Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria

NCT00557518 | Terminated Phase 2

• 1 other identifier: ALT-711-0424
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 6

Brief Summary

Based upon the preclinical evidence in models of diabetic nephropathy under conditions approximating both type I and II diabetes, treatment with alagebrium appears to have favorable and advantageous effects on the biochemical, structural, pathological and functional hallmarks of diabetic nephropathy. The renoprotective effects of alagebrium in preclinical models favor the evaluation of this drug in patients with type I diabetes.

Conditions

Diabetes Mellitus, Type 1; Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in albumin excretion rate (µg/min)

  24 weeks

Secondary Outcomes (1)

• Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations

  24 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Alagebrium

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Alagebrium DRUG

200 mg bid

Also known as: ALT-711

1

Placebo DRUG

bid

2

Eligibility Criteria

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

You may qualify if:

• Insulin-dependent type 1 diabetes
• Age 18-65 years
• Diagnosis of established microalbuminuria
• Blood pressure \<140 mm Hg, diastolic blood pressure \<90 mm Hg
• HbA1c \<10%

You may not qualify if:

• Body mass index \>40 kg/m2
• Cardiovascular event within 6 months prior to screening
• History of acute myocardial infarction within 12 months prior to screening
• Serum creatinine \>1.5 mg/dL
• Receiving chronic nonsteroidal anti-inflammatory therapy
• Receiving antihypertensive therapy except for angiotensin converting enzyme inhibitors or angiotensin receptor blockers
• Any significant systemic illnesses,medical conditions or abnormal laboratory values

Sponsors & Collaborators

• Synvista Therapeutics, Inc: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (6)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

International Diabetes Institute

Caulfield, Victoria, 3162, Australia

Location

Dept. of Clinical and Biomedical Science Myers House

Geelong, Victoria, 3220, Australia

Location

Austin Health

Heidelburg, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Steno Diabetes Center

Gentofte Municipality, DK-2820, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Nephropathies

Interventions

alagebrium

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Officials

• Mark E Cooper, MBBS, PhD

  Baker Heart Research Institute, Melbourne, Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 30, 2009

Record last verified: 2009-01

Locations

AU (5); DK (1)