Type 2 Diabetes MellitusPhase 3NCT01697592

Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)

A Phase 3 study testing Omarigliptin 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.

Trial summary

This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Omarigliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 585 participants
Where: No sites listed yet
Study dates: 24 Oct 2012to 8 May 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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has type 2 diabetes mellitus
Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy

Who cannot join

History of type 1 diabetes mellitus or a history of ketoacidosis
History of any of the following medications: Thiazolidinediones (TZD) (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime

About this study

Official title: A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy

Read the detailed description

The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). During Phase A, participants will received either omarigliptin 25 mg or a matching placebo. During Phase, B all participants will receive omarigliptin 25 mg. All participants will remain on a stable dose and administration of a single oral antihyperglycemic basal medication.

Conditions: Type 2 Diabetes Mellitus
Being tested: Omarigliptin, Matching placebo to omarigliptin
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. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
Matching placebo to omarigliptinDrug
Matching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).

Study groups in NCT01697592
Study group	Role	What they receive
Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)	Experimental	Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study. Receives: Drug: Omarigliptin
Omarigliptin 25 mg/Glinides (Phase A+B)	Experimental	Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study. Receives: Drug: Omarigliptin
Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)	Experimental	Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study. Receives: Drug: Omarigliptin
Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)	Experimental	Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study. Receives: Drug: Omarigliptin
Omarigliptin 25 mg/α-GIs (Phase A+B)	Experimental	Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study. Receives: Drug: Omarigliptin
Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)	Placebo comparator	Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study. Receives: Drug: Omarigliptin; Drug: Matching placebo to omarigliptin
Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)	Placebo comparator	Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study. Receives: Drug: Omarigliptin; Drug: Matching placebo to omarigliptin
Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)	Placebo comparator	Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study. Receives: Drug: Omarigliptin; Drug: Matching placebo to omarigliptin
Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)	Placebo comparator	Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study. Receives: Drug: Omarigliptin; Drug: Matching placebo to omarigliptin
Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)	Placebo comparator	Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study. Receives: Drug: Omarigliptin; Drug: Matching placebo to omarigliptin

What is being measured

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

Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A
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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
Measured: Up to 24 weeks
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study
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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
Measured: Up to 52 weeks
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
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, that occurs during the course of the study.
Measured: Up to 24 weeks
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
Measured: Up to 52 weeks

Secondary outcomes (1)

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.
Measured: Baseline and Week 24

Timeline

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

24 Oct 20128 May 2014

First posted2 Oct 2012 (estimated)
Study start24 Oct 2012
Primary completion8 May 2014
Study completion8 May 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 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 585 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01697592
Sponsor's protocol ID: 3102-015
Other IDs: 132242
Status last verified: Aug 2018
First submitted: 28 Sep 2012
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

Gantz I, Okamoto T, Ito Y, Sato A, Okuyama K, O'Neill EA, Engel SS, Lai E; Omarigliptin Study 015 Group. A Randomized, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Adding Omarigliptin to Antihyperglycemic Therapies in Japanese Patients with Type 2 Diabetes and Inadequate Glycemic Control. Diabetes Ther. 2017 Aug;8(4):793-810. doi: 10.1007/s13300-017-0270-7. Epub 2017 Jun 6.
PubMed 28589493

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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Type 2 Diabetes
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy
ClinicalTrials.gov ID: NCT01697592
Acronym / sponsor ID: 3102-015
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 585 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 24 Oct 2012 (actual)
Primary completion: 8 May 2014 (actual)
Study completion: 8 May 2014 (actual)
First posted: 2 Oct 2012 (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: 10

Arm	Type	Receives
Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)	Experimental	Drug: OmarigliptinOmarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study.
Omarigliptin 25 mg/Glinides (Phase A+B)	Experimental	Drug: OmarigliptinOmarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study.
Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)	Experimental	Drug: OmarigliptinOmarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study.
Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)	Experimental	Drug: OmarigliptinOmarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study.
Omarigliptin 25 mg/α-GIs (Phase A+B)	Experimental	Drug: OmarigliptinOmarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study.
Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)	Placebo comparator	Drug: Omarigliptin, Drug: Matching placebo to omarigliptinPlacebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study.
Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)	Placebo comparator	Drug: Omarigliptin, Drug: Matching placebo to omarigliptinPlacebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study.
Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)	Placebo comparator	Drug: Omarigliptin, Drug: Matching placebo to omarigliptinPlacebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study.
Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)	Placebo comparator	Drug: Omarigliptin, Drug: Matching placebo to omarigliptinPlacebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study.
Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)	Placebo comparator	Drug: Omarigliptin, Drug: Matching placebo to omarigliptinPlacebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Has type 2 diabetes mellitus
Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy

Key exclusion criteria (2 listed)

History of type 1 diabetes mellitus or a history of ketoacidosis
History of any of the following medications: Thiazolidinediones (TZD) (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime

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. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).	Drug	Omarigliptin 25 mg/Glinides (Phase A+B), Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B), Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B), Omarigliptin 25 mg/biguanides (BGs) (Phase A+B), Omarigliptin 25 mg/α-GIs (Phase A+B), Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B), Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B), Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B), Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B), Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)
Matching placebo to omarigliptinMatching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).	Drug	Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B), Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B), Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B), Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B), Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)

Primary outcome

Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A
Time frame: Up to 24 weeks
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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study
Time frame: Up to 52 weeks
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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
Time frame: Up to 24 weeks
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, that occurs during the course of the study.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
Time frame: Up to 52 weeks
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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.

