Status:
COMPLETED
Effect of Januvia on Beta Cell Function in Patients With Diabetes Mellitus
Lead Sponsor:
Sheba Medical Center
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100 mg/day on the insulin secretion capacity of beta cells. Patients who meet the study enrollment criteria will...
Detailed Description
Study design and duration: This will be an Israeli three center study. Study drug: Sitagliptin 100 mg. The study will be a double blind, randomized two arms parallel group study. The duration of the s...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient has T2DM diagnosed within the past 5 years
- Patient is \>18 and \<65 years of age
- Patient is not pregnant, breast feeding and unlikely to conceive
- Patient understands the study procedures, and agrees to participate in the study by giving written informed consent
- Patient meets one of the following criteria:
- Patient is currently not on an AHA and has a Visit 1 HbA1c ≥6.5% and ≤10%. OR
- Patient is currently on AHA monotherapy or low dose (i.e. ≤50% maximum labeled dose of each agent) oral combination therapy and has a Screening/Visit 1 HbA1c ≥6.5% and ≤9.5%.
- At visit 2, patient has a HbA1c of ≥6.5% and ≤10%
- Exclusion Criteria:
- Patient has type 1 diabetes mellitus
- Patient required insulin therapy within 12 weeks of Visit 1. Note: patients who received a brief period of insulin treatment (e.g., several days during a hospitalization) and who are no longer requiring insulin treatment may participate
- Patient is currently or within 12 weeks of Visit 1 taking a TZD agent as monotherapy or in combination
- Patient is currently or within 12 weeks of Visit 1 taking Byetta.
- Patient is on corticosteroids
- Patient has a history of malignancy ≤5 years prior to signing informed consent, or \>5 years without documentation of remission/cure Exception: Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Melanoma, leukemia, lymphoma and myeloproliferative disorders of any duration are excluded -Patient is on chemotherapy
- Patient received another investigational drug in the last 12 weeks.
- Patients with concomitant liver disease and or AST \> 3 fold upper limit of normal
- Patients with kidney disease or CR\>1.4 mg/dl
- Patients with anemia ( Hb \<11 gr in male 10 gr in female)
- Patient with active vascular disease (coronary, peripheral or cerebrovascular)
- Patient has poorly controlled hypertension defined as systolic blood pressure \>160 mm Hg or diastolic \>95 mm Hg
- Proliferative retinopathy
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00425490
Start Date
January 1 2007
End Date
July 1 2009
Last Update
September 23 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheba_Medical_Center
Tel Litwinsky, Israel