A study to evaluate the safety and efficacy of the addition of a new drug (MK-3102) in patients with Type 2 Diabetes between the age of 18 and 44 years old, who are not taking any medications

• Register: EUCTR
• Last refreshed on: 11 August 2014
• Main ID: EUCTR2012-004303-12-RO
• Date of registration: 05/08/2014
• Prospective Registration: No
• Primary sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
• Public title: A study to evaluate the safety and efficacy of the addition of a new drug (MK-3102) in patients with Type 2 Diabetes between the age of 18 and 44 years old, who are not taking any medications
• Scientific title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-3102 in =18 and <45 Year-Old Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
• Date of first enrolment: 03/10/2013
• Target sample size: 200
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004303-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Mexico, Peru, Romania, Russian Federation, Serbia, South Africa, Ukraine, United States

Contacts

• Name: Global Clinical Trials Operations
• Affiliation: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Name: Global Clinical Trials Operations
• Affiliation: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
At Visit 1/Screening:

1. Have T2DM and be =18 and <45 years of age on the day of signing the informed consent form.

2. Not be on AHA therapy (drug-naïve or off AHA therapy for at least 12 weeks) and have a Visit 1/Screening A1C =7.0% (53 mmol / mol) and =10.0% (86 mmol / mol). Note: A subject who has received a brief period of insulin treatment (such as few days during a hospitalization) and who no longer requires insulin treatment may participate.

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 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:
1. agrees to remain abstinent from heterosexual activity (if this form of birth control is accepted by local regulatory agencies and review committees as the sole method of birth control). OR
2. agrees to use (or their partner to use) acceptable contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of blinded trial medication. Acceptable combinations of methods include:
- Use of 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 fo 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.

At Visit 3/Randomization/Day 1:

5. Be 100% compliant with MK-3102 placebo treatment during the single-blind run-in period (as determined by site-performed capsule count).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Has a history of type 1 diabetes mellitus or a history of ketoacidosis.
2. Has a C-peptide <0.7 ng/mL (0.23 nmol/L).
3. Has been treated with any AHA therapies within 12 weeks prior to signing informed consent or with MK-3102 at any time prior to signing informed consent.
4. Has a history of hypersensitivity to a DPP-4 inhibitor.
5. 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 12 weeks of signing the informed consent or is not willing to refrain from participating in any other trial.
6. Is on a weight loss program and is not in the maintenance phase; has been on a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to signing the informed consent.
7. Has undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the trial.
8. Is on or likely to require treatment for =14 consecutive 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 (see Section 5.5.2 for a list of prohibited medications).
11. Is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days following the last dose of blinded study medication.
12. Has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease.
13. Has human immunodeficiency virus (HIV) as assessed by medical history.
14. Has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any of the following disorders within the past 3 months:
a. Acute coronary syndrome (e.g., myocardial infarction or unstable angina),
b. Coronary artery intervention (e.g., coronary artery bypass grafting or percutaneous transluminal coronary angioplasty),
c. Stroke or transient ischemic neurological disorder.
15. Has poorly controlled hypertension defined as systolic blood pressure of =160 mm Hg or diastolic blood pressure of =90 mm Hg and blood pressure is unlikely to be below these limits by Visit 2/Week -2 with an adjustment in antihypertensive medication.
16. Has a history of malignancy =5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
17. Has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
18. Is pregnant or breast-feeding, or is expecting to conceive during the trial, including 21 days following the last dose of blinded study medication.
19. Is, at the time of signing informed consent, a 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.
20. 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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus
MedDRA version: 17.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: MK-3102
Product Code: MK-3102
Pharmaceutical Form: Capsule
INN or Proposed INN: Omarigliptin
Current Sponsor code: MK-3102
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Change from baseline in A1C

Main Objective: 1. To assess the effect of treatment with MK-3102 compared with placebo on A1C.

2. To assess the safety and tolerability of MK-3102.

Secondary Objective: 1. To assess the effect of treatment with MK-3102 compared with placebo on 2-hour post-meal glucose (PMG).

2. To assess the effect of treatment with MK-3102 compared with placebo on fasting plasma glucose (FPG).

3. To assess the effect of treatment with MK-3102 on proportion of subjects achieving an A1C goal (<7.0%, <6.5%).

Timepoint(s) of evaluation of this end point: at week 24

Secondary Outcome(s)

Secondary end point(s): 1. Change from baseline in 2-hour PMG
2. Change from baseline in FPG
3. Proportion of subjects achieving an A1C goal <7.0% and < 6.5% after 24 weeks of treatment
4. Time to rescue

Timepoint(s) of evaluation of this end point: at week 24

Secondary ID(s)

MK-3102-028

Source(s) of Monetary Support

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.