Clinical trial NCT00760448: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration based on the Edinburgh Hypoglycaemia Scale: autonomic symptoms, neuroglycopenic symptoms and general malaise
timeFrame: From -40 min and until immediately before trial product administration
Secondary outcomes:
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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)
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.