A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 78 years
• All sexes
• No healthy volunteers
• Adult, Older adult

About this study

Official title: A Phase III, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin

Conditions

Type 2 Diabetes Mellitus

Being tested

Sitagliptin phosphate, Comparator: placebo to pioglitazone, Comparator: placebo to Sitagliptin, Comparator: pioglitazone, Glimepiride or gliclazide

Keywords

Type 2 Diabetes Mellitus

Medical subject headings

Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Sitagliptin phosphateDrug

  Also called Januvia

  Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks

• Comparator: placebo to pioglitazoneDrug

  Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks

• Comparator: placebo to SitagliptinDrug

  Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks

• Comparator: pioglitazoneDrug

  Also called Actos;

  Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks

• Glimepiride or gliclazideDrug

  Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide

• MetforminDrug

  Phase A (Weeks 0-24): stable dose, as prescribed

  by investigator, of metformin; Phase B (Weeks 24-

  54): stable dose, as prescribed by investigator, of

  metformin

• Pioglitazone rescue therapyDrug

  Also called Actos

  Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change From Baseline in Hemoglobin A1C (%) at Week 24

   Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.

   Measured: Baseline and Week 24

2. Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54

   Measured: Week 0 to Week 54

3. Number of Participants Discontinuing Study Drug Due to An Adverse Event

   Measured: Week 0 to Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Feb 2010 (estimated)
2. Study start3 Jun 2010
3. Primary completion11 Jul 2011
4. Study completion19 Jan 2012

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
• More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.