Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT00337610

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-08-31

Brief Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

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

Study Groups

sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a day

Group Type: EXPERIMENTAL

sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day

Intervention Type: DRUG

Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/day

Group Type: PLACEBO_COMPARATOR

comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day

Intervention Type: DRUG

Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

Interventions

sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day

Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

Intervention Type: DRUG

comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day

Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

Intervention Type: DRUG

Other Intervention Names

Januvia

Eligibility Criteria

Inclusion Criteria

• Patient has type 2 diabetes mellitus
• Males
• Females who are highly unlikely to become pregnant
• Patients poorly controlled while taking one or 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 8 weeks
• Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit

• 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

Raz I, Chen Y, Wu M, Hussain S, Kaufman KD, Amatruda JM, Langdon RB, Stein PP, Alba M. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008 Feb;24(2):537-50. doi: 10.1185/030079908x260925.

Reference Type: BACKGROUND

PMID: 18194595 (View on PubMed)

Other Identifiers

2006_017

Identifier Type: -

Identifier Source: secondary_id

0431-053

Identifier Type: -

Identifier Source: org_study_id