Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes

Novo Nordisk A/S520 enrolled

Overview

This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

520

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin detemirDRUG

insulin aspartDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes for more than 1 year * Subject treated by any kind of insulin regimen and whatever the number of injections * HbA1c = 7.5% and = 10% Exclusion Criteria: * Type 2 diabetes * Treatment by oral anti-diabetic drugs * Severe medical conditions

Locations (3)

Novo Nordisk Investigational Site

Aalst, Belgium

Novo Nordisk Investigational Site

Lille, France

Novo Nordisk Investigational Site

Luxembourg, Luxembourg

Outcomes

Primary Outcomes

Mean HbA1c

Time frame: after 4 months of insulin detemir treatment

Secondary Outcomes

HbA1c

Adverse events

Insulin dose requirements during initial 4 months of treatment and during 3 months extension

Weight

Blood glucose

Hypoglycaemia

Data from ClinicalTrials.gov

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