Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00086515 |
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Recruitment Status :
Completed
First Posted : July 5, 2004
Results First Posted : December 17, 2010
Last Update Posted : May 5, 2017
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Diabetes Mellitus, Type II |
| Interventions |
Drug: Sitagliptin (MK0431) Drug: Placebo/Glipizide 5 mg Drug: Metformin Drug: Pioglitazone |
| Enrollment | 701 |
Participant Flow
| Recruitment Details | Primary therapy Period: 13-Jul-2004 through 02-Feb-2007 (for the 2-year Phase A and B periods); 100 study centers worldwide. (46 sites in the United States, 25 sites in 11 countries in Europe, and 29 sites in 13 countries in the rest of the world). |
| Pre-assignment Details | Patients 18-78 years of age with type 2 diabetes mellitus with inadequate glycemic control (hemoglobin A1C [A1C] ≥7% and ≤10%) on stable doses of metformin (≥1500 mg/day) were eligible to enter the 104-week study. |
| Arm/Group Title | Sitagliptin 100 mg | Placebo / Glipizide 5 mg |
|---|---|---|
 Arm/Group Description |
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. |
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. |
| Period Title: Phase A (Weeks 0-24) | ||
| Started | 464 | 237 |
| Completed | 415 | 192 |
| Not Completed | 49 | 45 |
| Reason Not Completed | ||
| Adverse Event | 17 | 9 |
| Lack of Efficacy | 7 | 13 |
| Lost to Follow-up | 4 | 5 |
| Protocol Violation | 3 | 1 |
| Withdrawal by Subject | 10 | 10 |
| Patient Moved | 2 | 3 |
| Protocol-Spec lab discon criteria | 4 | 3 |
| Poor compliance | 1 | 0 |
| Patient needed prohibited treatment | 0 | 1 |
| Personal Circumstance | 1 | 0 |
| Period Title: Phase A to Phase B Transition Period | ||
| Started | 415 | 192 |
| Completed | 391 | 164 |
| Not Completed | 24 | 28 |
| Reason Not Completed | ||
| Adverse Event | 2 | 1 |
| Lack of Efficacy | 2 | 2 |
| Withdrawal by Subject | 1 | 0 |
| Protocol Violation | 0 | 1 |
| Patient received Phase A rescue therapy | 16 | 23 |
| Protocol-Spec lab discon criteria | 1 | 1 |
| Poor compliance | 1 | 0 |
| Patient needed prohibited treatment | 1 | 0 |
| Period Title: Phase B (Weeks 24-104) | ||
| Started | 391 | 164 |
| Completed | 201 | 109 |
| Not Completed | 190 | 55 |
| Reason Not Completed | ||
| Adverse Event | 16 | 10 |
| Lack of Efficacy | 94 | 19 |
| Lost to Follow-up | 13 | 4 |
| Physician Decision | 3 | 0 |
| Protocol Violation | 1 | 0 |
| Withdrawal by Subject | 15 | 5 |
| Patient Moved | 2 | 2 |
| Protocol-Specific discontinuation | 5 | 3 |
| Protocol-Specific lab discon criteria | 36 | 10 |
| Patient Died | 3 | 1 |
| Patient needed prohibited treatment | 0 | 1 |
| Personal Circumstance | 1 | 0 |
| Discontinued in error | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Sitagliptin 100 mg | Placebo / Glipizide 5 mg | Total | |
|---|---|---|---|---|
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Arm/Group Description |
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. |
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. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 464 | 237 | 701 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 464 participants | 237 participants | 701 participants | |
| 54.4 (10.4) | 54.7 (9.7) | 54.5 (10.2) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 464 participants | 237 participants | 701 participants | |
| Female |
205 44.2%
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96 40.5%
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301 42.9%
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| Male |
259 55.8%
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141 59.5%
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400 57.1%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 464 participants | 237 participants | 701 participants |
| White | 293 | 159 | 452 | |
| Black | 31 | 14 | 45 | |
| Hispanic | 72 | 28 | 100 | |
| Asian | 49 | 26 | 75 | |
| Other | 19 | 10 | 29 | |
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Fasting Plasma Glucose (FPG)
Mean (Standard Deviation) Unit of measure: mg/dL |
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| Number Analyzed | 464 participants | 237 participants | 701 participants | |
| 170.2 (40.2) | 174.1 (42.0) | 171.5 (41.3) | ||
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Hemoglobin A1C (A1C)
Mean (Standard Deviation) Unit of measure: Percent |
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| Number Analyzed | 464 participants | 237 participants | 701 participants | |
| 8.0 (0.8) | 8.0 (0.8) | 8.0 (0.8) | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title: | Senior Vice President, Global Clinical Development |
| Organization: | Merck Sharp & Dohme Corp |
| Phone: | 1-800-672-6372 |
| EMail: | ClinicalTrialsDisclosure@merck.com |
Publications:
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT00086515 |
| Other Study ID Numbers: |
0431-020 Formally-B0604T2DMT 2006_411 |
| First Submitted: | July 2, 2004 |
| First Posted: | July 5, 2004 |
| Results First Submitted: | November 19, 2010 |
| Results First Posted: | December 17, 2010 |
| Last Update Posted: | May 5, 2017 |