorders Diarrhoea	2.5% 4/163	7.7% 12/156
Gastrointestinal disorders Flatulence	4.3% 7/163	10.9% 17/156
Infections and infestations Nasopharyngitis	13.5% 22/163	15.4% 24/156
Investigations Alanine aminotransferase increased	0.61% 1/163	7.1% 11/155

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER