MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

NCT00372060 | Completed Phase 3 Results

• 2 other identifiers: 0431-0552006_029
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12

  Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.

  12 Weeks

Secondary Outcomes (1)

• Change From Baseline in Fasting Plasma Glucose at Week 12

  12 Weeks

Other Outcomes (2)

• Change From Baseline in 2 Hour Postprandial Glucose at Week 12

  12 weeks

• Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52

  Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.

Study Arms (2)

1

EXPERIMENTAL

MK0431 + pioglitazone

Drug: sitagliptin phosphate; Drug: Comparator: pioglitazone

2

PLACEBO COMPARATOR

Placebo/MK0431 + pioglitazone

Drug: Comparator: sitagliptin phosphate (MK0431); Drug: Comparator: pioglitazone; Drug: Comparator: placebo (unspecified)

Interventions

sitagliptin phosphate DRUG

Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks

Also known as: MK0431

1

Comparator: sitagliptin phosphate (MK0431) DRUG

Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks

Also known as: MK0431

2

Comparator: pioglitazone DRUG

pioglitazone once daily for 52 weeks

1; 2

Comparator: placebo (unspecified) DRUG

Placebo once daily for 12 weeks

2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients Have Type 2 Diabetes Mellitus
• On Diet/Exercise Therapy And Pioglitazone As Monotherapy

You may not qualify if:

• Patients Have Type 1 Diabetes Mellitus

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Kashiwagi A, Kadowaki T, Tajima N, Nonaka K, Taniguchi T, Nishii M, Ferreira JC, Amatruda JM. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes. J Diabetes Investig. 2011 Oct 7;2(5):381-90. doi: 10.1111/j.2040-1124.2011.00120.x.

  PMID: 24843518 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Limitations and Caveats

Period II (Weeks 12-52) was open-label and uncontrolled, with all patients receiving sitagliptin. Results are pooled data from both treatment groups and should be considered in the context of the Type 2 Diabetes Mellitus (T2DM) population studied.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 6, 2006
• Study Start: August 21, 2006
• Primary Completion: February 5, 2008
• Study Completion: February 5, 2008
• Last Updated: May 12, 2017
• Results First Posted: March 31, 2009

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share