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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01697657




Registration number
NCT01697657
Ethics application status
Date submitted
28/09/2012
Date registered
2/10/2012
Date last updated
27/01/2017

Titles & IDs
Public title
Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes
Scientific 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
Secondary ID [1] 0 0
NN304-1375
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - insulin detemir
Treatment: Drugs - insulin NPH
Treatment: Drugs - insulin aspart

Experimental: Detemir -

Active comparator: NPH -


Treatment: Drugs: insulin detemir
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2

Treatment: Drugs: insulin NPH
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2

Treatment: Drugs: insulin aspart
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of total self-recorded hypoglycaemic episodes
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Incidence of total major hypoglycaemic episodes
Timepoint [1] 0 0
Secondary outcome [2] 0 0
HbA1c (glycosylated haemoglobin)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
8-point plasma glucose profiles
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Serum glucose profiles
Timepoint [4] 0 0
Secondary outcome [5] 0 0
72-hours glucose profile
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Within-subject variation in home-measured fasting plasma glucose
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Incidence of adverse events
Timepoint [7] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2002
Sample size
Target
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Ashford
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5035 - Ashford
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
Croatia
State/province [1] 0 0
Zagreb
Country [2] 0 0
Denmark
State/province [2] 0 0
Køge
Country [3] 0 0
Denmark
State/province [3] 0 0
Århus C
Country [4] 0 0
Italy
State/province [4] 0 0
Citta' Di Castello
Country [5] 0 0
Italy
State/province [5] 0 0
Perugia
Country [6] 0 0
South Africa
State/province [6] 0 0
Western Cape
Country [7] 0 0
Sweden
State/province [7] 0 0
Linköping
Country [8] 0 0
Sweden
State/province [8] 0 0
Trelleborg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Kolendorf K, Ross GP, Pavlic-Renar I, Perriello G,... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01697657