The purpose of this study is to assess the hypothesis that treatment with study medication (omarigliptin; MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5 different doses of omarigliptin to identify which dose is the most effective in the treatment of type 2 diabetes.
MK-3102-006-Ext 1 added a 66-week extension to the base study (MK-3102 P006) to assess the long-term safety and tolerability of omarigliptin. To be eligible for the extension, participants must complete the double-blind base study, must have had at least a 75% compliance with study drug during the base study and can not meet any of the criteria for discontinuation. Participants randomized to placebo in the base study will be switched in a blinded manner to pioglitazone 30 mg once daily, in the extension study prior to implementation of amendment P006-13. Once amendment P006-13 has been IRB/IEC approved and blinded metformin drug supply is available at the site, participants will be switched from pioglitazone to metformin, starting at 500 mg once daily and titrated up to 1000 mg twice daily. Participants with a contraindication to metformin will be discontinued from the study. Participants randomized to 0.25 mg, 1 mg, 3 mg, and 10 mg of omarigliptin in the base study will be switched to omarigliptin 25 mg; those randomized to 25 mg of omarigliptin in the base study will continue on the same dose in the extension study. After the clinical dose of omarigliptin selected for further development has been identified based upon the results of the base study, all participants randomized to omarigliptin will be switched to the identified clinical dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
685
Omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For omarigliptin 3 mg, participants received two omarigliptin 1.5 mg capsules.
Matching placebo to omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For matching placebo to omarigliptin 3 mg, participants received two matching placebo to omarigliptin 1.5 mg capsules.
Pioglitazone 15 mg oral tablet or capsule administered once daily
Change From Baseline in Plasma A1C Levels at Week 12
A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level.
Time frame: Baseline (Week 0) and Week 12
Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.
Time frame: Up to 16 weeks (including 28 days following the last dose of study drug)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.
Time frame: Up to 12 weeks
Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.
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Metformin 500 mg oral tablet administered once or twice daily
Matching placebo to metformin oral tablet administered once daily
Time frame: Up to 70 Weeks (Weeks 12 to 78 plus 4-week follow-up period)
Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.
Time frame: Up to 66 weeks (Weeks 12 to 78)
Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12
Change from baseline was calculated by subtracting the baseline level from the Week 12 level.
Time frame: Baseline (Week 0) and Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12
Change from baseline was calculated by subtracting the baseline level from the Week 12 level.
Time frame: Baseline (Week 0) and Week 12
Mean Plasma A1C Level at Baseline of the Extension Period
A1C levels were measured as a percent at baseline (Week 0) for participants who entered the extension period.
Time frame: Baseline (Week 0)
Change From Baseline in Plasma A1C Levels at Week 78
A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 78 level.
Time frame: Baseline (Week 0) and Week 78
Mean 2h-PMG Level at Baseline of the Extension Period
Plasma 2h-PMG levels were measured at baseline (Week 0) for participants who entered the extension period.
Time frame: Baseline (Week 0)
Change From Baseline in 2h-PMG at Week 78
Change from baseline was calculated by subtracting the baseline level from the Week 78 level.
Time frame: Baseline (Week 0) and Week 78
Mean FPG Level at Baseline of the Extension Period
Plasma FPG levels were measured at baseline (Week 0) for particiapnts who entered the extension period.
Time frame: Baseline (Week 0)
Change From Baseline in FPG Levels at Week 78
Change from baseline was calculated by subtracting the baseline level from the Week 78 level.
Time frame: Baseline (Week 0) and Week 78