Type 2 Diabetes MellitusPhase 3NCT01698775

A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)

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

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Omarigliptin, Glipizide and Insulin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 213 participants
Where: No sites listed yet
Study dates: 2 Oct 2012to 19 Jan 2016
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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus and be at least 30 years of age
Moderate or severe chronic renal insufficiency or end stage renal disease on dialysis
Meet one of the following criteria:
is currently not on an antihyperglycemic agent (AHA) and has A1C >=7% and <=10% at screening
is currently on a single oral AHA or low-dose dual oral combination AHA and has A1C >=6.5% and <=9% at screening
is currently on a stable insulin regimen (>= 15 U/day) for >= 10 weeks, with no oral AHA, and has A1C >=7.5% and <=10% and FPG >130 mg/dL at screening
(1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 28 days after the last dose of study drug

Who cannot join

History of type 1 diabetes mellitus or a history of ketoacidosis
Treated with any incretin mimetic or thiazolidinedione (TZD) within 12 weeks prior to screening or with omarigliptin at any time prior to study participation
History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
History of intolerance or hypersensitivity to glipizide or insulin glargine or any contraindication to glipizide or insulin glargine
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
Undergone a surgical procedure within 4 weeks prior to screening or has planned major surgery during the trial

Show all 20Show fewer

On or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal or topical corticosteroids are permitted)
Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks
If on dialysis, does not regularly adhere to dialysis schedule
Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class IV
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
Poorly controlled hypertension
Severe active peripheral vascular disease
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)
Positive pregnancy test
Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the trial, including 28 days following the last dose of study drug
User of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking

About this study

Official title: A Phase III, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects With Type 2 Diabetes Mellitus With Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control.

The purpose of this study is to evaluate the efficacy and safety of omarigliptin in participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency or end stage renal disease on dialysis with inadequate glycemic control. The primary hypothesis of the study is that omarigliptin compared to placebo produces greater reduction in glycosylated hemoglobin (A1C) after 24 weeks.

Conditions: Type 2 Diabetes Mellitus
Being tested: Omarigliptin, Placebo to omarigliptin, Glipizide, Placebo to glipizide, Insulin
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
Also called MK-3102
Participants with moderate renal insufficiency will receive one omarigliptin 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one omarigliptin 12.5 mg capsule orally once a week
Placebo to omarigliptinDrug
Matching placebo to omarigliptin capsule administered orally once a week
GlipizideDrug
Also called Glucotrol, Glucotrol XL
Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study Week 1 through Week 24) will receive glipizide capsule(s) 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Placebo to glipizideDrug
Matching placebo to glipizide daily
InsulinBiological
Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.

Study groups in NCT01698775
Study group	Role	What they receive
Omarigliptin (Phase A) → Omarigliptin (Phase B)	Experimental	Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54). Receives: Drug: Omarigliptin; Drug: Glipizide; Drug: Placebo to glipizide; Biological: Insulin
Placebo to omarigliptin (Phase A) → Glipizide (Phase B)	Active comparator	Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54). Receives: Drug: Placebo to omarigliptin; Drug: Glipizide; Drug: Placebo to glipizide; Biological: Insulin

What is being measured

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

Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24
A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
Measured: Baseline and Week 24
Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Measured: Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Measured: Up to 24 weeks
Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Measured: Up to 58 weeks (including 28 days following the last dose of study therapy)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Measured: Up to 54 weeks

Secondary outcomes (5)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
Measured: Baseline and Week 24
Change From Baseline in A1C at Week 54
A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
Measured: Baseline and Week 54
Change From Baseline in FPG at Week 54
Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
Measured: Baseline and Week 54
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.
Measured: Baseline and Week 24
Change From Baseline in eGFR at Week 54
Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis.
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.

2 Oct 201219 Jan 2016

First posted3 Oct 2012 (estimated)
Study start2 Oct 2012
Primary completion19 Jan 2016
Study completion19 Jan 2016

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: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01698775
Sponsor's protocol ID: 3102-019
Other IDs: 2012-002332-85
Status last verified: Sep 2017
First submitted: 1 Oct 2012
Last updated: 9 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chacra A, Gantz I, Mendizabal G, Durlach L, O'Neill EA, Zimmer Z, Suryawanshi S, Engel SS, Lai E. A randomised, double-blind, trial of the safety and efficacy of omarigliptin (a once-weekly DPP-4 inhibitor) in subjects with type 2 diabetes and renal impairment. Int J Clin Pract. 2017 Jun;71(6):e12955. doi: 10.1111/ijcp.12955. Epub 2017 Apr 27.
PubMed 28449320

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
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 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects With Type 2 Diabetes Mellitus With Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control.
ClinicalTrials.gov ID: NCT01698775
Acronym / sponsor ID: 3102-019
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 2 Oct 2012 (actual)
Primary completion: 19 Jan 2016 (actual)
Study completion: 19 Jan 2016 (actual)
First posted: 3 Oct 2012 (estimated)
Results: Posted 23 Feb 2017

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Omarigliptin (Phase A) → Omarigliptin (Phase B)	Experimental	Drug: Omarigliptin, Drug: Glipizide, Drug: Placebo to glipizide, Biological: InsulinPhase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
Placebo to omarigliptin (Phase A) → Glipizide (Phase B)	Active comparator	Drug: Placebo to omarigliptin, Drug: Glipizide, Drug: Placebo to glipizide, Biological: InsulinPhase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Type 2 diabetes mellitus and be at least 30 years of age
Moderate or severe chronic renal insufficiency or end stage renal disease on dialysis
Meet one of the following criteria:
(1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 28 days after the last dose of study drug

