Type 2 Diabetes MellitusPhase 2NCT01217073

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

A Phase 2 study testing Omarigliptin, Pioglitazone and Metformin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Omarigliptin, Pioglitazone and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 685 participants
Where: No sites listed yet
Study dates: 8 Oct 2010to 1 Apr 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.
The participant:
Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age;
Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; for Japan: BMI >18 kg/m^2 and <43 kg/m^2;
Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control;
Is a male, or a female who is highly unlikely to conceive.

Who cannot join

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.
The participant:
Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
Is on a weight loss program or has started a weight loss medication within the prior 8 weeks;
Has required insulin therapy within 14 weeks prior to signing informed consent;
Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease;

Show all 9Show fewer

Has congestive heart failure or has new or worsening signs or symptoms of coronary heart disease;
Had any of the following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder;
Has a history of malignancy or clinically important hematological disorder

About this study

Official title: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

Read the detailed description

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.

Conditions: Type 2 Diabetes Mellitus
Being tested: Omarigliptin, Placebo to omarigliptin, Pioglitazone, Metformin, Placebo to metformin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OmarigliptinDrug
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.
Placebo to omarigliptinDrug
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.
PioglitazoneDrug
Pioglitazone 15 mg oral tablet or capsule administered once daily
MetforminDrug
Metformin 500 mg oral tablet administered once or twice daily
Placebo to metforminDrug
Matching placebo to metformin oral tablet administered once daily

Study groups in NCT01217073
Study group	Role	What they receive
Omarigliptin 0.25 mg (Base)	Experimental	Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) Receives: Drug: Omarigliptin
Omarigliptin 1 mg (Base)	Experimental	Omarigliptin 1 mg administered once weekly for 12 weeks (Base) Receives: Drug: Omarigliptin
Omarigliptin 3 mg (Base)	Experimental	Omarigliptin 3 mg administered once weekly for 12 weeks (Base) Receives: Drug: Omarigliptin
Omarigliptin 10 mg (Base)	Experimental	Omarigliptin 10 mg administered once weekly for 12 weeks (Base) Receives: Drug: Omarigliptin
Omarigliptin 25 mg (Base)	Experimental	Omarigliptin 25 mg administered once weekly for 12 weeks (Base) Receives: Drug: Omarigliptin
Placebo (Base)	Placebo comparator	Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) Receives: Drug: Placebo to omarigliptin
Pooled omarigliptin (Extension)	Experimental	Participants who received omarigliptin during the base study, received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (Extension). Receives: Drug: Omarigliptin; Drug: Placebo to metformin
Placebo/Metformin	Active comparator	Participants who received matching placebo to omarigliptin during the base period, received pioglitazone administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (extension period). Note: A protocol amendment removed pioglitazone during the extension period. Participants discontinued pioglitazone and switched to blinded metformin. Participants who were previously rescued with open-label metformin during the base period continued in the extension period on open-label metformin. Receives: Drug: Placebo to omarigliptin; Drug: Pioglitazone; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 66 weeks (Weeks 12 to 78)

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0) and Week 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 20101 Apr 2013

First posted8 Oct 2010 (estimated)
Study start8 Oct 2010
Primary completion3 Jan 2012
Study completion1 Apr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 685 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01217073
Sponsor's protocol ID: 3102-006
Other IDs: 2010-022193-13, 2011-000656-42
Status last verified: Aug 2018
First submitted: 6 Oct 2010
Last updated: 10 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

