Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

Novo Nordisk A/S114 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin detemirDRUG

insulin NPHDRUG

insulin aspartDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Duration of type 1 diabetes for at least 12 months * BMI below 35 kg/m2 * HbA1c between 7.0-12.0% * Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months * Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator Exclusion Criteria: * Known or suspected allergy to trial product or related products * Previous participation in this trial * Receipt of any investigational products within the last 2 months prior to this trial * Drug or alcohol dependence * Pregnancy, breast-feeding or intention of becoming pregnant

Locations (18)

Novo Nordisk Investigational Site

Amersfoort, Netherlands

Novo Nordisk Investigational Site

Apeldoorn, Netherlands

Outcomes

Primary Outcomes

HbA1c

Time frame: after 26 weeks of treatment

Secondary Outcomes

Plasma glucose profiles

Change in body weight

Quality of Life

Incidence of adverse events

Incidence of hypoglycaemic episodes

Data from ClinicalTrials.gov

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