Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Comparator: placebo to pioglitazone; Drug: Comparator: sitagliptin phosphate; Drug: Comparator: pioglitazone; Drug: Comparator: placebo to sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00511108

2007_530

0431-061

MK0431-061

Details and patient eligibility

About

A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.

Enrollment: 211 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has type 2 diabetes mellitus
• Male
• Female that is highly unlikely to become pregnant
• Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)

Exclusion criteria

• Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
• Patient has required insulin therapy within the past 12 weeks
• Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones [TZDs]) within the prior 12 weeks of the screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

211 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Arm 1: drug

Treatment:

Drug: Comparator: placebo to pioglitazone

Drug: Comparator: sitagliptin phosphate

2

Active Comparator group

Description:

Arm 2: active comparator

Treatment:

Drug: Comparator: pioglitazone

Drug: Comparator: placebo to sitagliptin

3

Experimental group

Description:

Arm 3: drug + active comparator

Treatment:

Drug: Comparator: pioglitazone

Drug: Comparator: sitagliptin phosphate

4

Placebo Comparator group

Description:

Arm 4: placebo comparator

Treatment:

Drug: Comparator: placebo to pioglitazone

Drug: Comparator: placebo to sitagliptin