Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes

Novo Nordisk A/S71 enrolled

Overview

This trial is conducted in Europe. A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin detemirDRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes * Current intensified insulin treatment * Injection of insulin Semilente®MC at bedtime for at least 6 weeks * BMI maximum 32 kg/m\^2 * HbA1c \> 5.5 % and \< 12.0 % Exclusion Criteria: * Current treatment with premixed insulin(s) * Impaired hepatic or renal function * Recurrent major hypoglycaemia

Locations (2)

Novo Nordisk Investigational Site

Berlin, Germany

Novo Nordisk Investigational Site

Hanover, Germany

Outcomes

Primary Outcomes

Fasting plasma glucose

Time frame: after 16 and 32 weeks, respectively

Secondary Outcomes

Adverse events

HbA1c results at the end of each treatment period

Blood glucose

Standard Laboratory Safety Parameters

Hypoglycaemia

Data from ClinicalTrials.gov

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