Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00086515 |
Recruitment Status :
Completed
First Posted : July 5, 2004
Results First Posted : December 17, 2010
Last Update Posted : May 5, 2017
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type II | Drug: Sitagliptin (MK0431) Drug: Placebo/Glipizide 5 mg Drug: Metformin Drug: Pioglitazone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 701 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 Metformin Therapy |
Actual Study Start Date : | June 30, 2004 |
Actual Primary Completion Date : | July 20, 2005 |
Actual Study Completion Date : | February 2, 2007 |

Arm | Intervention/treatment |
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Experimental: Sitagliptin 100 mg
The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
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Drug: Sitagliptin (MK0431)
Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
Other Names:
Drug: Metformin Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104) Drug: Pioglitazone Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)
Other Name: ACTOS |
Placebo Comparator: Placebo / Glipizide 5 mg
The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.
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Drug: Placebo/Glipizide 5 mg
Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104) Drug: Metformin Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104) Drug: Pioglitazone Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)
Other Name: ACTOS |
- Change From Baseline in Hemoglobin A1C (A1C) at Week 24 [ Time Frame: Baseline and Week 24 ]
A1C is measured as a percent. Thus, this change from
baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ]
Change from baseline at Week 24 is defined as FPG at
Week 24 minus FPG at Week 0.
- Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 [ Time Frame: Baseline and Week 24 ]Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 78 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with type 2 diabetes mellitus

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): NCT00086515
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |

Publications:
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00086515 |
Other Study ID Numbers: |
0431-020 Formally-B0604T2DMT 2006_411 |
First Posted: | July 5, 2004 Key Record Dates |
Results First Posted: | December 17, 2010 |
Last Update Posted: | May 5, 2017 |
Last Verified: | March 2017 |
Type 2 Diabetes Mellitus |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Pioglitazone Sitagliptin Phosphate Glipizide |
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 |