Comparison of Insulin Detemir and NPH With Respect to Lowering the Blood Sugar and Symptoms Experienced by Type 1 Diabetics During Hypoglycaemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial is conducted in UK. The aim of this clinical trial is to investigate lowering the blood sugar and symptoms experienced during hypoglycaemia

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03220425

Diabetes Mellitus, Type 1

COMPLETED PHASE3

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

NCT01486940

Diabetes Diabetes Mellitus, Type 1

COMPLETED PHASE3

Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes

NCT01697657

Diabetes Diabetes Mellitus, Type 1

COMPLETED PHASE3

Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

NCT00184665

Diabetes Diabetes Mellitus, Type 1

COMPLETED PHASE3

Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes

NCT00435019

Diabetes Diabetes Mellitus, Type 1

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin detemir

Intervention Type DRUG

insulin NPH

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signed and dated informed consent obtained before any trial-related activities.
* Type 1 diabetes
* Treatment with insulin for minimum three months
* Duration of diabetes for more than 12 months
* Body Mass Index (BMI) less than 30 kg/m2
* HbA1c equal to or greater than 10 % based on analysis from central laboratory

Exclusion Criteria

* Participation in any other clinical trial involving other investigational products within the last three months
* Current treatment with insulin in a daily dose above 100 U
* Episode of symptomatic hypoglycaemia, or a capillary plasma glucose value of less than 3.5 mmol/L in the past two weeks
* Hypoglycaemic unawareness or severe autonomic neuropathy
* Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
* Current treatment with oral antidiabetic drugs
* Impaired hepatic function measured as ALAT of more than two times the upper reference limit
* Impaired renal function measured as creatinine of more than 150 micromol/L (1.7 mg/dL)
* Cardiac problems defined as decompensated heart failure (NYHA class III and IV) at any time and/or angina pectoris and/or myocardial infarction within the last 12 months
* Known or suspected allergy to trial product or related products
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Blood donation of more than 500 mL within the last three months
* Any condition that the Investigator and/or the Sponsor feels would interfere with study participation or evaluation of results
* Pregnancy or intention of becoming pregnant, breast-feeding or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods
* Previous participation in this trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No