A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control - ND
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
- Registration Number
- EUCTR2007-003548-32-IT
- Lead Sponsor
- MERCK SHARP DOHME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
a.Patient has type 2 diabetes mellitus (T2DM).
b.Patient has moderate or severe renal insufficiency as indicated by an estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2 and is not likely to require dialysis throughout the duration of the study.
Note: Glomerular filtration rate is estimated using the Modification of Diet in Renal Disease (MDRD) formula (see Appendix 6.8).
c.Patient is ≥ 30 years of age on day of signing informed consent.
d.Patient is unlikely to conceive, as indicated by at least one ?yes? answer to the following questions:
1)Patient is a male.
2)Patient is a surgically sterilized female.
3)Patient is a postmenopausal female ≥ 45 years of age with > 2 years since last menses.
4)Patient is a non-sterilized, premenopausal female and agrees to abstain from heterosexual activity or to use an adequate method of contraception.
Note: Acceptable methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
e.Patient understands the study procedures, alternative treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.a.Patient has type 2 diabetes mellitus (T2DM).
b.Patient has moderate or severe renal insufficiency as indicated by an estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2 and is not likely to require dialysis throughout the duration of the study.
Note: Glomerular filtration rate is estimated using the Modification of Diet in Renal Disease (MDRD) formula (see Appendix 6.8).
c.Patient is ≥ 30 years of age on day of signing informed consent.
d.Patient is unlikely to conceive,
f.Patient is likely to be able to complete the study.1)Patient is currently not on an antihyperglycemic agent (off therapy for ≥12 weeks) and has a Visit 1 HbA1c ≥7% and ≤9%.
Are the trial subjects under 18? yes
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.
b.Patient is losing weight in a weight loss program and is not in the maintenance phase (defined as <2 kg weight loss in 2 months).
c.Patient intends to be involved in weight loss intervention outside that prescribed by the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: 1)Objective: After 54 weeks, to assess the effect of sitagliptin compared with glipizide on HbA1c.<br> 2)Objective: After 54 weeks, to assess the effect of sitagliptin compared with<br> glipizide on the incidence of hypoglycemic events.<br> 3)Objective: After 54 weeks, to assess the safety and tolerability of sitagliptin.<br> ;Primary end point(s): HbA1c;<br> Secondary Objective: 1)Objective: After 54 weeks, to assess the effect of sitagliptin compared with glipizide on body weight.<br> 2)Objective: After 54 weeks, to assess the effect (change from baseline) of sitagliptin on HbA1c.<br> 3)Objective: After 54 weeks, to assess the effect of sitagliptin compared with glipizide on FPG.<br>
- Secondary Outcome Measures
Name Time Method