A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-ArmClinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea inPatients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin Therapy - ND

• Conditions: Type 2 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-005616-40-IT
• Lead Sponsor: MERCK & CO., INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Visit 1/Screening
a. Patient has type 2 diabetes mellitus (T2DM).b. Patient is ≥18 and ≤70 years of age on day of signing informed consent.
c. Patient has a body mass index (BMI) >20 kg/m2 and <43 kg/m2.
d. Patient is in one of the following categories:
1. Patient is currently on single oral AHA and has an A1C &#8805;7.5% and &#8804;11.0%.
OR
2. Patient is on low-dose dual oral AHA combination therapy (i.e., &#8804;50% maximum
labeled dose of each agent) and has an A1C &#8805;7.0% and &#8804;10.5%.
Note: At Visit 1, patients who have been on a PPAR-&#947; agent (i.e., a TZD) either as
monotherapy or in combination with other oral AHA within the prior 12 weeks, are
not allowed to participate in the study.
e. Patient is a male, or female unlikely to conceive, as indicated by meeting at least one
of the following conditions
1. Patient is a male.
2. Patient is a female of reproductive potential and either agrees to remain abstinent
(if this form of birth control is accepted by local regulatory agencies and review
committees as the sole method of birth control) or use 2 acceptable methods of
birth control within the projected duration of the study.
Note: Acceptable methods of birth control are: intrauterine device (IUD), diaphragm
with spermicide, contraceptive sponge, condom, vasectomy. For the purposes of this
study, use of oral contraceptive pills (OCPs) are permitted but are not to be
considered one of the 2 forms of birth control required.
3. Patient is a female who is not of reproductive potential and therefore eligible to
participate in this study without requiring the use of contraception. A female
patient who is not of reproductive potential is defined as: one who has either
1) reached natural menopause (defined as &#8805;6 months of spontaneous amenorrhea
with serum FSH levels in the postmenopausal range as determined by the
laboratory, or &#8805;12 months of spontaneous amenorrhea in women >45 years,
2) hysterectomy, or bilateral oophorectomy with or without hysterectomy, or
bilateral tubal ligation.
f. Patient understands the study procedures, alternative treatments available, and risks
involved with the study, and voluntarily agrees to participate in the study by giving
written informed consent.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Visit 1/Screening
Glucose Metabolism and Therapy Criteria
a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or patient
is assessed by the investigator as possibly having type 1 diabetes confirmed with a
C-peptide <0.7 ng/mL (0.23 nmol/L).
b. Patient has a history of severe hypoglycemia defined as two or more episodes during
his/her lifetime or one episode within the past year that resulted in hypoglycemic
seizures and/or cerebral impairment (e.g., coma, severe confusion, etc.) or patient has
had hypoglycemia unawareness (i.e., fingerstick glucose <50 mg/dL [2.8 mmol/L]without symptoms) within the past 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified