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

NCT00297401 | Completed Phase 3

• 2 other identifiers: 8023B7A-CA-S003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

• Primary outcomes will be the change in proteinuria, pre- and post-treatment with ruboxistaurin.

  Baseline and 8 weeks

• Change in the renal and peripheral pressor response to hyperglycemia pre and post treatment with ruboxistaurin

  Baseline and 8 weeks

• Change in the renal and peripheral pressor response to Angiotensin II pre and post-treatment with ruboxistaurin.

  Baseline and 8 weeks

Secondary Outcomes (1)

• Secondary analyses will consist of the change in endothelial function and vascular compliance pre- and post-treatment with ruboxistaurin.

  Baseline and 8 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: ruboxistaurin

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

ruboxistaurin DRUG

32 mg, QD, PO, up to 8 weeks

Also known as: Arxxant, LY333531

1

placebo DRUG

QD, PO, up to 8 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chromaderm, Inc.: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physcian.

Toronto, Ontario, Canada

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

ruboxistaurin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Karl Beutner

  Chromaderm, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: March 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 29, 2016

Record last verified: 2016-08

Locations

CA (1)