Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)

NCT01545388 | Completed Phase 3 Results

• 2 other identifiers: 0431A-136ONO-5435A
• Study Type: interventional
• Target: 337
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in HbA1c at 24 weeks.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)

  Based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, other prior antihyperglycemic agent (AHA) therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.

  Baseline and Week 24

• Percentage of Participants Who Experienced at Least One Adverse Event

  Up to 26 weeks

• Number of Participants Who Discontinued Study Drug Due to an Adverse Event

  Up to 24 weeks

Secondary Outcomes (1)

• Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)

  Baseline and Week 24

Study Arms (3)

Metformin 500 mg q.d.

EXPERIMENTAL

Participants will receive sitagliptin daily (continuing their pre-study dose), 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.

Drug: Sitagliptin; Drug: Metformin; Drug: Placebo

Metformin 250 mg b.i.d.

EXPERIMENTAL

Participants will receive sitagliptin daily (continuing their pre-study dose), 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.

Drug: Sitagliptin; Drug: Metformin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will receive sitagliptin daily (continuing their pre-study dose), 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.

Drug: Sitagliptin; Drug: Placebo

Interventions

Sitagliptin DRUG

Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose)

Also known as: MK-0431/ONO-5435

Metformin 250 mg b.i.d.; Metformin 500 mg q.d.; Placebo

Metformin DRUG

Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks

Metformin 500 mg q.d.

Placebo DRUG

Placebo to match metformin 250 mg tablets, orally, for 24 weeks

Metformin 250 mg b.i.d.; Metformin 500 mg q.d.; Placebo

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus (T2DM)
• Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4 weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c ≥ 6.0% and ≤ 9.0%; or
• Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10 weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c ≥ 6.5% and \< 10.0%

You may not qualify if:

• Type 1 diabetes mellitus,
• Secondary diabetes mellitus, or
• Gestational diabetes mellitus

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin

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

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

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: March 1, 2012
• First Posted: March 6, 2012
• Study Start: February 23, 2012
• Primary Completion: March 12, 2013
• Study Completion: March 12, 2013
• Last Updated: August 22, 2018
• Results First Posted: March 26, 2014

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share