A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)

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ClinicalTrials.gov Identifier: NCT01217073

Recruitment Status : Completed

First Posted : October 8, 2010

Results First Posted : October 29, 2015

Last Update Posted : June 29, 2017

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: Omarigliptin Drug: Placebo to omarigliptin Drug: Pioglitazone Drug: Metformin Drug: Placebo to metformin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Omarigliptin 0.25 mg (Base)	Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
Omarigliptin 1 mg (Base)	Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
Omarigliptin 3 mg (Base)	Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
Omarigliptin 10 mg (Base)	Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
Omarigliptin 25 mg (Base)	Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
Placebo (Base)	Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Pooled Omarigliptin (Extension)	Participants received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (extension period)
Placebo/Metformin (Extension)	Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day

Participant Flow for 2 periods

Period 1: Base Period

	Omarigliptin 0.25 mg (Base)	Omarigliptin 1 mg (Base)	Omarigliptin 3 mg (Base)	Omarigliptin 10 mg (Base)	Omarigliptin 25 mg (Base)	Placebo (Base)
STARTED	113	115	114	115	114	114
COMPLETED	106	110	107	113	99	105
NOT COMPLETED	7	5	7	2	15	9
Adverse Event	1	0	1	0	4	1
Alanine aminotransferase (ALT)/AST	1	0	0	0	0	0
Excluded medication	0	0	0	0	1	0
Lack of Efficacy	0	0	0	0	0	1
Lost to Follow-up	0	0	1	1	3	0
Physician Decision	0	0	0	0	1	0
Protocol Violation	1	0	0	0	1	2
Withdrawal by Subject	4	5	5	1	5	5

Period 2: Extension Period

	Pooled Omarigliptin (Extension)	Placebo/Metformin (Extension)
STARTED	405	80
COMPLETED	314	60
NOT COMPLETED	91	20
Adverse Event	19	5
ALT/AST	2	0
Contraindication to study medication	1	0
Creatinine/eGFR	11	1
Death	1	0
Excluded medication	2	0
Lack of Efficacy	3	0
Lost to Follow-up	9	1
Non-compliance with study drug	0	1
Physician Decision	4	1
Protocol Violation	2	1
Site discontinued study participation	7	2
Withdrawal by Subject	30	8

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Population includes all participants randomized during the base period. The extension period only included participants who completed the base period and consented to enter the extension period.

Reporting Groups

	Description
Omarigliptin 0.25 mg (Base)	Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
Omarigliptin 1 mg (Base)	Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
Omarigliptin 3 mg (Base)	Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
Omarigliptin 10 mg (Base)	Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
Omarigliptin 25 mg (Base)	Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
Placebo (Base)	Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Total	Total of all reporting groups

Baseline Measures

Omarigliptin 0.25 mg (Base)

Omarigliptin 1 mg (Base)

Omarigliptin 3 mg (Base)

Omarigliptin 10 mg (Base)

Omarigliptin 25 mg (Base)

Placebo (Base)

Total

Overall Participants Analyzed
[Units: Participants]

113

115

114

115

114

685

Age
[Units: Years]
Mean (Standard Deviation)

54.3 (8.9)

55.7 (8.5)

55.3 (8.5)

54.4 (10.0)

55.1 (8.5)

55.9 (8.4)

55.1 (8.8)

Sex: Female, Male
[Units: Participants]
Count of Participants

Female

48 42.5%

48 41.7%

49 43.0%

59 51.3%

45 39.5%

49 43.0%

298 43.5%

Male

65 57.5%

67 58.3%

65 57.0%

56 48.7%

69 60.5%

65 57.0%

387 56.5%

Hemoglobin A1c (A1C) ^[1]
[Units: Percent]
Mean (Standard Deviation)

8.1 (0.9)

8.0 (0.9)

7.9 (0.9)

8.0 (0.9)

8.1 (1.0)

8.1 (0.9)

