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

NCT ID: NCT00087516

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 741 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2007-02-28

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sitagliptin 100 mg/100 mg

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

Group Type: ACTIVE_COMPARATOR

Sitagliptin (MK0431)

Intervention Type: DRUG

Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

Metformin - Rescue

Intervention Type: DRUG

Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Sitagliptin 200 mg/200 mg

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

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.

Metformin - Rescue

Intervention Type: DRUG

Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Placebo/Sitagliptin 100 mg

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

Metformin - Rescue

Intervention Type: DRUG

Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Placebo/Sitagliptin 200 mg

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.

Metformin - Rescue

Intervention Type: DRUG

Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Interventions

Sitagliptin (MK0431)

Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

Intervention Type: DRUG

Sitagliptin

Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.

Intervention Type: DRUG

Placebo

Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

Intervention Type: DRUG

Placebo

Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.

Intervention Type: DRUG

Metformin - Rescue

Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Intervention Type: DRUG

Other Intervention Names

MK0431; Januvia; MK0431; Januvia; Metformin; Glucophage; Glucophage XR; Glumetza; Fortamet; Riomet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.

Reference Type: BACKGROUND

PMID: 17130196 (View on PubMed)

Other Identifiers

Formally-C0604MT2D

Identifier Type: -

Identifier Source: secondary_id

MK0431-021

Identifier Type: -

Identifier Source: secondary_id

2006_413

Identifier Type: -

Identifier Source: secondary_id

0431-021

Identifier Type: -

Identifier Source: org_study_id