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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01697657
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01697657