Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

NCT01076088 | Completed Phase 3 Results

• 2 other identifiers: 0431-1212010_514
• Study Type: interventional
• Target: 744
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1C (A1C) at Week 24

  A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

  Baseline and Week 24

Secondary Outcomes (2)

• Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24

  Baseline and Week 24

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

  Baseline and Week 24

Study Arms (6)

Sitagliptin 50 mg + metformin 500 mg

EXPERIMENTAL

Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks.

Drug: Sitagliptin 50 mg; Drug: Metformin 500 mg

Sitagliptin 50 mg + metformin 850 mg

EXPERIMENTAL

Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks.

Drug: Sitagliptin 50 mg; Drug: Metformin 850 mg

Metformin 500 mg

ACTIVE COMPARATOR

Metformin 500 mg twice daily for 24 weeks.

Drug: Metformin 500 mg

Metformin 850 mg

ACTIVE COMPARATOR

Metformin 850 mg twice daily for 24 weeks.

Drug: Metformin 850 mg

Sitagliptin 100 mg

EXPERIMENTAL

Sitagliptin 100 mg once daily for 24 weeks.

Drug: Sitagliptin 100 mg

Placebo

PLACEBO COMPARATOR

Matching placebo tablets for 24 weeks.

Drug: Placebo

Interventions

Sitagliptin 50 mg DRUG

Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.

Also known as: Januvia®, Tesavel®, Xelevia®, Ristaben®

Sitagliptin 50 mg + metformin 500 mg; Sitagliptin 50 mg + metformin 850 mg

Metformin 500 mg DRUG

Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.

Also known as: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

Metformin 500 mg; Sitagliptin 50 mg + metformin 500 mg

Sitagliptin 100 mg DRUG

Sitagliptin 100 mg once daily for 24 weeks.

Also known as: Januvia®, Tesavel®, Xelevia®, Ristaben®

Sitagliptin 100 mg

Placebo DRUG

Matching placebo tablets to sitagliptin or metformin for 24 weeks.

Placebo

Metformin 850 mg DRUG

Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.

Also known as: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

Metformin 850 mg; Sitagliptin 50 mg + metformin 850 mg

Eligibility Criteria

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

You may qualify if:

• has type 2 diabetes mellitus
• is male, a female who cannot have children, or a female who agrees to use birth control during the study
• is not on an antihyperglycemic agent (AHA) (hemoglobin A1c \[A1C\] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

You may not qualify if:

• Patient has type 1 diabetes mellitus or ketoacidosis
• Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
• Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
• Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
• Patient is HIV positive
• Patient is pregnant

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.

  PMID: 27181998 RESULT

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

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: February 24, 2010
• First Posted: February 25, 2010
• Study Start: November 15, 2010
• Primary Completion: December 24, 2012
• Study Completion: December 24, 2012
• Last Updated: May 23, 2017
• Results First Posted: February 6, 2014

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share