A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)

NCT00813995 | Completed Phase 3 Results

• 2 other identifiers: 0431-0742008_601
• Study Type: interventional
• Target: 395
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

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 (4)

• Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day

  Baseline and Week 24

• Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day

  Baseline and Week 24

• Change From Baseline in 2-hour Post-meal Glucose (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 (2)

Sitagliptin

EXPERIMENTAL

Drug: Comparator: Sitagliptin phosphate

Placebo

PLACEBO COMPARATOR

Drug: Comparator: Placebo

Interventions

Comparator: Sitagliptin phosphate DRUG

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Also known as: GLUCOPHAGE®

Sitagliptin

Comparator: Placebo DRUG

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Also known as: GLUCOPHAGE®

Placebo

Eligibility Criteria

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

You may qualify if:

• years of age
• Currently on metformin monotherapy

You may not qualify if:

• History of Type 1 diabetes mellitus or ketoacidosis
• Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
• Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
• Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
• History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
• HIV positive
• Pregnant, breast-feeding or planning to become pregnant during the study
• User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Yang W, Guan Y, Shentu Y, Li Z, Johnson-Levonas AO, Engel SS, Kaufman KD, Goldstein BJ, Alba M. The addition of sitagliptin to ongoing metformin therapy significantly improves glycemic control in Chinese patients with type 2 diabetes. J Diabetes. 2012 Sep;4(3):227-37. doi: 10.1111/j.1753-0407.2012.00213.x.

  PMID: 22672586 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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: December 19, 2008
• First Posted: December 23, 2008
• Study Start: December 9, 2008
• Primary Completion: August 9, 2010
• Study Completion: August 9, 2010
• Last Updated: May 12, 2017
• Results First Posted: September 13, 2011

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share