SUBJECT INCLUSION CRITERIA
All laboratory measurements are to be performed after an
overnight fast hours in
duration. Subjects with laboratory screening values/findings
not meeting protocol
inclusion criteria may, at the discretion of the
investigator, have one repeat determination
performed by the central laboratory. If the repeat value
satisfies the criterion they may
continue in the screening process. Only laboratory tests not
meeting inclusion criteria are
to be repeated (not the entire panel).
Subjects must meet all of the following criteria to
participate in the trial.
At Visit 1/Screening
1. Subject has T2DM and must be of age on the day of signing
the informed
consent form. For India: subject has T2DM and is 65 years of
age.
2. Subject is on a stable dose of metformin ( 1500 mg/day)
for at least 12 weeks with
inadequate glycemic control, i.e., A1C (48 mmol/mol) and .0%
(75
mmol/mol).
3. Subject meets 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:
(1) 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
(2) 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 ethics
review committees
as the sole method of birth control), or
(2) 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 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.
3102, Protocol 016-02 Issue Date: 28-Mar-2013 19
Product: MK-3102 9
Protocol/Amendment No.: 016-02
3102_016-02_ProtCore APPROVED 28-Mar-2013
Worldwide Restricted Confidential – Limited Access
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. Subject understands 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. Subject has 100% compliance with MK-3102 placebo
treatment during the single
blind run-in period (as determined by site-performed capsule
count).
AND
Subject has 85% compliance with glimepiride placebo
treatment during the singleblind
run-in period (as determined by site-performed capsule
count).
All laboratory measurements are to be performed after an
overnight fast hours in
duration. Subjects with laboratory screening values/findings
meeting protocol exclusion
criteria may, at the discretion of the investigator, have
one repeat determination
performed by the central laboratory. If the repeat value
does not meet the criterion, the
subject may continue in the screening process. Only laboratory
tests meeting exclusion
criteria are to be repeated (not the entire panel).
Subjects must be excluded if they meet any of the following
criteria.
3102, Protocol 016-02 Issue Date: 28-Mar-2013 20
Product: MK-3102 10
Protocol/Amendment No.: 016-02
3102_016-02_ProtCore APPROVED 28-Mar-2013
Worldwide Restricted Confidential – Limited Access