March 18, 2013
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March 20, 2013
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June 7, 2016
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July 18, 2016
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November 20, 2017
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May 3, 2013
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September 14, 2015 (Final data collection date for primary outcome measure)
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- Change From Baseline in A1C at Week 24 [ Time Frame: Baseline and Week 24 ]
A1C (%) is used to report average blood glucose levels over prolonged periods of time.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study.
- Percentage of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Up to Week 27 ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.
The safety database was analyzed in a standard fashion in the all participants as treated (APaT) population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above).
- Percentage of Participants Who Discontinued Study Drug Due to an AE [ Time Frame: Up to Week 24 ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.
The safety database was analyzed in a standard fashion in the APaT population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above).
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- Change From Baseline in A1C at Week 24 [ Time Frame: Baseline and Week 24 ]
- Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to Week 27 ]
- Percentage of Participants Who Discontinued from the Study Due to an Adverse Event [ Time Frame: Up to Week 24 ]
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Complete list of historical versions of study NCT01814748 on ClinicalTrials.gov Archive Site
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- Change From Baseline in 2-hr PMG at Week 24 [ Time Frame: Baseline and Week 24 ]
Blood glucose was measured 120 minutes from start of meal.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study.
- Change in Baseline in FPG at Week 24 [ Time Frame: Baseline and Week 24 ]
Blood glucose was measured on a fasting basis.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study.
- Percentage of Participants Attaining A1C Glycemic Goals of <7.0% at Week 24 [ Time Frame: Week 24 ]
Percentage of participants was estimated using standard multiple imputation techniques (constrained longitudinal data analysis [cLDA] model). Within-group confidence intervals (CIs) were calculated via the Wilson score method.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study.
- Percentage of Participants Attaining A1C Glycemic Goals of <6.5% (48 mmol/Mol) at Week 24 [ Time Frame: Week 24 ]
Percentage of participants was estimated using standard multiple imputation techniques (cLDA). Within-group CIs were calculated via the Wilson score method.
The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study.
- Percentage of Participants Who Required Glycemic Rescue by Week 24 [ Time Frame: Up to Week 24 ]
Participants exceeding pre-specified glycemic thresholds after starting the double-blind treatment period may have received rescue therapy (per protocol) with open-label metformin initiated by the investigator.
This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above).
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- Change from Baseline in 2-hour Post-Meal Glucose (PMG) at Week 24 [ Time Frame: Baseline and Week 24 ]
- Change in Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ]
- Number of Participants Attaining A1C Glycemic Goals of <7.0% and <6.5% at Week 24 [ Time Frame: Week 24 ]
- Time to Participant Rescue with Open-label Metformin for Participants Exceeding Pre-specified Glycemic Thresholds [ Time Frame: Up to Week 24 ]
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Not Provided
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Not Provided
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A Study of the Safety and Efficacy of Omarigliptin (MK-3102) in ≥18 and <45 Year-Old Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028) |
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control |
This study will examine the safety and efficacy of once-weekly omarigliptin in participants 18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The study hypothesis is that treatment with omarigliptin compared with placebo provides greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks. |
Not Provided |
Interventional |
Phase 3 |
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
Diabetes Mellitus |
- Drug: Omarigliptin
Omarigliptin 25 mg capsule administered orally once weekly
Other Name: MK-3102
- Drug: Placebo to omarigliptin
Matching placebo to omarigliptin 25 mg capsule administered orally once weekly
- Drug: Metformin
Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
Other Names:
- Fortamet®
- Glucophage®
- Glucophage® XR
- Glumetza®
- Riomet®
- Metgluco®
- Glycoran®
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- Experimental: Omarigliptin 25 mg
Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
Interventions:
- Drug: Omarigliptin
- Drug: Metformin
- Placebo Comparator: Placebo
Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
Interventions:
- Drug: Placebo to omarigliptin
- Drug: Metformin
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Gantz I, Sokolova L, Jain L, Iredale C, O'Neill EA, Wei Z, Lam R, Suryawanshi S, Kaufman KD, Engel SS, Lai E. Use of Prohibited Medication, a Potentially Overlooked Confounder in Clinical Trials: Omarigliptin (Once-weekly DPP-4 Inhibitor) Monotherapy Trial in 18- to 45-year-olds. Clin Ther. 2017 Oct;39(10):2024-2037. doi: 10.1016/j.clinthera.2017.08.009. Epub 2017 Sep 18. |
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Completed |
203 |
200 |
September 14, 2015 |
September 14, 2015 (Final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
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Sexes Eligible for Study: |
All |
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18 Years to 44 Years (Adult) |
No |
Contact information is only displayed when the study is recruiting subjects |
Not Provided |
Mexico, Romania, Russian Federation, Serbia, South Africa, Ukraine, United States |
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NCT01814748 |
3102-028 2012-004303-12 ( EudraCT Number ) |
Yes |
Not Provided |
Not Provided |
Merck Sharp & Dohme Corp. |
Merck Sharp & Dohme Corp. |
Not Provided |
Study Director: |
Medical Director |
Merck Sharp & Dohme Corp. |
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Merck Sharp & Dohme Corp. |
October 2017 |