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

Diabetes Clinical Trial

Official title:

Trial Investigating the Hypoglycaemic Response to Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760448
• Other study ID #: NN304-1449
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2008
• Last updated: January 26, 2017
• Start date: April 2004
• Est. completion date: October 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir

• insulin NPH

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Smeeton F, Shoajee-Moradie F, Jackson N, Westergaard L, Endahl L, Haahr HL, Umpleby M, Russell-Jones D. No Difference in Cognitive Function, Symptons or Counter-regulatory Responses after Induced Hypoglycemia in Subjects with Type 1 Diabetes. ADA 2007 200

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration based on the Edinburgh Hypoglycaemia Scale: autonomic symptoms, neuroglycopenic symptoms and general malaise		From -40 min and until immediately before trial product administration

External Links

•   Clinical Trials at Novo Nordisk