^[1]	Participants with data: Omariglptin 0.25 mg, n=113; Omariglptin 1 mg, n=115; Omariglptin 3 mg, n=114; Omariglptin 10 mg, n=115; Omariglptin 25 mg, n=113; Placebo, n=113; Total, n=683

2-hour post meal glucose (2-hr PMG) ^[1]
[Units: mg/dL]
Mean (Standard Deviation)

229.4 (63.7)

229.3 (64.5)

234.7 (81.7)

231.6 (72.3)

245.3 (82.7)

241.4 (72.2)

235.2 (73.2)

^[1]	Participants with data: Omariglptin 0.25 mg, n=111; Omariglptin 1 mg, n=113; Omariglptin 3 mg, n=113; Omariglptin 10 mg, n=112; Omariglptin 25 mg, n=111; Placebo, n=110; Total, n=670

Fasting plasma glucose (FPG) ^[1]
[Units: mg/dL]
Mean (Standard Deviation)

170.3 (45.3)

169.4 (42.4)

169.0 (42.6)

166.8 (37.6)

173.9 (47.6)

171.9 (42.8)

170.2 (43.0)

^[1]	Participants with data: Omariglptin 0.25 mg, n=113; Omariglptin 1 mg, n=115; Omariglptin 3 mg, n=114; Omariglptin 10 mg, n=115; Omariglptin 25 mg, n=114; Placebo, n=113; Total, n=684

Outcome Measures

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1. Primary:

Change From Baseline in Plasma A1C Levels at Week 12 [ Time Frame: Baseline (Week 0) and Week 12 ]

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2. Primary:

Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period [ Time Frame: Up to 16 weeks (including 28 days following the last dose of study drug) ]

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3. Primary:

Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period [ Time Frame: Up to 12 weeks ]

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4. Primary:

Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period [ Time Frame: Up to 70 Weeks (Weeks 12 to 78 plus 4-week follow-up period) ]

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5. Primary:

Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period [ Time Frame: Up to 66 weeks (Weeks 12 to 78) ]

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6. Secondary:

Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12 [ Time Frame: Baseline (Week 0) and Week 12 ]

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7. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12 [ Time Frame: Baseline (Week 0) and Week 12 ]

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8. Secondary:

Mean Plasma A1C Level at Baseline of the Extension Period [ Time Frame: Baseline (Week 0) ]

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9. Secondary:

Change From Baseline in Plasma A1C Levels at Week 78 [ Time Frame: Baseline (Week 0) and Week 78 ]

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10. Secondary:

Mean 2h-PMG Level at Baseline of the Extension Period [ Time Frame: Baseline (Week 0) ]

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11. Secondary:

Change From Baseline in 2h-PMG at Week 78 [ Time Frame: Baseline (Week 0) and Week 78 ]

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12. Secondary:

Mean FPG Level at Baseline of the Extension Period [ Time Frame: Baseline (Week 0) ]

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13. Secondary:

Change From Baseline in FPG Levels at Week 78 [ Time Frame: Baseline (Week 0) and Week 78 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.

Results Point of Contact:

Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

Publications of Results:

Sheu WH, Gantz I, Chen M, Suryawanshi S, Mirza A, Goldstein BJ, Kaufman KD, Engel SS. Safety and Efficacy of Omarigliptin (MK-3102), a Novel Once-Weekly DPP-4 Inhibitor for the Treatment of Patients With Type 2 Diabetes. Diabetes Care. 2015 Nov;38(11):2106-14. doi: 10.2337/dc15-0109. Epub 2015 Aug 26.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01217073 History of Changes
Other Study ID Numbers:	3102-006 2010-022193-13 ( EudraCT Number ) 2011-000656-42 ( EudraCT Number )
First Submitted:	October 6, 2010
First Posted:	October 8, 2010
Results First Submitted:	September 29, 2015
Results First Posted:	October 29, 2015
Last Update Posted:	June 29, 2017

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