Type 2 DiabetesPhase 3NCT01841697
Study to Evaluate the Safety and Efficacy of the Addition of Omarigliptin (MK-3102) Compared With the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)
A Phase 3 study testing Omarigliptin, Sitagliptin and Open-label Metformin in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.
Trial summary
This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Omarigliptin, Sitagliptin and Open-label Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 642 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2013to 17 Nov 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
- Type 2 diabetes mellitus
- Currently on a stable dose of metformin monotherapy (≥1500 mg per day) for at least 12 weeks prior to study participation
- Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain from heterosexual activity or use (or have their partner use) acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug
Who cannot join
- History of type 1 diabetes mellitus or a history of ketoacidosis
- Has been treated with any antihyperglycemic agent (AHA) other than the protocol-required metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to signing informed consent
- History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
- Is currently participating in, or has participated in, a trial in which the participant received an investigational compound or used an investigational device within the prior 12 weeks of signing the informed consent or is not willing to refrain from participating in any other trial
- History of intolerance, hypersensitivity, or any other contraindication to metformin or sitagliptin
- Is on a weight loss program and is not in the maintenance phase or has been on a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
Show all 21Show fewer
- Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study
- Is on or likely to require treatment ≥14 consecutive days or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
- Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks
- Is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days after the last dose of trial medication
- History of active liver disease (other than non-alcoholic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gall bladder disease
- Human immunodeficiency virus (HIV)
- New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, stroke, or transient ischemic attacks in the past 3 months
- Poorly controlled hypertension
- 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
- Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- Positive urine pregnancy test
- Pregnant or breastfeeding, or is expecting to conceive during the study including 21 days following the last dose of blinded study drug
- User of recreational or illicit drugs or has had a recent history of drug abuse
- Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
- Has donated blood products or has had phlebotomy of >300 mL within 8 weeks of study participation, or intends to donate blood products within the projected duration of the trial or has received, or is anticipated to receive, blood products within 12 weeks of study participation or within the projected duration of the trial
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 Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.
- Conditions
- Type 2 Diabetes
- Being tested
- Omarigliptin, Sitagliptin, Placebo to omarigliptin, Placebo to Sitagliptin, Open-label Metformin
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Glimepiride, Metformin, Hypoglycemic Agents, Physiological Effects of Drugs, Pharmacologic Actions
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
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 oral capsule once a week for 24 weeks
SitagliptinDrug
Sitagliptin 100 mg oral tablet once a day for 24 weeks
Placebo to omarigliptinDrug
Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks
Placebo to SitagliptinDrug
Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks
Open-label MetforminDrug
Also called Fortamet®, Glucophage®, Glucophage® XR, Glumetza®
Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day
Open-label GlimepirideDrug
Also called Amaryl®, Glimy
Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy
| Study group | Role | What they receive |
|---|---|---|
| Omarigliptin 25 mg once weekly | Experimental | Participants receive omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy. Receives: Drug: Omarigliptin; Drug: Placebo to Sitagliptin; Drug: Open-label Metformin; Drug: Open-label Glimepiride |
| Sitagliptin 100 mg once daily | Active comparator | Participants receive sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy. Receives: Drug: Sitagliptin; Drug: Placebo to omarigliptin; Drug: Open-label Metformin; Drug: Open-label Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in A1C at Week 24
A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.
Measured: Baseline and Week 24
Percentage of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.
Measured: Up to 27 weeks (including 3-week follow-up)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.
Measured: Up to 24 weeks
Secondary outcomes (3)
Change From Baseline in FPG at Week 24
Participant whole blood samples were collected after an overnight fast at baseline and Week 24 to determine the least squares mean change from baseline in participant FPG.
Measured: Baseline and Week 24
Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment
Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24.
