Type 2 Diabetes MellitusPhase 3NCT01682759

A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

A Phase 3 study testing Omarigliptin, Glimepiride 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

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Omarigliptin, Glimepiride and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 751 participants
Where: No sites listed yet
Study dates: 10 Sep 2012to 26 Jan 2015
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with Type 2 diabetes mellitus
On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control
Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control

Who cannot join

History of type 1 diabetes mellitus or a history of ketoacidosis
Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent
On a weight loss program and is not in the maintenance phase or has
started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
Medical history of active liver disease (other than non-alcoholic
hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease

Show all 14Show fewer

Human immunodeficiency virus
New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke or transient ischemic neurological disorder within the past 3 months
History of malignancy ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer, or in situ
cervical cancer
Clinically important hematological disorder (such as aplastic anemia,
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
Pregnant or breast-feeding, or is expecting to conceive or donate eggs
during the trial, including 21 days following the last dose of study drug

About this study

Official title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.

Conditions: Type 2 Diabetes Mellitus
Being tested: Omarigliptin, Placebo to Omarigliptin, Glimepiride, Glimepiride Placebo, Metformin
Keywords: diabetes
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

OmarigliptinDrug
Placebo to OmarigliptinDrug
GlimepirideDrug
Also called AMARYL®, GLIMY
Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.
Glimepiride PlaceboDrug
MetforminDrug
Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial.
Insulin GlargineDrug
Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.

Study groups in NCT01682759
Study group	Role	What they receive
Omarigliptin	Experimental	Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. Receives: Drug: Omarigliptin; Drug: Glimepiride Placebo; Drug: Metformin; Drug: Insulin Glargine
Glimepiride	Active comparator	Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks. Receives: Drug: Placebo to Omarigliptin; Drug: Glimepiride; Drug: Metformin; Drug: Insulin Glargine

What is being measured

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

Change From Baseline in Hemoglobin A1C at Week 54
Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
Measured: Baseline and Week 54
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue
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.
Measured: Up to Week 57
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue
Measured: Up to Week 54

Secondary outcomes (5)

Change From Baseline in Fasting Plasma Glucose at Week 54
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).
Measured: Baseline and Week 54
Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54
The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54.
Measured: Week 54
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue
Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).
Measured: Up to Week 54
Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue
Measured: Baseline and Week 54
Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54
The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.
Measured: Week 54

Timeline

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

10 Sep 201226 Jan 2015

First posted11 Sep 2012 (estimated)
Study start10 Sep 2012
Primary completion26 Jan 2015
Study completion26 Jan 2015

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 751 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01682759
Sponsor's protocol ID: 3102-016
Other IDs: MK-3102-016
Status last verified: Aug 2018
First submitted: 7 Sep 2012
Last updated: 7 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Handelsman Y, Lauring B, Gantz I, Iredale C, O'Neill EA, Wei Z, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1861-1868. doi: 10.1080/03007995.2017.1335638. Epub 2017 Jun 28.
PubMed 28548024

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 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
ClinicalTrials.gov ID: NCT01682759
Acronym / sponsor ID: 3102-016
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 751 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 10 Sep 2012 (actual)
Primary completion: 26 Jan 2015 (actual)
Study completion: 26 Jan 2015 (actual)
First posted: 11 Sep 2012 (estimated)
Results: Posted 5 Feb 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Omarigliptin	Experimental	Drug: Omarigliptin, Drug: Glimepiride Placebo, Drug: Metformin, Drug: Insulin GlargineParticipants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
Glimepiride	Active comparator	Drug: Placebo to Omarigliptin, Drug: Glimepiride, Drug: Metformin, Drug: Insulin GlargineParticipants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosed with Type 2 diabetes mellitus
On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control
Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control

Key exclusion criteria (14 listed)

History of type 1 diabetes mellitus or a history of ketoacidosis
Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent
On a weight loss program and is not in the maintenance phase or has
started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
Medical history of active liver disease (other than non-alcoholic

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
Omarigliptin	Drug	Omarigliptin
Placebo to Omarigliptin	Drug	Glimepiride
GlimepirideAlso: AMARYL®, GLIMYGlimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.	Drug	Glimepiride
Glimepiride Placebo	Drug	Omarigliptin
MetforminParticipants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial.	Drug	Glimepiride, Omarigliptin
Insulin GlargineInsulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.	Drug	Glimepiride, Omarigliptin

Primary outcome

Change From Baseline in Hemoglobin A1C at Week 54
Time frame: Baseline and Week 54
Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue
Time frame: Up to Week 57
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.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue
Time frame: Up to Week 54

5 secondary outcomes

Change From Baseline in Fasting Plasma Glucose at Week 54
Time frame: Baseline and Week 54
Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54
Time frame: Week 54
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue
Time frame: Up to Week 54
Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue
Time frame: Baseline and Week 54
Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54
Time frame: Week 54

Results and safety

Results posted to the registry on 5 Feb 2016, 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	376	307
Glimepiride	375	305

Primary outcome: Change From Baseline in Hemoglobin A1C at Week 54

Time frame: Baseline and Week 54. Least squares mean (95% Confidence Interval). Unit: A1C (%)

Measure	Omarigliptin n = 375	Glimepiride n = 375
Value	-0.30 (-0.39 to -0.21)	-0.48 (-0.57 to -0.39)

Omarigliptin vs Glimepiride: Difference in the least squares means: 0.18 (95% CI 0.06 to 0.30)

Population analysed: The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.

Primary outcome: Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue

Time frame: Up to Week 57. Number. Unit: Percentage of participants

Measure	Omarigliptin n = 375	Glimepiride n = 375
Value	54.7	61.6

Omarigliptin vs Glimepiride: Difference in percentages: -6.9 (95% CI -13.9 to 0.1)

Population analysed: All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.

Primary outcome: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue

Time frame: Up to Week 54. Number. Unit: Percentage of participants

Measure	Omarigliptin n = 375	Glimepiride n = 375
Value	3.7	2.7

Omarigliptin vs Glimepiride: Difference in percentages: 1.1 (95% CI -1.6 to 3.8)

Population analysed: The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 57. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omarigliptin	24 of 375 (6.4%)	43 of 375 (11.5%)	Not reported
Glimepiride	18 of 375 (4.8%)	125 of 375 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28548024Handelsman Y, Lauring B, Gantz I, Iredale C, O'Neill EA, Wei Z, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1861-1868. doi: 10.1080/03007995.2017.1335638. Epub 2017 Jun 28.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Type 2 Diabetes Mellitus

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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 3 study testing Omarigliptin, Glimepiride 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 3 inclusion and 14 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 7 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Feb 2016). 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 Hemoglobin A1C at Week 54 (time frame: Baseline and Week 54). The study lists 3 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 NCT01682759, 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 7 Sep 2018.