1 secondary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time frame: Baseline and Week 24

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 25 mg/Sulfonylureas (SU) (Phase A+B)	126	123
Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)	65	62
Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)	66	65
Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)	65	63
Omarigliptin 25 mg/α-GI (Phase A+B)	67	67
Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)	63	62
Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)	34	32
Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)	33	33
Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)	34	34
Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)	32	30

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

Time frame: Up to 24 weeks. Number. Unit: Percentage of participants

Measure	Omarigliptin 25 mg/SU (Phase A) n = 126	Omarigliptin 25 mg/Gln (Phase A) n = 65	Omarigliptin 25 mg/BG (Phase A) n = 66	Omarigliptin 25 mg/TZD (Phase A) n = 65	Omarigliptin 25 mg/α-GI (Phase A) n = 67	Placebo/SU (Phase A) n = 63	Placebo/Gln. (Phase A) n = 34	Placebo/BG (Phase A) n = 33	Placebo/TZD (Phase A) n = 34	Placebo/α-GI (Phase A) n = 32
Value	59.5	53.8	54.5	60.0	50.7	60.3	52.9	63.6	52.9	53.1

Population analysed: All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.

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

Time frame: Up to 52 weeks. Number. Unit: Percentage of participants

Measure	Omarigliptin 25 mg/SU (Phase A+B) n = 126	Omarigliptin 25 mg/Gln (Phase A+B) n = 65	Omarigliptin 25 mg/BG (Phase A+B) n = 66	Omarigliptin 25 mg/TZD (Phase A+B) n = 65	Omarigliptin 25 mg/α-GI (Phase A+B) n = 67	Omarigliptin 25mg/SU (Phase B) n = 62	Omarigliptin 25mg/Gln (Phase B) n = 32	Omarigliptin 25mg/BG (Phase B) n = 33	Omarigliptin 25mg/TZD (Phase B) n = 34	Omarigliptin 25mg/α-GI (Phase B) n = 30
Value	76.2	75.4	80.3	84.6	68.7	56.5	59.4	66.7	58.8	53.3

Population analysed: The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.

Primary outcome: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A

Time frame: Up to 24 weeks. Number. Unit: Percentage of Participants

Measure	Omarigliptin 25 mg/SU (Phase A) n = 126	Omarigliptin 25 mg/Gln (Phase A) n = 65	Omarigliptin 25 mg/BG (Phase A) n = 66	Omarigliptin 25 mg/TZD (Phase A) n = 65	Omarigliptin 25 mg/α-GI (Phase A) n = 67	Placebo/SU (Phase A) n = 63	Placebo/Gln. (Phase A) n = 34	Placebo/BG (Phase A) n = 33	Placebo/TZD (Phase A) n = 34	Placebo/α-GI (Phase A) n = 32
Value	0	3.1	0	3.1	0	0	2.9	0	0	3.1

Population analysed: The ASaT population was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.

Primary outcome: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study

Time frame: Up to 52 weeks. Number. Unit: Percentage of participants

Measure	Omarigliptin 25 mg/SU (Phase A+B) n = 126	Omarigliptin 25 mg/Gln (Phase A) n = 65	Omarigliptin 25 mg/BG (Phase A+B) n = 66	Omarigliptin 25 mg/TZD (Phase A+B) n = 65	Omarigliptin 25 mg/α-GI (Phase A+B) n = 67	Omarigliptin 25mg/SU (Phase B) n = 62	Omarigliptin 25mg/Gln (Phase B) n = 32	Omarigliptin 25mg/BG (Phase B) n = 33	Omarigliptin 25mg/TZD (Phase B) n = 34	Omarigliptin 25mg/α-GI (Phase B) n = 30
Value	0.8	4.6	1.5	6.2	0	1.6	0	0	2.9	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52]). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omarigliptin 25 mg/SU (Phase A)	3 of 126 (2.4%)	33 of 126 (26.2%)	Not reported
Omarigliptin 25 mg/Gln (Phase A)	1 of 65 (1.5%)	19 of 65 (29.2%)	Not reported
Omarigliptin 25 mg/BG (Phase A)	1 of 66 (1.5%)	22 of 66 (33.3%)	Not reported
Omarigliptin 25 mg/TZD (Phase A)	4 of 65 (6.2%)	18 of 65 (27.7%)	Not reported
Omarigliptin 25 mg/α-GI (Phase A)	0 of 67 (0%)	19 of 67 (28.4%)	Not reported
Placebo/ABM (Phase A)	4 of 196 (2%)	62 of 196 (31.6%)	Not reported
Omarigliptin 25 mg/SU (Phase A+B)	6 of 126 (4.8%)	58 of 126 (46%)	Not reported
Omarigliptin 25 mg/Gln (Phase A+B)	3 of 65 (4.6%)	29 of 65 (44.6%)	Not reported
Omarigliptin 25 mg/BG (Phase A+B)	2 of 66 (3%)	33 of 66 (50%)	Not reported
Omarigliptin 25 mg/TZD (Phase A+B)	4 of 65 (6.2%)	30 of 65 (46.2%)	Not reported
Omarigliptin 25 mg/α-GI (Phase A+B)	1 of 67 (1.5%)	26 of 67 (38.8%)	Not reported
Omarigliptin 25mg/ABM (Phase B)	7 of 191 (3.7%)	60 of 191 (31.4%)	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 28589493Gantz I, Okamoto T, Ito Y, Sato A, Okuyama K, O'Neill EA, Engel SS, Lai E; Omarigliptin Study 015 Group. A Randomized, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Adding Omarigliptin to Antihyperglycemic Therapies in Japanese Patients with Type 2 Diabetes and Inadequate Glycemic Control. Diabetes Ther. 2017 Aug;8(4):793-810. doi: 10.1007/s13300-017-0270-7. Epub 2017 Jun 6.
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 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 2 inclusion and 2 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 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 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?

Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A (time frame: Up to 24 weeks). The study lists 4 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 NCT01697592, 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.