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
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Kidney Diseases
Urologic Diseases processed this record on March 26, 2015