A Phase IIb/III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Dose-Range Finding Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin. - ND
- Conditions
- Type 2 Diabetes Mellitus With Inadequate Glycemic Control on InsulinMedDRA version: 9.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus
- Registration Number
- EUCTR2008-002121-36-IT
- Lead Sponsor
- MERCK & CO., INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 724
Patient has type 2 diabetes mellitus (T2DM).
b. Patient is ≥21 and ≤70 years of age on day of signing informed consent.
c. Patient meets one of the following criteria as indicated by a yes answer to one of
the following:
Patient is currently on LANTUS insulin at a stable dose of ≥15 units/day, either
alone or in combination with metformin monotherapy at a dose of ≥1500 mg/day, for
at least 6 weeks and has a Visit 1/Screening Visit HbA1c ≥7.5% and ≤11.0%
OR
Patient is in 1 of the following 4 categories and based upon review of the patient?s
current diet, medical regimen, and Visit 1/Screening Visit HbA1c, patient is
considered by the investigator as likely to meet Visit 4/Week -2 inclusion criterion of
HbA1c ≥7.5% and ≤11.0% after a 6-week dose stable period on LANTUS (at a dose
of ≥15 units/day):
1) Patient is currently on any injectable insulin(s) (other than LANTUS alone) at a
stable dose of ≥15 units/day, either alone OR in combination with metformin
monotherapy at a dose of ≥1500 mg/day, for at least 6 weeks and has a
Visit 1/Screening Visit HbA1c ≥7.5% and ≤11.0%
2) Patient is currently on any injectable insulin(s) at a stable dose of ≥15 units/day in
combination with metformin monotherapy at a dose of <1500 mg/day OR another
oral monotherapy agent at any dose except a TZD (e.g., pioglitazone or
rosiglitazone), for at least 6 weeks and has a Visit 1/Screening Visit HbA1c
≥7.0% and ≤10.5%
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
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).
Note: Only patients assessed by the investigator as possibly having type 1 diabetes
should have C-peptide measured at Visit 1/Screening Visit.
b. Patient received more than 1 week of dosing of TZD therapy (e.g., pioglitazone or
rosiglitazone) or injectable incretin-based therapy (e.g., Byetta) within the prior 8
weeks.
c. Patient has had two or more episodes during their lifetime or more than one episode
within the past year that resulted in hypoglycemic seizures, comas or
unconsciousness.
Patients Requiring Specific Treatments
d. Hypersensitivity or contraindication to LANTUS insulin.
Patient is on a weight loss program and is not in the maintenance phase, or patient is
taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within
8 weeks of Visit 1/Screening Visit.
f. Patient has received treatment with an investigational drug within the prior 3 months
or is currently participating or planning to participate in another clinical trial.
g. Patient is on or likely to require treatment with warfarin or warfarin-like
anticoagulants, digoxin, or any other medication with a narrow therapeutic index
(refer to Appendix 6.4).
h. Patient is on or likely to require treatment with immunosuppressive/
immunomodulating agents (e.g., cyclosporine, methotrexate, etanercept) or patient is
on or likely to require treatment of ≥14 consecutive days or repeated courses of
pharmacologic doses of systemic (oral, injectable/parenteral) or ocular
corticosteroids, during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method