Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

Condition(s) targeted: Diabetic Nephropathy

Intervention: nisoldipine (Drug); lisinopril (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Steno Diabetes Center

Official(s) and/or principal investigator(s):
Peter Rossing, MD, Principal Investigator, Affiliation: Steno Diabetes Center
Hans-Henrik Parving, MD, Study Chair, Affiliation: Steno Diabetes Center

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

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: change in glomerular filtration rate from study start to study end

Secondary outcome:

blood pressure response

change in urinary albumin excretion rate

Detailed description:

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Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- diabetic nephropathy, type 1 diabetes, hypertension

Exclusion Criteria:

- child bearing potential, non-diabetic kidney disease, malignancy

Steno Diabetes Center, Gentofte DK-2820, Denmark

Starting date: March 1993
Ending date: April 1999
Last updated: April 4, 2006