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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

insulin detemir

insulin NPH

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration based on the Edinburgh Hypoglycaemia Scale: autonomic symptoms, neuroglycopenic symptoms and general malaise

Secondary Outcome Measures

Full Information

NCT ID

NCT00760448

First Posted

September 25, 2008

Last Updated

January 26, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT00760448

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

insulin detemir

Intervention Type

Drug

Intervention Name(s)

insulin NPH

Primary Outcome Measure Information:

Title

Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration based on the Edinburgh Hypoglycaemia Scale: autonomic symptoms, neuroglycopenic symptoms and general malaise

Time Frame

From -40 min and until immediately before trial product administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

Citation

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 2007; 56 (Suppl. 1): A168 (634-P)

Results Reference

result

PubMed Identifier

19707744

Citation

Smeeton F, Shojaee Moradie F, Jones RH, Westergaard L, Haahr H, Umpleby AM, Russell-Jones DL. Differential effects of insulin detemir and neutral protamine Hagedorn (NPH) insulin on hepatic glucose production and peripheral glucose uptake during hypoglycaemia in type 1 diabetes. Diabetologia. 2009 Nov;52(11):2317-23. doi: 10.1007/s00125-009-1487-4. Epub 2009 Aug 26.

Results Reference

derived

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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