Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00086502 |
Recruitment Status :
Completed
First Posted : July 5, 2004
Results First Posted : April 19, 2010
Last Update Posted : February 5, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Comparator: Sitagliptin Drug: Comparator: Placebo Drug: Comparator: Pioglitazone Drug: Metformin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 353 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | November 2005 |
Actual Study Completion Date : | November 2005 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sitagliptin 100 mg
Sitagliptin 100 mg
|
Drug: Comparator: Sitagliptin
Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24
Other Name: Januvia Drug: Comparator: Pioglitazone Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8
Other Name: ACTOS Drug: Metformin Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8 |
Placebo Comparator: Placebo
Placebo
|
Drug: Comparator: Placebo
Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24 Drug: Comparator: Pioglitazone Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8
Other Name: ACTOS Drug: Metformin Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8 |
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [ Time Frame: Baseline and week 24 ]HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and week 24 ]Change from baseline at Week 24 is defined as Week 24 minus Week 0.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has type 2 diabetes mellitus (T2DM)
- Patient is 18 years of age (or older)
- Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period
Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Patient required insulin within the prior 8 weeks
- Patient is on a weight loss program and is not in the maintenance phase
- Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
- Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)
- Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease
- Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
- Patient has any of the following disorders within the past 6 months:
Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder.
- Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months
- Patient has severe peripheral vascular disease
- Patient has congestive heart failure
- Patient is HIV positive
- Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- Patient has a history of neoplastic disease
- Patient has a history of alcohol or drug abuse within the past 3 years
- Patient has viral hepatitis (hepatitis B or C)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086502
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00086502 |
Other Study ID Numbers: |
0431-019 Formally-A0604T2DPT 2006_410 |
First Posted: | July 5, 2004 Key Record Dates |
Results First Posted: | April 19, 2010 |
Last Update Posted: | February 5, 2016 |
Last Verified: | February 2016 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Pioglitazone Sitagliptin Phosphate Hypoglycemic Agents |
Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |