Signaling Mechanisms and Vascular Function in Diabetes Mellitus

NCT00761852 | Completed Phase 2 DMC

• 1 other identifier: 1999-P-003331Ruboxistaurin
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ruboxistaurin is being tested to see if it is effective in treating certain diabetic complications, such as diseases of the blood vessels.

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• To test the hypothesis that activation of protein kinase Cß (PKCß) impairs vascular reactivity in patients with diabetes mellitus

  one testing visit every 4 weeks for 8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Ruboxistaurin

Drug: Ruboxistaurin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ruboxistaurin DRUG

32 mg daily for 2 weeks

Also known as: LY-333531

1

Placebo DRUG

1 tab po QD for 2 weeks

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with diabetes mellitus will be eligible if they are receiving dietary treatment for hyperglycemia, sulfonylureas, metformin or insulin

You may not qualify if:

• Any diabetic subject with a HgbA1C level of \<7% or \>11%
• Evidence of atherosclerosis
• symptoms of angina
• symptoms of claudication
• symptoms of cerebrovascular ischemia
• findings of arterial occlusive disease, as would be suggested by decreased pulses, asymmetric blood pressure, bruits or reduced limb pressure measurements
• hypertension defined as a systolic blood pressure \> = 150 mmHg and a diastolic blood pressure \>= 95 mmHg; (allowable blood pressure medications for diabetic subjects include calcium channel blockers, alpha and beta adrenergic blockers, and diuretics)
• hypercholesterolemia, defined as total cholesterol levels greater than 75th percentile for age and sex and LDL cholesterol levels \>130mg/dL.
• renal insufficiency (serum creatinine \>1.5 mg/dL for men; \>1.2 mg/dL for women)
• hepatic dysfunction defined as liver enzyme abnormalities \> two times the upper limit of normal
• chronic pulmonary disease
• congestive heart failure
• pregnancy (or subjects planning to become pregnant);
• history of cigarette smoking within the last five years;
• history of clinically significant coronary artery or cerebrovascular disease (defined as MI or stroke within 6 months, or presence of unstable angina)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Eli Lilly and Company: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

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

• Mark A Creager, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 1999
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 30, 2008

Record last verified: 2008-09