Clinical Trials Register

Summary
EudraCT Number:	2012-002612-10
Sponsor's Protocol Code Number:	MK-3102-022
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-02-08
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2012-002612-10

A.3

Full title of the trial

A Phase III, Multicenter, Randomized, Double-Blind, Placebo Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy with Glimepiride and Metformin

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to evaluate the safety and efficacy of the addition of a new drug (MK-3102) in patients with Type 2 Diabetes who are also receiving Glimepiride and Metformin

A.4.1

Sponsor's protocol code number

MK-3102-022

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.5.2	Functional name of contact point	Global Clinical Trials Operations
B.5.3	Address:
B.5.3.1	Street Address	One Merck Drive
B.5.3.2	Town/ city	Whitehouse Station, NJ
B.5.3.3	Post code	08889-0100
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 732 594 2622
B.5.5	Fax number	+1 732-594-3560
B.5.6	E-mail	ira_gantz@merck.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MK-3102
D.3.2	Product code	MK-3102
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Omarigliptin
D.3.9.2	Current sponsor code	MK-3102
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Type 2 Diabetes Mellitus

E.1.1.1

Medical condition in easily understood language

Type 2 Diabetes Mellitus

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10067585
E.1.2	Term	Type 2 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

(1) After 24 weeks, to assess the effect of the addition of treatment with MK- 3102 compared with the addition of placebo on A1C.

(2) To assess the safety and tolerability of MK 3102.

E.2.2

Secondary objectives of the trial

(1) After 24 weeks, to assess the effect of the addition of treatment with MK- 3102 compared with the addition of placebo on fasting plasma glucose (FPG).

(2) After 24 weeks, to assess the proportion of subjects attaining A1C
goals of <7% (53 mmol/mol) and <6.5% (48 mmol/mol) with the
addition of treatment with MK-3102 compared with the addition of
placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have T2DM and be ≥18 years of age (For India: ≥18 and ≤65 years of age) on the day of signing the informed consent form.
2. Meet one of the following criteria:
a. Subject is currently taking stable doses of metformin (≥1500 mg/day) and glimepiride (≥4 mg/day) for ≥12 weeks prior to Visit 1 and has an
A1C ≥7.5% (58 mmol/mol) and ≤10.5% (91 mmol/mol). OR
b. Subject is in one of the following categories and based upon review of
the subject's current diet, medical regimen, and Visit 1 A1C, subject is
considered by the investigator to be likely to meet the Visit 3/Week -2
inclusion criterion of A1C ≥7.5% (58 mmol/mol) and ≤10.5% (91
mmol/mol). AFTER the up to 4-week sulfonylurea switch/up-titration
period and 6-week dose stabilization period prior to Visit 3/Week-2.
- Subject is currently taking stable doses of metformin (≥1500 mg/day)
for ≥12 weeks and glimepiride (<4 mg/day) for ≥6 weeks prior to Visit 1
and has an A1C ≥7.5% (58 mmol/mol) and ≤10.5% (91 mmol/mol).
- Subject is currently taking stable doses of metformin (≥1500 mg/day)
for ≥12 weeks and a sulfonylurea (other than glimepiride) for ≥6 weeks
prior to Visit 1 and has an A1C ≥7.5% (58 mmol/mol) and ≤10.5% (91
mmol/mol).
3. Meet one of the following criteria:
a. Subject is a male;
b. Subject is a female not of reproductive potential defined as one who
has either:
- reached natural menopause (defined as ≥12 months of spontaneous
amenorrhea in women >45 years of age, or ≥6 months of spontaneous
amenorrhea with serum follicular stimulating hormone [FSH] levels in
the postmenopausal range as determined by the laboratory), or
- had a hysterectomy and/or bilateral oophorectomy, or had bilateral
tubal ligation or occlusion at least 6 weeks prior to screening.
c. Subject is a female of reproductive potential and:
- agrees to remain abstinent from heterosexual activity (if this form of
birth control is accepted by local regulatory agencies and ethics review
committees as the sole method of birth control),
OR
- agrees to use (or have their partner use) acceptable contraception to
prevent pregnancy within the projected duration of the trial and for 21
days after the last dose of blinded study medication. Two methods of
contraception will be used to
avoid pregnancy. Acceptable combinations of methods include:
- Use one of the following double-barrier methods: diaphragm with
spermicide and a condom; cervical cap and a condom; or contraceptive
sponge and a condom.
- Use of hormonal contraception (any registered and marketed
contraceptive agent that contains an estrogen and/or a progestational
agent [including oral, subcutaneous, intrauterine and intramuscular
agents, and cutaneous patch]) with one of the following: diaphragm with
spermicide; cervical cap; contraceptive sponge; condom; vasectomy; or
intrauterine device (IUD).
- Use of an IUD with one of the following: condom; diaphragm with
spermicide; contraceptive sponge; vasectomy; or hormonal
contraception (see above).
- Vasectomy with one of the following: diaphragm with spermicide;
cervical cap; contraceptive sponge; condom; IUD; or hormonal
contraception (see above).
4. Understand the trial procedures, alternative treatments available, and
risks involved with the trial, and voluntarily agrees to participate by
giving written informed consent. The subject may also provide consent
for Future Biomedical Research. However, the subject may participate in
the main trial without participating in Future Biomedical Research.
5. Have an A1C ≥7.5% (58 mmol/mol) and ≤10.5% (91 mmol/mol).
6. Must be 100% compliant with MK-3102 placebo treatment during the
single-blind run-in period (as determined by site-performed capsule
count).

