Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Broadmeadow, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed and dated informed consent obtained before any trial-related activities
Type 1 diabetes diagnosed and classified according to aetiology
Duration of type 1 diabetes equal to or more than 12 months
Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
Able and willing to perform self-blood glucose monitoring

Exclusion criteria

Proliferative retinopathy
Total basal insulin dose of more than 100 IU per day
Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
Known unawareness of hypoglycaemia
Previous treatment with insulin detemir

Treatment and study plan

insulin detemir

Drug

NPH insulin

Drug

Primary outcomes

The change in the level of glycosylated haemoglobin(HbA1c)

Time frame: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.

Important dates

Study start: 2001
Primary completion: 2001
Study completion: 2001
First posted: Jul 18, 2017
Registry last updated: Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed