MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

NCT00532935 | Completed Phase 3 Results

• 2 other identifiers: 0431A-0662007_510
• Study Type: interventional
• Target: 517
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in A1C at Week 32

  A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent

  Baseline and Week 32

Secondary Outcomes (4)

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1

  Baseline and Week 1

• Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32

  Baseline and Week 32

• Change From Baseline in FPG at Week 32

  Baseline and Week 32

• Percent of Participants With A1C <7.0% at Week 32

  Week 32

Study Arms (2)

1

EXPERIMENTAL

Sitagliptin phosphate (+) metformin hydrochloride

Drug: sitagliptin phosphate (+) metformin hydrochloride

2

ACTIVE COMPARATOR

pioglitazone

Drug: Comparator: pioglitazone

Interventions

sitagliptin phosphate (+) metformin hydrochloride DRUG

sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an \~32 wk treatment period

Also known as: Janumet

1

Comparator: pioglitazone DRUG

pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period.

Also known as: pioglitazone

2

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has type 2 diabetes mellitus
• Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

You may not qualify if:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
• Patient was on \>4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22.

  PMID: 22059736 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination; Pioglitazone

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; Biguanides; Guanidines; Amidines; Organic Chemicals; Drug Combinations; Pharmaceutical Preparations; Thiazolidinediones; Thiazoles; Sulfur Compounds

Limitations and Caveats

Unknown to the Sponsor and the investigators, two patients in the study were randomized twice (each at two different sites). Data for these patients were deemed unreliable and excluded from all analyses (efficacy and safety).

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

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 19, 2007
• First Posted: September 21, 2007
• Study Start: January 26, 2008
• Primary Completion: October 23, 2009
• Study Completion: October 23, 2009
• Last Updated: June 9, 2017
• Results First Posted: October 18, 2010

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share