Glargine Versus NPH in Patients With Chronic Kidney Disease

PHASE4CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Type 2 Diabetes MellitusChronic Kidney Disease
Interventions
DRUG

Glargine insulin

The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained

DRUG

NPH insulin

The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained.

Trial Locations (1)

05410001

University of Sao Paulo, São Paulo

All Listed Sponsors
lead

University of Sao Paulo General Hospital

OTHER

NCT02451917 - Glargine Versus NPH in Patients With Chronic Kidney Disease | Biotech Hunter | Biotech Hunter