Clinical trial NCT01697657: Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes
Official title: A Randomised, Open Label, Cross-over, Multi-centre, Multinational Trial Comparing the Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir and NPH Insulin in Well Controlled Subjects With Type 1 Diabetes on a Basal-bolus Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Fasting c-peptide below lower limit of normal fasting range
* Duration of type 1 diabetes for at least 12 months
* Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
* HbA1c maximum 9.0% (using Biorad Variant method)
* Able and willing to perform self-monitoring of blood glucose
* Basal insulin requirement at least 30% of the total daily insulin dose
* BMI (body Mass Index) maximum 35 kg/m\^2

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment
* Total daily insulin dose above 1.4 IU/kg/day
* Known unawareness of hypoglycaemia
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Uncontrolled, treated/untreated hypertension
* Known or suspected allergy to trial product or related products

Primary outcomes:
measure: Incidence of total self-recorded hypoglycaemic episodes
Secondary outcomes:
measure: Incidence of total major hypoglycaemic episodes
measure: HbA1c (glycosylated haemoglobin)
measure: 8-point plasma glucose profiles
measure: Serum glucose profiles
measure: 72-hours glucose profile
measure: Within-subject variation in home-measured fasting plasma glucose
measure: Incidence of adverse events
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Ashford
country: Australia
facility: Novo Nordisk Investigational Site
city: Box Hill
country: Australia
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Køge
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Citta' Di Castello
country: Italy
facility: Novo Nordisk Investigational Site
city: Perugia
country: Italy
facility: Novo Nordisk Investigational Site
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Trelleborg
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kolendorf K, Ross GP, Pavlic-Renar I, Perriello G, Philotheou A, Jendle J, Gall MA, Heller SR. Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes. Diabet Med. 2006 Jul;23(7):729-35. doi: 10.1111/j.1464-5491.2006.01862.x.