Effect of Januvia on Beta Cell Function in Patients With Diabetes Mellitus

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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 undergo 2 experiments (see description below); a graded hyperglycemic technique and a meal test, prior to randomization and after a 12-wk double-blind study period. The treatment effect will shed light on the magnitude of the beta cell capacity to increase its mass and function.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Sitagliptin Phosphate

Criteria

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:

1. Patient is currently not on an AHA and has a Visit 1 HbA1c ≥6.5% and ≤10%. OR

2. 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