IRB Number:

07-006797

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This research study is designed to provide additional information on the safety and tolerability of vildagliptin and sitagliptin when used in patients with type 2 diabetes and severe renal insufficiency.

Who is Eligible to Participate in the Study?

1. Age in the range of 18-85 years inclusive at visit 1
2. Patients with type 2 diabetes mellitus either untreated (defined as not taking anti-diabetic therapy for at least 8 weeks prior to visit 1) or treated with anti-diabetic therapy defined as sulfonylurea, TZDs, insulin, and metiglinides as monotherapy or combination therapy for at least 8 weeks prior to visit 1
3. Patients treated with anti-diabetic therapy must be on a stable dose for the past 4 weeks prior to visit 1 (stable insulin therapy is defined as ± 20% of total daily units)
4. GFR of < 30 mL/min/ 1.73 m2 at visit 1
5. HbA1c of ≥ 6.5 and ≤ 10% at visit 1
6. Body mass index (BMI) 18-42 kg/m2 at visit 1
7. Male, non-fertile female or female of childbearing potential using a medically approved birth control method by the country health authorities that may include:
-- A non-fertile female is defined as: postmenopausal (12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mLU/m); 6 weeks post bilateral oophorectomy with or without hysterectomy; post hysterectomy; or sterilized by tubal ligation
-- A female of childbearing potential is defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means
-- Medically approved birth control methods may include: hormonal contraceptives, intrauterine device, and double-barrier contraception. Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
-- Reliable contraception should be maintained throughout the study
8. Agreement to continue their current diet/exercise regimen and sulfonylurea, TZD, insulin or metiglinide therapy throughout the duration of the study or to remain untreated if patient is not taking anti-diabetic therapy, unless otherwise instructed by the trial?s physician
9. Written informed consent to participate in the study and ability to comply with all study requirements

Minimum Age:

18

Maximum Age:

85

What is Involved With this Study?

Screening
You will have a physical exam and routine blood tests to determine if you are eligible to take part in this study. Your Glomerular filtration rate (GFR) will need to be <30 mL/min.

Treatment
Patients will be randomized to receive either vildagliptin or sitagliptin in addition to continuing their current anti-diabetic therapy (if on treatment at study entry) for 24 weeks along with blood and urine tests.

How long will the Study run?

The study procedures will last 24 weeks.

Who can I Contact for Additional Information on this Trial?

Shirley Jennison
Phone: (507) 255-0231
E-mail: jennison.shirley@mayo.edu

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 01/21/2009