Key exclusion criteria (20 listed)

History of type 1 diabetes mellitus or a history of ketoacidosis
Treated with any incretin mimetic or thiazolidinedione (TZD) within 12 weeks prior to screening or with omarigliptin at any time prior to study participation
History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
History of intolerance or hypersensitivity to glipizide or insulin glargine or any contraindication to glipizide or insulin glargine
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

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
OmarigliptinAlso: MK-3102Participants with moderate renal insufficiency will receive one omarigliptin 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one omarigliptin 12.5 mg capsule orally once a week	Drug	Omarigliptin (Phase A) → Omarigliptin (Phase B)
Placebo to omarigliptinMatching placebo to omarigliptin capsule administered orally once a week	Drug	Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
GlipizideAlso: Glucotrol, Glucotrol XLPhase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study Week 1 through Week 24) will receive glipizide capsule(s) 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).	Drug	Omarigliptin (Phase A) → Omarigliptin (Phase B), Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
Placebo to glipizideMatching placebo to glipizide daily	Drug	Omarigliptin (Phase A) → Omarigliptin (Phase B), Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
InsulinParticipants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.	Biological	Omarigliptin (Phase A) → Omarigliptin (Phase B), Placebo to omarigliptin (Phase A) → Glipizide (Phase B)

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24
Time frame: Baseline and Week 24
A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)
Time frame: Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)
Time frame: Up to 24 weeks
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)
Time frame: Up to 58 weeks (including 28 days following the last dose of study therapy)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)
Time frame: Up to 54 weeks
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.

5 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in A1C at Week 54
Time frame: Baseline and Week 54
Change From Baseline in FPG at Week 54
Time frame: Baseline and Week 54
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in eGFR at Week 54
Time frame: Baseline and Week 54

Results and safety

Results posted to the registry on 23 Feb 2017, 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 (Phase A) → Omarigliptin (Phase B)	107	98
Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)	106	97

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24

Time frame: Baseline and Week 24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Omarigliptin (Phase A) n = 106	Placebo to Omarigliptin (Phase A) n = 106
Value	-0.77 (-1.00 to -0.54)	-0.44 (-0.67 to -0.21)

Omarigliptin (Phase A) vs Placebo to Omarigliptin (Phase A): Difference in least squares means: -0.33 (95% CI -0.63 to -0.02), p = 0.035, ANCOVA

Population analysed: Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.

Primary outcome: Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)

Time frame: Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug). Number. Unit: Percentage of participants

Measure	Omarigliptin (Phase A) n = 106	Placebo to Omarigliptin (Phase A) n = 106
Value	66.0	69.8

Omarigliptin (Phase A) vs Placebo to Omarigliptin (Phase A): Difference in percentages: -3.8 (95% CI -16.3 to 8.8)

Population analysed: All-Participants-as-Treated (APaT) population consists of all randomized participants who took at least 1 dose of trial treatment.

Primary outcome: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)

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

Measure	Omarigliptin (Phase A) n = 106	Placebo to Omarigliptin (Phase A) n = 106
Value	2.8	0.9

Omarigliptin (Phase A) vs Placebo to Omarigliptin (Phase A): Difference in percentages: 1.9 (95% CI -2.6 to 7.2)

Population analysed: APaT population consists of all randomized participants who took at least 1 dose of trial treatment.

Primary outcome: Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)

Time frame: Up to 58 weeks (including 28 days following the last dose of study therapy). Number. Unit: Percentage of participants

Measure	Omarigliptin (Phase A) → Omarigliptin (Phase B) n = 106	Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) n = 106
Value	77.4	78.3

Omarigliptin (Phase A) → Omarigliptin (Phase B) vs Placebo to Omarigliptin (Phase A) → Glipizide (Phase B): Difference in percentage: -0.9 (95% CI -12.2 to 10.3)

Population analysed: APaT population consists of all randomized participants who took at least 1 dose of trial treatment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omarigliptin (Phase A)	10 of 106 (9.4%)	24 of 106 (22.6%)	Not reported
Placebo to Omarigliptin (Phase A)	13 of 106 (12.3%)	25 of 106 (23.6%)	Not reported
Omarigliptin (Phase A) → Omarigliptin (Phase B)	22 of 106 (20.8%)	44 of 106 (41.5%)	Not reported
Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)	22 of 106 (20.8%)	52 of 106 (49.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28449320Chacra A, Gantz I, Mendizabal G, Durlach L, O'Neill EA, Zimmer Z, Suryawanshi S, Engel SS, Lai E. A randomised, double-blind, trial of the safety and efficacy of omarigliptin (a once-weekly DPP-4 inhibitor) in subjects with type 2 diabetes and renal impairment. Int J Clin Pract. 2017 Jun;71(6):e12955. doi: 10.1111/ijcp.12955. Epub 2017 Apr 27.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
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)

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, Glipizide and Insulin 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 7 inclusion and 20 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 9 Aug 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 23 Feb 2017). 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 Glycosylated Hemoglobin (A1C) at Week 24 (time frame: Baseline and Week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01698775, 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 9 Aug 2018.