A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

NCT01076075 | Completed Phase 3 Results

• 3 other identifiers: 0431-2292010_513MK-0431-229
• Study Type: interventional
• Target: 427
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

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

  Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.

  Baseline and Week 24

• Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54

  Week 0 to Week 54

• Number of Participants Discontinuing Study Drug Due to An Adverse Event

  Week 0 to Week 54

Secondary Outcomes (2)

• Change From Baseline in 2-hour Post-Meal Glucose at Week 24

  Baseline and Week 24

• Change From Baseline in Fasting Plasma Glucose at Week 24

  Baseline to Week 24

Study Arms (2)

placebo/pioglitazone

ACTIVE COMPARATOR

Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg

Drug: Comparator: placebo to Sitagliptin; Drug: Comparator: pioglitazone; Drug: Glimepiride or gliclazide; Drug: Metformin; Drug: Pioglitazone rescue therapy

Sitagliptin

EXPERIMENTAL

Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone

Drug: Sitagliptin phosphate; Drug: Comparator: placebo to pioglitazone; Drug: Glimepiride or gliclazide; Drug: Metformin; Drug: Pioglitazone rescue therapy

Interventions

Sitagliptin phosphate DRUG

Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks

Also known as: Januvia

Sitagliptin

Comparator: placebo to pioglitazone DRUG

Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks

Sitagliptin

Comparator: placebo to Sitagliptin DRUG

Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks

placebo/pioglitazone

Comparator: pioglitazone DRUG

Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks

Also known as: Actos;

placebo/pioglitazone

Glimepiride or gliclazide DRUG

Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide

Sitagliptin; placebo/pioglitazone

Metformin DRUG

Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of metformin; Phase B (Weeks 24- 54): stable dose, as prescribed by investigator, of metformin

Sitagliptin; placebo/pioglitazone

Pioglitazone rescue therapy DRUG

Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.

Also known as: Actos

Sitagliptin; placebo/pioglitazone

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes mellitus
• Hemoglobin A1C of ≥7.5% and ≤10.5%
• Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start
• Male, or a female who is highly unlikely to conceive

You may not qualify if:

• Type 1 diabetes mellitus or ketoacidosis
• Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start
• On a weight loss program not in the maintenance phase or on a weight loss medication
• History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
• HIV positive
• Pregnant

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Moses RG, Round E, Shentu Y, Golm GT, O'neill EA, Gantz I, Engel SS, Kaufman KD, Goldstein BJ. A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control. J Diabetes. 2016 Sep;8(5):701-11. doi: 10.1111/1753-0407.12351. Epub 2016 Feb 3.

  PMID: 26625270 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Pioglitazone; glimepiride; Gliclazide; 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; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Biguanides; Guanidines; Amidines

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: June 3, 2010
• Primary Completion: July 11, 2011
• Study Completion: January 19, 2012
• Last Updated: June 5, 2017
• Results First Posted: August 7, 2012

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share