Measured: Week 24
Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment
Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study start13 Jun 2013
- Primary completion17 Nov 2014
- Study completion17 Nov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841697
- Sponsor's protocol ID
- 3102-026
- Other IDs
- 2013-000059-42
- Status last verified
- Aug 2018
- First submitted
- 24 Apr 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
Publications
Goldenberg R, Gantz I, Andryuk PJ, O'Neill EA, Kaufman KD, Lai E, Wang YN, Suryawanshi S, Engel SS. Randomized clinical trial comparing the efficacy and safety of treatment with the once-weekly dipeptidyl peptidase-4 (DPP-4) inhibitor omarigliptin or the once-daily DPP-4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Diabetes Obes Metab. 2017 Mar;19(3):394-400. doi: 10.1111/dom.12832. Epub 2017 Jan 17.
PubMed 28093853
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 Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
- ClinicalTrials.gov ID
- NCT01841697
- Acronym / sponsor ID
- 3102-026
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Glimepiride, Metformin, Hypoglycemic Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2013 (actual)
- Primary completion
- 17 Nov 2014 (actual)
- Study completion
- 17 Nov 2014 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Posted 25 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omarigliptin 25 mg once weekly | Experimental | Drug: Omarigliptin, Drug: Placebo to Sitagliptin, Drug: Open-label Metformin, Drug: Open-label GlimepirideParticipants receive omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy. |
| Sitagliptin 100 mg once daily | Active comparator | Drug: Sitagliptin, Drug: Placebo to omarigliptin, Drug: Open-label Metformin, Drug: Open-label GlimepirideParticipants receive sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- Currently on a stable dose of metformin monotherapy (≥1500 mg per day) for at least 12 weeks prior to study participation
- Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain from heterosexual activity or use (or have their partner use) acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug
Key exclusion criteria (21 listed)
- History of type 1 diabetes mellitus or a history of ketoacidosis
- Has been treated with any antihyperglycemic agent (AHA) other than the protocol-required metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to signing informed consent
- History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
- Is currently participating in, or has participated in, a trial in which the participant received an investigational compound or used an investigational device within the prior 12 weeks of signing the informed consent or is not willing to refrain from participating in any other trial
- History of intolerance, hypersensitivity, or any other contraindication to metformin or sitagliptin
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 oral capsule once a week for 24 weeks | Drug | Omarigliptin 25 mg once weekly |
| SitagliptinSitagliptin 100 mg oral tablet once a day for 24 weeks | Drug | Sitagliptin 100 mg once daily |
| Placebo to omarigliptinPlacebo to omarigliptin 25 mg oral capsule once a week for 24 weeks | Drug | Sitagliptin 100 mg once daily |
| Placebo to SitagliptinPlacebo to sitagliptin 100 mg oral tablet once a day for 24 weeks | Drug | Omarigliptin 25 mg once weekly |
| Open-label MetforminAlso: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day | Drug | Omarigliptin 25 mg once weekly, Sitagliptin 100 mg once daily |
| Open-label GlimepirideAlso: Amaryl®, GlimyGlimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy | Drug | Omarigliptin 25 mg once weekly, Sitagliptin 100 mg once daily |
Primary outcome
Change From Baseline in A1C at Week 24
Time frame: Baseline and Week 24
A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.
Percentage of Participants Who Experienced at Least One Adverse Event
Time frame: Up to 27 weeks (including 3-week follow-up)
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.
3 secondary outcomes
Change From Baseline in FPG at Week 24
Time frame: Baseline and Week 24
Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment
Time frame: Week 24
Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment
Time frame: Week 24
Results and safety
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 28093853Goldenberg R, Gantz I, Andryuk PJ, O'Neill EA, Kaufman KD, Lai E, Wang YN, Suryawanshi S, Engel SS. Randomized clinical trial comparing the efficacy and safety of treatment with the once-weekly dipeptidyl peptidase-4 (DPP-4) inhibitor omarigliptin or the once-daily DPP-4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Diabetes Obes Metab. 2017 Mar;19(3):394-400. doi: 10.1111/dom.12832. Epub 2017 Jan 17.
- 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, Sitagliptin and Open-label Metformin in people with Type 2 Diabetes, 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 21 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. 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 25 Nov 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 A1C at Week 24 (time frame: Baseline and Week 24). 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 NCT01841697, 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; AzTrials last refreshed its copy on 7 Nov 2026.