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.
PubMed 26310692

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT01217073
Acronym / sponsor ID: 3102-006
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 685 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 8 Oct 2010 (actual)
Primary completion: 3 Jan 2012 (actual)
Study completion: 1 Apr 2013 (actual)
First posted: 8 Oct 2010 (estimated)
Results: Posted 29 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Omarigliptin 0.25 mg (Base)	Experimental	Drug: OmarigliptinOmarigliptin 0.25 mg administered once weekly for 12 weeks (Base)
Omarigliptin 1 mg (Base)	Experimental	Drug: OmarigliptinOmarigliptin 1 mg administered once weekly for 12 weeks (Base)
Omarigliptin 3 mg (Base)	Experimental	Drug: OmarigliptinOmarigliptin 3 mg administered once weekly for 12 weeks (Base)
Omarigliptin 10 mg (Base)	Experimental	Drug: OmarigliptinOmarigliptin 10 mg administered once weekly for 12 weeks (Base)
Omarigliptin 25 mg (Base)	Experimental	Drug: OmarigliptinOmarigliptin 25 mg administered once weekly for 12 weeks (Base)
Placebo (Base)	Placebo comparator	Drug: Placebo to omarigliptinMatching placebo to omarigliptin administered once weekly for 12 weeks (Base)
Pooled omarigliptin (Extension)	Experimental	Drug: Omarigliptin, Drug: Placebo to metforminParticipants who received omarigliptin during the base study, received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (Extension).
Placebo/Metformin	Active comparator	Drug: Placebo to omarigliptin, Drug: Pioglitazone, Drug: MetforminParticipants who received matching placebo to omarigliptin during the base period, received pioglitazone administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (extension period). Note: A protocol amendment removed pioglitazone during the extension period. Participants discontinued pioglitazone and switched to blinded metformin. Participants who were previously rescued with open-label metformin during the base period continued in the extension period on open-label metformin.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.
Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age;
Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; for Japan: BMI >18 kg/m^2 and <43 kg/m^2;
Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control;
Is a male, or a female who is highly unlikely to conceive.

Key exclusion criteria (9 listed)

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.
Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
Is on a weight loss program or has started a weight loss medication within the prior 8 weeks;
Has required insulin therapy within 14 weeks prior to signing informed consent;
Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OmarigliptinOmarigliptin 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.	Drug	Omarigliptin 0.25 mg (Base), Omarigliptin 1 mg (Base), Omarigliptin 10 mg (Base), Omarigliptin 25 mg (Base), Omarigliptin 3 mg (Base), Pooled omarigliptin (Extension)
Placebo to omarigliptinMatching 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.	Drug	Placebo (Base), Placebo/Metformin
PioglitazonePioglitazone 15 mg oral tablet or capsule administered once daily	Drug	Placebo/Metformin
MetforminMetformin 500 mg oral tablet administered once or twice daily	Drug	Placebo/Metformin
Placebo to metforminMatching placebo to metformin oral tablet administered once daily	Drug	Pooled omarigliptin (Extension)

Primary outcome

Change From Baseline in Plasma A1C Levels at Week 12
Time frame: Baseline (Week 0) and Week 12
A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level.
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)
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.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period
Time frame: Up to 12 weeks
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.
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)
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.
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)
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.

8 secondary outcomes

Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12
Time frame: Baseline (Week 0) and Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12
Time frame: Baseline (Week 0) and Week 12
Mean Plasma A1C Level at Baseline of the Extension Period
Time frame: Baseline (Week 0)
Change From Baseline in Plasma A1C Levels at Week 78
Time frame: Baseline (Week 0) and Week 78
Mean 2h-PMG Level at Baseline of the Extension Period
Time frame: Baseline (Week 0)
Change From Baseline in 2h-PMG at Week 78
Time frame: Baseline (Week 0) and Week 78
Mean FPG Level at Baseline of the Extension Period
Time frame: Baseline (Week 0)
Change From Baseline in FPG Levels at Week 78
Time frame: Baseline (Week 0) and Week 78

Results and safety

Results posted to the registry on 29 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omarigliptin 0.25 mg (Base)	113	106
Omarigliptin 1 mg (Base)	115	110
Omarigliptin 3 mg (Base)	114	107
Omarigliptin 10 mg (Base)	115	113
Omarigliptin 25 mg (Base)	114	99
Placebo (Base)	114	105
Pooled Omarigliptin (Extension)	0	0
Placebo/Metformin (Extension)	0	0

Primary outcome: Change From Baseline in Plasma A1C Levels at Week 12

Time frame: Baseline (Week 0) and Week 12. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Omarigliptin 0.25 mg (Base) n = 113	Omarigliptin 1 mg (Base) n = 115	Omarigliptin 3 mg (Base) n = 114	Omarigliptin 10 mg (Base) n = 115	Omarigliptin 25 mg (Base) n = 114	Placebo (Base) n = 113
Value	-0.14 (-0.30 to 0.01)	-0.36 (-0.51 to -0.20)	-0.35 (-0.50 to -0.19)	-0.53 (-0.68 to -0.38)	-0.57 (-0.73 to -0.42)	0.14 (-0.01 to 0.29)

