Renal and Peripheral Hemodynamic Function in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Protein kinase C (PKC), an enzyme in the body, has been implicated in the process of diabetic microvascular complications. The purpose of this study will be to evaluate the renal hemodynamic and peripheral vascular effects of PKC inhibition with ruboxistaurin mesylate (an inhibitor of PKC) in patients with Type 1 diabetes mellitus and evidence of early nephropathy. In this pilot study, 21 patients with type 1 diabetes were planned to be randomized to LY333531 or placebo in a 2:1 fashion, after an initial period of testing. After 8 weeks of study drug, patients were retested.

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

Details

• Lead Sponsor: Chromaderm, Inc.
• Collaborator: Heart and Stroke Foundation of Canada
• Treatments: Ruboxistaurin

Criteria

Inclusion Criteria:

• have type 1 diabetes mellitus

• hemoglobin A1C between 6 and 10%

• have evidence of early diabetic renal disease as determined by creatinine clearance more than 80 ml/minute, urine albumin to creatinine ratio of more than 3.0 and urinary albumin levels consistent with the diagnosis of diabetic nephropathy (more than 20 mg/mmol for men and more than 28 mg/mmol for women)

• are without language barrier, cooperative, expected to return for all follow-up visits, and who give informed consent before entering the study's randomization phase and after being informed of the study medications and procedures.

Exclusion Criteria:

• Have poorly controlled diabetes, chronic liver disease, clinical jaundice, and/or elevation of liver-related laboratory results, have chronic renal failure on dialysis, have received a kidney transplant or have a moderate to severe kidney disease, have previous history of myocardial infarction, stroke, claudication or amputation, have cancer and are currently receiving chemotherapy or plan to receive chemotherapy in the next 6 months and woman of childbearing potential despite actively practicing birth control by using a medically accepted device or therapy.

• are being treated or intending to start treatment during the trial with excluded drugs: topical or oral carbonic anhydrase inhibitors and require more than 2 weeks of treatment with drugs known to strongly inhibit cytochrome P450 3A4 (CYP3A4), including but not limited to, delavirdine, fluconazole, itraconazole, indinavir, ketoconazole mibefradil, nelfinavir, ritonavir, and saquinavir.

• consume alcohol, tobacco and nicotine products within 48 hours before the study and have any condition that, in the investigator's opinion, would preclude meaningful participation in the study, including, but not limited to, abnormal laboratory values the investigator considers clinically significant, patients who are poor medical or psychiatric risks for treatment with an investigational drug, patients who are unlikely to complete the study.

• suspected or proven to have a kidney disease other than diabetic related albuminuria and/or renal insufficiency.