A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)

NCT ID: NCT00813995

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-09
• Study Completion Date: 2010-08-09

Brief Summary

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

Conditions

Type 2 Diabetes Mellitus

Study Design

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

Study Groups

Sitagliptin

Group Type: EXPERIMENTAL

Comparator: Sitagliptin phosphate

Intervention Type: DRUG

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Interventions

Comparator: Sitagliptin phosphate

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Intervention Type: DRUG

Comparator: Placebo

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Intervention Type: DRUG

Other Intervention Names

GLUCOPHAGE®; GLUCOPHAGE®

Eligibility Criteria

Inclusion Criteria

• 18 - 78 years of age
• Currently on metformin monotherapy

Exclusion Criteria

• History of Type 1 diabetes mellitus or ketoacidosis
• Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
• Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
• Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
• History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
• HIV positive
• Pregnant, breast-feeding or planning to become pregnant during the study
• User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 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

Yang W, Guan Y, Shentu Y, Li Z, Johnson-Levonas AO, Engel SS, Kaufman KD, Goldstein BJ, Alba M. The addition of sitagliptin to ongoing metformin therapy significantly improves glycemic control in Chinese patients with type 2 diabetes. J Diabetes. 2012 Sep;4(3):227-37. doi: 10.1111/j.1753-0407.2012.00213.x.

Reference Type: DERIVED

PMID: 22672586 (View on PubMed)

Other Identifiers

2008_601

Identifier Type: -

Identifier Source: secondary_id

0431-074

Identifier Type: -

Identifier Source: org_study_id