Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: sitagliptin; Drug: rosiglitazone; Drug: Comparator: Placebo; Drug: metformin; Drug: glipizide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00350779

2006_507

0431-052

MK0431-052

Details and patient eligibility

About

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.

Enrollment: 262 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has type 2 diabetes mellitus
• Patient is inadequately controlled while taking two oral antidiabetic medications

Exclusion criteria

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient required insulin therapy within the prior 3 months
• Patient has been taking Byetta (R) (exenatide) within the prior 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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262 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Sitagliptin

Treatment:

Drug: glipizide

Drug: metformin

Drug: rosiglitazone

Drug: sitagliptin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: glipizide

Drug: Comparator: Placebo

Drug: metformin

Drug: rosiglitazone