Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

Novo Nordisk A/S598 enrolled

Overview

This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

598

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin detemirDRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

insulin aspartDRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

insulin NPHDRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes for at least 12 months * Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months * BMI below or equal to 35 kg/m\^2 * HbA1c below or equal to 12% Exclusion Criteria: * Proliferative retinopathy or maculopathy requiring acute treatment * Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator) * Subjects with known hypoglycaemic unawareness as judged by the Investigator

Locations (75)

Outcomes

Primary Outcomes

HbA1c (glycosylated haemoglobin)

Secondary Outcomes

Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)

8-point blood glucose profiles

Incidence of self-recorded hypoglycaemic episodes

Incidence of adverse events

Data from ClinicalTrials.gov

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