A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Type II Diabetes Mellitus

Treatments: Drug: Sitagliptin; Drug: Rescue; Drug: Metformin; Drug: Placebo to sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00481663

2007_570

0431-014

Details and patient eligibility

About

A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week 106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering hemoglobin A1C (HbA1c).

Enrollment: 555 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and non-pregnant women
• Fasting plasma glucose >= 130 mg/dL
• HbA1c >=6.5% and >10.0%

Exclusion criteria

• You have a history of type I diabetes
• You are on a weight loss program with ongoing weight loss or taking weight loss medication
• You have had surgery within 30 days
• You hvae hepatitis B or C.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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555 participants in 5 patient groups, including a placebo group

Sitagliptin 25 mg once daily

Experimental group

Description:

Sitaglipin (MK-0431), 25 mg, once daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods.

Treatment:

Drug: Rescue

Drug: Sitagliptin

Sitagliptin 50 mg once daily

Experimental group

Description:

Sitagliptin, 50 mg, once daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods.

Treatment:

Drug: Rescue

Drug: Sitagliptin

Sitaglipin 100 mg once daily

Experimental group

Description:

Sitagliptin, 100 mg, once daily for 158 weeks, orally

Treatment:

Drug: Rescue

Drug: Sitagliptin

Sitagliptin 50 mg twice daily

Experimental group

Description:

Sitagliptin 50 mg, twice daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods.

Treatment:

Drug: Rescue

Drug: Sitagliptin

Placebo to Sitagliptin → Metformin

Placebo Comparator group

Description:

Placebo to Sitagliptin, once daily, orally for 12 weeks. Participants randomized to the placebo treatment group during the base study were reallocated to treatment with metformin 850 mg twice daily (b.i.d., initiated with 850 mg q.d. for 4 weeks then force titrated to 850 mg b.i.d.) during either the first or initiation of the second extensions study periods.

Treatment:

Drug: Placebo to sitagliptin

Drug: Rescue

Drug: Metformin