Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

Novo Nordisk A/S501 enrolled

Overview

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin 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 insulin antibodies and side effects).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

501

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: * Type 1 diabetes * Currently on basal-bolus regimen * BMI = 35.0 kg/m2 * HbA1c =11.0% Exclusion Criteria: * Proliferative retinopathy or maculopathy * Recurrent major hypoglycaemia * Cardial problems * Uncontrolled hypertension * Impaired hepatic or renal function

Locations (29)

Outcomes

Primary Outcomes

HbA1c

Time frame: after a two-year trial period

Secondary Outcomes

Adverse events

Body weight

Antibodies

Body composition

Blood glucose

Hypoglycaemia

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.