Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

This study has been completed.
Information provided by:
Steno Diabetes Center Identifier:
First received: April 4, 2006
Last updated: NA
Last verified: April 1999
History: No changes posted
The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months

Condition Intervention Phase
Diabetic Nephropathy
Drug: nisoldipine
Drug: lisinopril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • change in glomerular filtration rate from study start to study end

Secondary Outcome Measures:
  • blood pressure response
  • change in urinary albumin excretion rate

Estimated Enrollment: 52
Study Start Date: March 1993
Estimated Study Completion Date: April 1999

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diabetic nephropathy, type 1 diabetes, hypertension

Exclusion Criteria:

  • child bearing potential, non-diabetic kidney disease, malignancy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00311870

Steno Diabetes Center
Gentofte, Denmark, DK-2820
Sponsors and Collaborators
Steno Diabetes Center
Principal Investigator: Peter Rossing, MD Steno Diabetes Center
Study Chair: Hans-Henrik Parving, MD Steno Diabetes Center
  More Information

Publications: Identifier: NCT00311870     History of Changes
Other Study ID Numbers: KA 92126 
Study First Received: April 4, 2006
Last Updated: April 4, 2006
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Cardiotonic Agents
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protease Inhibitors
Protective Agents
Vasodilator Agents processed this record on May 26, 2016