Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189) (NCT NCT00875394)

Results Overview

Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

68 participants

Primary outcome timeframe

Baseline and 24 weeks

Results posted on

2017-05-30

Participant Flow

Patients were recruited in Principal Investigator's private practice, in Mexico City. First Patient Entered: 15 Feb 2007. Last Patient's Last Visit: 27 Jun 2008

Patients 30 to 78 years of age with inadequate glycemic control (Glycosylated hemoglobin A1C (A1C) 6.5 to 11%) on diet/exercise and metformin dosed at ≥1500 mg per day patients were to receive either sitagliptin added to ongoing metformin or "standard care" added to ongoing metformin.

Participant milestones

Participant milestones
Measure	Sitagliptin + Metformin Patients administered sitagliptin and metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".	Metformin Alone Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".
Overall Study STARTED	36	23	9
Overall Study COMPLETED	36	23	9
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin + Metformin n=36 Participants Patients administered sitagliptin and metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug n=23 Participants Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".	Metformin Alone n=9 Participants Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".	Total n=68 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 9.8 • n=5 Participants	56.0 years STANDARD_DEVIATION 8.5 • n=7 Participants	53.3 years STANDARD_DEVIATION 11.7 • n=5 Participants	54.69 years STANDARD_DEVIATION 9.55 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	19 Participants n=7 Participants	6 Participants n=5 Participants	50 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Body Mass Index (BMI)	29.0 kg/m2 STANDARD_DEVIATION 4.5 • n=5 Participants	28.8 kg/m2 STANDARD_DEVIATION 5.1 • n=7 Participants	28.3 kg/m2 STANDARD_DEVIATION 5.2 • n=5 Participants	28.84 kg/m2 STANDARD_DEVIATION 4.74 • n=4 Participants
Glycosylated Hemoglobin A1C (A1C)	8.8 Percent STANDARD_DEVIATION 1.5 • n=5 Participants	8.0 Percent STANDARD_DEVIATION 1.8 • n=7 Participants	8.2 Percent STANDARD_DEVIATION 1.1 • n=5 Participants	8.47 Percent STANDARD_DEVIATION 1.61 • n=4 Participants
Time since diagnosis of diabetes	8.9 Years STANDARD_DEVIATION 7.1 • n=5 Participants	6.8 Years STANDARD_DEVIATION 8.5 • n=7 Participants	10.9 Years STANDARD_DEVIATION 7.7 • n=5 Participants	8.43 Years STANDARD_DEVIATION 7.68 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Population: Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.

Outcome measures

Outcome data not reported

Adverse Events

Sitagliptin + Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metformin + Any Non-DPP-4i Oral Antidiabetic Drug

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Metformin Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sitagliptin + Metformin n=36 participants at risk Patients administered sitagliptin and metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug n=23 participants at risk Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".	Metformin Alone n=9 participants at risk Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".
Gastrointestinal disorders Nausea	0.00% 0/36	4.3% 1/23	0.00% 0/9
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/36	4.3% 1/23	0.00% 0/9

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