Omarigliptin 25 mg (Base) vs Placebo (Base): Difference in least squares mean: -0.71 (95% CI -0.93 to -0.50), p <0.001, Constrained longitudinal data analysis
Omarigliptin 10 mg (Base) vs Placebo (Base): Difference in least squares mean: -0.67 (95% CI -0.88 to -0.45), p <0.001, Constrained longitudinal data analysis
Omarigliptin 3 mg (Base) vs Placebo (Base): Difference in least squares mean: -0.49 (95% CI -0.70 to -0.27), p <0.001, Constrained longitudinal data analysis

Population analysed: Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.

Primary outcome: 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). Number. Unit: Percentage of participants

Measure	Omarigliptin 0.25 mg (Base) n = 113	Omarigliptin 1 mg (Base) n = 115	Omarigliptin 3 mg (Base) n = 114	Omarigliptin 10 mg (Base) n = 115	Omarigliptin 25 mg (Base) n = 114	Placebo (Base) n = 113
Value	37.2	43.5	36.8	36.5	33.3	31.0

Omarigliptin 0.25 mg (Base) vs Placebo (Base): Difference in percentage: 6.2 (95% CI -6.2 to 18.4)
Omarigliptin 1 mg (Base) vs Placebo (Base): Difference in percentage: 12.5 (95% CI -0.1 to 24.7)
Omarigliptin 3 mg (Base) vs Placebo (Base): Difference in percentage: 5.9 (95% CI -6.5 to 18.0)

Population analysed: The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.

Primary outcome: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period

Time frame: Up to 12 weeks. Number. Unit: Percentage of participants

Measure	Omarigliptin 0.25 mg (Base) n = 113	Omarigliptin 1 mg (Base) n = 115	Omarigliptin 3 mg (Base) n = 114	Omarigliptin 10 mg (Base) n = 115	Omarigliptin 25 mg (Base) n = 114	Placebo (Base) n = 113
Value	0.9	0	0.9	0	3.5	0.9

Omarigliptin 0.25 mg (Base) vs Placebo (Base): Difference in percentage: 0.0 (95% CI -4.1 to 4.1)
Omarigliptin 1 mg (Base) vs Placebo (Base): Difference in percentage: -0.9 (95% CI -4.9 to 2.4)
Omarigliptin 3 mg (Base) vs Placebo (Base): Difference in percentage: 0.0 (95% CI -4.1 to 4.0)

Primary outcome: 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). Number. Unit: Percentage of participants

Measure	Pooled Omarigliptin (Extension) n = 392	Placebo/Metformin (Extension) n = 76
Value	66.8	65.8

Pooled Omarigliptin (Extension) vs Placebo/Metformin (Extension): Difference in percent: 1.0 (95% CI -9.8 to 13.1)

Population analysed: Analysis population defined as all randomized participamts who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 82 weeks (including 28 days following the last dose of study drug). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omarigliptin 0.25 mg (Base)	0 of 113 (0%)	6 of 113 (5.3%)	Not reported
Omarigliptin 1 mg (Base)	1 of 115 (0.9%)	7 of 115 (6.1%)	Not reported
Omarigliptin 3 mg (Base)	0 of 114 (0%)	4 of 114 (3.5%)	Not reported
Omarigliptin 10 mg (Base)	2 of 115 (1.7%)	5 of 115 (4.3%)	Not reported
Omarigliptin 25 mg (Base)	3 of 114 (2.6%)	7 of 114 (6.1%)	Not reported
Placebo (Base)	0 of 113 (0%)	6 of 113 (5.3%)	Not reported
Pooled Omarigliptin (Extension)	28 of 405 (6.9%)	76 of 392 (19.4%)	Not reported
Placebo/Metformin (Extension)	3 of 80 (3.8%)	10 of 76 (13.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26310692Sheu 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.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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Obesity
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Type 2 Diabetes (T2DM), Endothelial Dysfunction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omarigliptin, Pioglitazone and Metformin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Plasma A1C Levels at Week 12 (time frame: Baseline (Week 0) and Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01217073, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.