E.4

Principal exclusion criteria

1. Has a history of T1DM or a history of ketoacidosis. OR Subject is assessed by the investigator as possibly having T1DM confirmed with a Cpeptide <0.7 ng/mL (0.23 nmol/L).
2. Has been treated with any AHA therapies other than the protocolrequired sulfonylurea and metformin within 12 weeks prior to signing ICF or with MK-3102 at any time prior to signing ICF
3. Has a history of hypersensitivity to a DPP-4 inhibitor.
4. Is currently participating in, or has participated, in a trial in which the subject received an investigational compound or used an investigational device within the prior 12weeks of signing the ICF or is not willing to refrain from participating in any other trial.
5. Has a history of intolerance or hypersensitivity to glimepiride or metformin or any contraindication to glimepiride or metformin based upon the label in the country of the investigational site.
6. Is on a weight loss program and is not in the maintenance phase has been on a weight loss medication in the past 6months or has undergone bariatric surgery within 12months prior to signing the informed consent.
7. Has undergone a surgical procedure within 4weeks prior to signing informed consent or has planned major surgery during the trial.
8. Is on or likely to require treatment for ≥14consecutive days or repeated courses of pharmacologic doses of corticosteroids.
9. Is currently being treated for hyperthyroidism or subject is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks.
10. Is currently on or likely to require treatment with a prohibited medication
11. Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepB or C, primary biliary cirrhosis, or symptomatic gallbladder disease.
12. Has HIV as assessed by medical history.
13. Has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3months
14. Has poorly controlled hypertension defined as systolic blood pressure of ≥160 mm Hg or diastolic blood pressure of ≥90mm Hg and blood pressure is unlikely to be below these limits by Visit 3/Week -2 with an adjustment in antihypertensive medication.
15. Has a history of malignancy ≤5years prior to signing informed consent, except for adequately treated basal cell or squamous cell skincancer, or in situ cervical cancer.
16. Has a clinically important hematological disorder.
17. Has exclusionary laboratory values as listed in protocol
18. Has a positive urine pregnancy test.
19. Is pregnant, breast-feeding, expecting to conceive, including 21 days following the last dose of blinded drug OR Is expecting to undergo hormonal therapy in preparation to donate eggs including 21days following the last dose of drug
20. Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug abuse. Subject routinely consumes >2alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking.
21. Has a history or current evidence of any condition, therapy, laboratory test abnormality or other circumstance that a. makes participation not in the subject's best interest, b. might interfere with
the subject's participation for the full duration of the trial, c. might confound the results of the trial.
22. Has donated blood products or has had phlebotomy of >300 mL within 8weeks of signing ICF, or intends to donate blood products within the projected duration of the trial OR subject has received, or is anticipated to receive, blood products within12 weeks of signing ICF or within the projected duration of the trial.
23. Is unlikely to adhere to the trial procedures, keep appointments, or is planning to relocate during the trial.
24. Has a clinically significant ECG abnormality which in the opinion of the investigator exposes the subject to risk by enrolling in the trial.
25. Has poorly controlled hypertension defined as systolic blood pressure of ≥160mmHg or diastolic blood pressure of ≥90mmHg.
26. Has a positive urine pregnancy test.
27. Is on lipid-lowering medication or thyroid replacement therapy, and has not been on a stable regimen for the 4 weeks (lipid-lowering medication), or 6 weeks (thyroid replacement therapy) prior to Visit 4/Day 1. In this case the current visit can be changed to an Unscheduled Visit, and the subject should be rescheduled for a Visit 4/Day 1.
28. Has a positive urine pregnancy test.
29. Has a site-fasting-fingerstick glucose (FFSG) <130 mg/dL (<7.2 mmol/L) or >260 mg/dL (>14.4 mmol/L).
30. Has developed a new medical condition, suffered a change in status of an established medical condition, developed a laboratory or ECG abnormality, or required a new treatment or medication during the prerandomization period which meets any previously described trial exclusion criteria or which, in the opinion of the investigator, exposes the subject to risk by enrolling in the trial.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in A1C at Week 24

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

E.5.2

Secondary end point(s)

- Change from baseline in FPG at Week 24
- Proportion of subjects attaining A1C glycemic goals of <7% (53
mmol/mol) and <6.5% (48 mmol/mol) after 24 weeks of treatment

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 24

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Brazil

India

Korea, Republic of

Mexico

Poland

Romania

Russian Federation

South Africa

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

285

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

300

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will return to routine clinical care

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-04-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-23

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