Sitagliptin Added-on to Insulin Study (0431-051)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator : placebo (unspecified); Drug: sitagliptin phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395343

2006_532

MK0431-051

0431-051

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 insulin or insulin/metformin combination therapy.

Enrollment: 641 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has type 2 diabetes mellitus
• Patient is poorly controlled while on insulin or insulin and metformin

Exclusion criteria

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient is taking oral antidiabetic agents other than metformin during the past 3 months
• Patient is currently on treatment with daily use of pre-prandial short-acting or rapid-acting insulin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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641 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

sitagliptin

Treatment:

Drug: sitagliptin phosphate

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator : placebo (unspecified)