MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)

NCT ID: NCT00837577

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-05
• Study Completion Date: 2010-08-11

Brief Summary

The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Study Design

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

Study Groups

Sitagliptin/Sitagliptin

Group Type: EXPERIMENTAL

Sitagliptin

Intervention Type: DRUG

Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period).

Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.

Voglibose

Intervention Type: DRUG

All participants received a stable dose of voglibose, in

accordance with the package insert, throughout the study.

Placebo/Sitagliptin

Group Type: EXPERIMENTAL

Comparator: Placebo

Intervention Type: DRUG

Placebo to sitagliptin once daily for 12 weeks (double-blind period)

Sitagliptin

Intervention Type: DRUG

Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period).

Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.

Voglibose

Intervention Type: DRUG

All participants received a stable dose of voglibose, in

accordance with the package insert, throughout the study.

Interventions

Comparator: Placebo

Placebo to sitagliptin once daily for 12 weeks (double-blind period)

Intervention Type: DRUG

Sitagliptin

Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period).

Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.

Intervention Type: DRUG

Voglibose

All participants received a stable dose of voglibose, in

accordance with the package insert, throughout the study.

Intervention Type: DRUG

Other Intervention Names

Januvia; MK0431; ONO-5435

Eligibility Criteria

Inclusion Criteria

• Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy

Exclusion Criteria

• Patients Have A History Of Type 1 Diabetes Mellitus

• Minimum Eligible Age: 20 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

Tajima N, Kadowaki T, Okamoto T, Sato A, Okuyama K, Minamide T, Arjona Ferreira JC. Sitagliptin added to voglibose monotherapy improves glycemic control in patients with type 2 diabetes. J Diabetes Investig. 2013 Nov 27;4(6):595-604. doi: 10.1111/jdi.12116. Epub 2013 Jul 21.

Reference Type: RESULT

PMID: 24843714 (View on PubMed)

Other Identifiers

2009_535

Identifier Type: -

Identifier Source: secondary_id

0431-104

Identifier Type: -

Identifier Source: org_study_id