Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Sitagliptin; Drug: Sitagliptin (MK0431); Drug: Metformin - Rescue

Study type: Interventional

Funder types: Industry

Identifiers

NCT00087516

Formally-C0604MT2D

MK0431-021

0431-021

2006_413

Details and patient eligibility

About

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Enrollment: 741 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes mellitus
• Patient is not pregnant or breastfeeding
• Male or female patient unlikely to conceive
• Patient not on an antihyperglycemic drug

Exclusion criteria

• Patient has history of type 1 diabetes mellitus
• Patient has history of ketoacidosis
• Patient requires insulin within 8 weeks prior to start of study
• Patient on weight loss program and is not in maintenance phase
• Patient taking weight loss medication within 8 weeks prior to start of study
• Patient on or likely to require = 14 days or repeated courses of corticosteroids
• Patient taking immunosuppressive/immunomodulating medication
• Patient taking digoxin or other cardiac medication
• Patient has undergone surgical general anesthesia within 30 days prior to start of study
• Patient taking investigational drug within 8 weeks prior to start of study
• Patient is diagnosed with liver disease
• Patient has chronic myopathy, progressive neurological/neuromuscular disorder
• Patient has with severe cardiac conditions within the last 6 months
• Patient is Human immunodeficiency virus (HIV) positive
• Patient has hematological disorder
• Patient has history of malignancy
• Patient has history of alcohol or drug abuse within the past 3 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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741 participants in 4 patient groups, including a placebo group

Sitagliptin 100 mg/100 mg

Active Comparator group

Description:

Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )

Treatment:

Drug: Metformin - Rescue

Drug: Sitagliptin (MK0431)

Sitagliptin 200 mg/200 mg

Active Comparator group

Description:

Phase A and B: Oral tablets of sitagliptin 200 mg q.d

Treatment:

Drug: Metformin - Rescue

Drug: Sitagliptin

Placebo/Sitagliptin 100 mg

Placebo Comparator group

Description:

Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.

Treatment:

Drug: Placebo

Drug: Metformin - Rescue

Drug: Placebo

Placebo/Sitagliptin 200 mg

Placebo Comparator group

Description:

Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.

Treatment:

Drug: Placebo

Drug: Metformin - Rescue

Drug: Placebo