- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00885352
Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
April 27, 2017 updated by: Merck Sharp & Dohme LLC
A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK-0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Metformin and Pioglitazone
This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
313
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- has type 2 diabetes and is at least 18 years of age and no older than 78 years of age
- is male or is a female who is unlikely to conceive children
- is on stable doses of a peroxisome proliferator-activated receptor gamma agonist and metformin OR metformin and a sulfonylurea agent
Exclusion Criteria:
- has type 1 diabetes
- has taken a dipeptidyl peptidase (DPP-4) inhibitor or a glucagon-like peptide-1 (GLP-1) analogue
- is on a weight loss program that is not in the maintenance phase or has started a weight loss medication within 8 weeks of screening
- has had surgery within 30 days of screening or has major surgery planned during the study
- is on or is likely to require treatment with corticosteroids for more than 2 weeks
- has a history of active liver disease, including hepatitis B or C, cirrhosis, or gallbladder disease
- is human immunodeficiency virus (HIV) positive
- has congestive heart failure, or has had new or worsening symptoms of coronary heart disease within 3 months prior to screening
- has had acute coronary syndrome, coronary artery intervention, or stroke within 3 months of screening
- has severe active peripheral vascular disease
- has a history of cancer or blood disorder
- is pregnant or breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sitagliptin
Sitagliptin 100 mg tablet orally once daily for 26 weeks.
|
Sitagliptin 100 mg tablet orally once daily for 26 weeks.
Other Names:
Participants taking 30 mg or more pioglitazone oral tablet(s) daily at screening in combination with metformin will enter a 4-week dose-stable period followed by a 2-week single-blind run-in and a 26-week treatment period.
Participants taking 4 mg or more rosiglitazone oral tablet(s) daily at screening in combination with metformin were to be switched to a corresponding dose of pioglitazone prior to starting a 4-week dose-stable period.
Participants who are taking less than 30 mg/day or no pioglitazone at screening will be titrated to a stable dose of at least 30 mg pioglitazone once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period.
Total treatment with pioglitazone will be up to 42 weeks.
Other Names:
Participants taking 1500 mg or more metformin oral tablet(s) and at least 30 mg pioglitazone or 4 mg rosiglitazone daily at screening will enter a 4-week dose-stable period followed by a 2-week single-blind placebo run-in, and a 26-week treatment period.
Participants who are taking less than 1500 mg/day metformin at screening will be titrated to a stable dose of at least 1500 mg metformin once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period.
Total treatment with metformin will be up to 42 weeks.
Other Names:
Participants not meeting specific glycemic controls during the 26-week treatment period will use glipizide oral tablets as rescue therapy.
In countries where glipizide is not available, participants will receive a sulfonylurea marketed in that country.
Other Names:
|
Placebo Comparator: Placebo
Placebo to sitagliptin orally once daily for 26 weeks.
|
Participants taking 30 mg or more pioglitazone oral tablet(s) daily at screening in combination with metformin will enter a 4-week dose-stable period followed by a 2-week single-blind run-in and a 26-week treatment period.
Participants taking 4 mg or more rosiglitazone oral tablet(s) daily at screening in combination with metformin were to be switched to a corresponding dose of pioglitazone prior to starting a 4-week dose-stable period.
Participants who are taking less than 30 mg/day or no pioglitazone at screening will be titrated to a stable dose of at least 30 mg pioglitazone once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period.
Total treatment with pioglitazone will be up to 42 weeks.
Other Names:
Participants taking 1500 mg or more metformin oral tablet(s) and at least 30 mg pioglitazone or 4 mg rosiglitazone daily at screening will enter a 4-week dose-stable period followed by a 2-week single-blind placebo run-in, and a 26-week treatment period.
Participants who are taking less than 1500 mg/day metformin at screening will be titrated to a stable dose of at least 1500 mg metformin once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period.
Total treatment with metformin will be up to 42 weeks.
Other Names:
Participants not meeting specific glycemic controls during the 26-week treatment period will use glipizide oral tablets as rescue therapy.
In countries where glipizide is not available, participants will receive a sulfonylurea marketed in that country.
Other Names:
Placebo to sitagliptin 100 mg tablet orally once daily for 26 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Hemoglobin A1c (A1C) at Week 26
Time Frame: Baseline and Week 26
|
Change from baseline reflects the Week 26 value minus the baseline value.
A1C represents the percentage of glycosylated hemoglobin.
|
Baseline and Week 26
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26
Time Frame: Baseline and Week 26
|
Change from baseline reflects the Week 26 value minus the baseline value.
|
Baseline and Week 26
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time Frame: Baseline and Week 26
|
Change from baseline reflects the Week 26 value minus the baseline value.
|
Baseline and Week 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2009
Primary Completion (Actual)
November 10, 2010
Study Completion (Actual)
November 10, 2010
Study Registration Dates
First Submitted
April 20, 2009
First Submitted That Met QC Criteria
April 20, 2009
First Posted (Estimate)
April 21, 2009
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
April 27, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Metformin
- Pioglitazone
- Sitagliptin Phosphate
- Glipizide
Other Study ID Numbers
- 0431-128
- 2009_577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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