Type 2 Diabetes MellitusPhase 3NCT01863667

A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)

A Phase 3 study testing Omarigliptin and Glimepiride in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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 and Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: No sites listed yet
Study dates: 8 Jul 2013to 3 Apr 2014
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
Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of metformin
Females of reproductive potential agree to remain abstinent or use or have their partner use 2 acceptable methods of birth control

Who cannot join

History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the investigator as possibly having type 1 diabetes
Has been treated with:
A thiazolidinedione (TZD) within 4 months of study participation, or
A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of study participation, or
Insulin within 12 weeks prior to study participation, or
Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation (4 months if a component of the dual AHA therapy was a TZD)

Show all 14Show fewer

Omarigliptin (MK-3102) at any time prior to study participation
On a weight loss program and is not in the maintenance phase; 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
Human immunodeficiency virus (HIV)
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 Trial to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus For Whom Metformin is Inappropriate Due to Intolerance or Contraindication

This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis 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, Glimepiride, Omarigliptin Placebo, Glimepiride Placebo
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 (MK-3102) 25 mg capsule administered orally once weekly
GlimepirideDrug
Also called AMARYL®, GLIMY
Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal
Omarigliptin PlaceboDrug
Matching placebo to omarigliptin capsule administered orally once weekly
Glimepiride PlaceboDrug
Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal

Study groups in NCT01863667
Study group	Role	What they receive
Omarigliptin	Experimental	Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks. Receives: Drug: Omarigliptin; Drug: Glimepiride Placebo
Glimepiride	Active comparator	Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks. Receives: Drug: Glimepiride; Drug: Omarigliptin Placebo

What is being measured

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

Change From Baseline in Hemoglobin A1C (A1C) at Week 54
A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.
Measured: Baseline and Week 54
Percentage of Participants Who Experienced at Least One Adverse Event
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
Measured: Up to 57 weeks (including 3 weeks following the last dose of study drug)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
Measured: Up to 54 weeks

Secondary outcomes (5)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.
Measured: Baseline and Week 54
Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment
Percentage of participants achieving glycemic goal (A1C <7% or <6.5%) after 54 weeks of treatment.
Measured: 54 weeks
Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment
Percentage of Participants who had an A1C decrease >0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment
Measured: 54 weeks
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia
An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.
Measured: Up to 54 weeks
Change From Baseline in Body Weight at Week 54
Body weight was to be measured (in duplicate) using a calibrated digital scale.
Measured: Baseline and Week 54

Timeline

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

8 Jul 20133 Apr 2014

First posted29 May 2013 (estimated)
Study start8 Jul 2013
Primary completion3 Apr 2014
Study completion3 Apr 2014

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.
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: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01863667
Sponsor's protocol ID: 3102-027
Other IDs: 2013-000301-23
Status last verified: Aug 2018
First submitted: 23 May 2013
Last updated: 10 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

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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All Type 2 Diabetes Mellitus trials

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 III, Multicenter, Double-Blind, Randomized Trial to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus For Whom Metformin is Inappropriate Due to Intolerance or Contraindication
ClinicalTrials.gov ID: NCT01863667
Acronym / sponsor ID: 3102-027
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 65 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 8 Jul 2013 (actual)
Primary completion: 3 Apr 2014 (actual)
Study completion: 3 Apr 2014 (actual)
First posted: 29 May 2013 (estimated)
Results: Posted 21 Jan 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 PlaceboParticipants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
Glimepiride	Active comparator	Drug: Glimepiride, Drug: Omarigliptin PlaceboParticipants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 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
Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of metformin
Females of reproductive potential agree to remain abstinent or use or have their partner use 2 acceptable methods of birth control

Key exclusion criteria (14 listed)

History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the investigator as possibly having type 1 diabetes
Has been treated with:
On a weight loss program and is not in the maintenance phase; 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
Human immunodeficiency virus (HIV)

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 (MK-3102) 25 mg capsule administered orally once weekly	Drug	Omarigliptin
GlimepirideAlso: AMARYL®, GLIMYGlimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal	Drug	Glimepiride
Omarigliptin PlaceboMatching placebo to omarigliptin capsule administered orally once weekly	Drug	Glimepiride
Glimepiride PlaceboMatching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal	Drug	Omarigliptin

Primary outcome

Change From Baseline in Hemoglobin A1C (A1C) at Week 54
Time frame: Baseline and Week 54
A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.
Percentage of Participants Who Experienced at Least One Adverse Event
Time frame: Up to 57 weeks (including 3 weeks following the last dose of study drug)
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 54 weeks
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.

5 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
Time frame: Baseline and Week 54
Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment
Time frame: 54 weeks
Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment
Time frame: 54 weeks
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia
Time frame: Up to 54 weeks
Change From Baseline in Body Weight at Week 54
Time frame: Baseline and Week 54

Results and safety

Results posted to the registry on 21 Jan 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	33	0
Glimepiride	32	0

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

Time frame: Baseline and Week 54

Population analysed: Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.

Primary outcome: Percentage of Participants Who Experienced at Least One Adverse Event

Time frame: Up to 57 weeks (including 3 weeks following the last dose of study drug). Number. Unit: Percentage of participants

Measure	Omarigliptin n = 33	Glimepiride n = 32
Value	9.1	15.6

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

Primary outcome: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

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

Measure	Omarigliptin n = 33	Glimepiride n = 32
Value	3	0

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 57 weeks (including 3 weeks following last dose of study drug). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omarigliptin	1 of 33 (3%)	0 of 33 (0%)	Not reported
Glimepiride	0 of 32 (0%)	0 of 32 (0%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated based on business decisions only, and not due to any unexpected safety or efficacy concerns.

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.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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 and Glimepiride 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: stopped early, 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. 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 21 Jan 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 (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 NCT01863667.

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.