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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

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