Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

Novo Nordisk A/S447 enrolled

Overview

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

447

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin detemirDRUG

insulin glargineDRUG

insulin aspartDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes for at least 12 months * Current treatment with basal-bolus insulin regimen for more than or equal to 3 months * HbA1c less than or equal to 11.0% Exclusion Criteria: * Proliferative retinopathy or maculopathy * Recurrent major hypoglycaemia * Impaired hepatic or renal function * Cardiac problems or uncontrolled hypertension

Locations (81)

Outcomes

Primary Outcomes

HbA1c

Time frame: after 1 year trial period

Secondary Outcomes

Adverse events

Body weight

Hypoglycemia

Blood glucose

Insulin Treatment Satisfaction

Data from ClinicalTrials.gov

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