Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
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| ClinicalTrials.gov Identifier: NCT00875394 |
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Recruitment Status :
Completed
First Posted : April 3, 2009
Results First Posted : April 20, 2011
Last Update Posted : May 30, 2017
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Diabetes Mellitus, Non-Insulin-Dependent |
| Interventions |
Drug: sitagliptin phosphate Drug: Comparator: metformin Drug: Comparator: Antidiabetic Standard of Care |
| Enrollment | 68 |
Participant Flow
| Recruitment Details |
Patients were recruited in Principal Investigator's private practice, in Mexico City. First Patient Entered: 15 Feb 2007. Last Patient's Last Visit: 27 Jun 2008 |
| Pre-assignment Details | Patients 30 to 78 years of age with inadequate glycemic control (Glycosylated hemoglobin A1C (A1C) 6.5 to 11%) on diet/exercise and metformin dosed at ≥1500 mg per day patients were to receive either sitagliptin added to ongoing metformin or "standard care" added to ongoing metformin. |
| Arm/Group Title | Sitagliptin + Metformin | Metformin + Any Non-DPP-4i Oral Antidiabetic Drug | Metformin Alone |
|---|---|---|---|
 Arm/Group Description |
Patients administered sitagliptin and metformin | Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care". | Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care". |
| Period Title: Overall Study | |||
| Started | 36 | 23 | 9 |
| Completed | 36 | 23 | 9 |
| Not Completed | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Sitagliptin + Metformin | Metformin + Any Non-DPP-4i Oral Antidiabetic Drug | Metformin Alone | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Patients administered sitagliptin and metformin | Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care". | Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care". | Total of all reporting groups | |
| Overall Number of Baseline Participants | 36 | 23 | 9 | 68 | |
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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 | 36 participants | 23 participants | 9 participants | 68 participants | |
| 54.2 (9.8) | 56.0 (8.5) | 53.3 (11.7) | 54.69 (9.55) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 36 participants | 23 participants | 9 participants | 68 participants | |
| Female |
25 69.4%
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19 82.6%
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6 66.7%
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50 73.5%
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| Male |
11 30.6%
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4 17.4%
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3 33.3%
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18 26.5%
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Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m2 |
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| Number Analyzed | 36 participants | 23 participants | 9 participants | 68 participants | |
| 29.0 (4.5) | 28.8 (5.1) | 28.3 (5.2) | 28.84 (4.74) | ||
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Glycosylated Hemoglobin A1C (A1C)
Mean (Standard Deviation) Unit of measure: Percent |
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| Number Analyzed | 36 participants | 23 participants | 9 participants | 68 participants | |
| 8.8 (1.5) | 8.0 (1.8) | 8.2 (1.1) | 8.47 (1.61) | ||
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Time since diagnosis of diabetes
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 36 participants | 23 participants | 9 participants | 68 participants | |
| 8.9 (7.1) | 6.8 (8.5) | 10.9 (7.7) | 8.43 (7.68) | ||
Outcome Measures
Adverse Events
Limitations and Caveats
A limited number of participants were recruited into this open-label study. This study was conducted at a single site.
Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.
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 |
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00875394 |
| Other Study ID Numbers: |
0431-189 2009_571 |
| First Submitted: | April 1, 2009 |
| First Posted: | April 3, 2009 |
| Results First Submitted: | June 12, 2009 |
| Results First Posted: | April 20, 2011 |
| Last Update Posted: | May 30, 2017 |