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

NCT ID: NCT00395343

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 641 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-11
• Study Completion Date: 2008-10-13

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

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

Study Groups

1

sitagliptin

Group Type: EXPERIMENTAL

sitagliptin phosphate

Intervention Type: DRUG

sitagliptin 100 mg tablet qd for a 24-wk treatment period.

2

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator : placebo (unspecified)

Intervention Type: DRUG

sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.

Interventions

sitagliptin phosphate

sitagliptin 100 mg tablet qd for a 24-wk treatment period.

Intervention Type: DRUG

Comparator : placebo (unspecified)

sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.

Intervention Type: DRUG

Other Intervention Names

MK0431; Januvia™

Eligibility Criteria

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

• Minimum Eligible Age: 21 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

Vilsboll T, Rosenstock J, Yki-Jarvinen H, Cefalu WT, Chen Y, Luo E, Musser B, Andryuk PJ, Ling Y, Kaufman KD, Amatruda JM, Engel SS, Katz L. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Feb;12(2):167-77. doi: 10.1111/j.1463-1326.2009.01173.x.

Reference Type: RESULT

PMID: 20092585 (View on PubMed)

Other Identifiers

MK0431-051

Identifier Type: -

Identifier Source: secondary_id

2006_532

Identifier Type: -

Identifier Source: secondary_id

0431-051

Identifier Type: -

Identifier Source: org_study_id