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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00184665




Registration number
NCT00184665
Ethics application status
Date submitted
13/09/2005
Date registered
16/09/2005
Date last updated
27/01/2017

Titles & IDs
Public title
Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes
Scientific title
2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.
Secondary ID [1] 0 0
NN304-1595
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
after a two-year trial period
Secondary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Body weight
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Antibodies
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Body composition
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Blood glucose
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Hypoglycaemia
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
* Type 1 diabetes
* Currently on basal-bolus regimen
* BMI = 35.0 kg/m2
* HbA1c =11.0%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Proliferative retinopathy or maculopathy
* Recurrent major hypoglycaemia
* Cardial problems
* Uncontrolled hypertension
* Impaired hepatic or renal function

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
Parallel
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
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
501
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Hobart
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Darlinghurst
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Stones Corner
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
4120 - Stones Corner
Recruitment postcode(s) [7] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autonoma de Bs As
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad Autónoma de BsAs
Country [4] 0 0
Argentina
State/province [4] 0 0
Mar del Plata
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Plovdiv
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
Croatia
State/province [7] 0 0
Zagreb
Country [8] 0 0
India
State/province [8] 0 0
Tamil Nadu
Country [9] 0 0
India
State/province [9] 0 0
Chennai
Country [10] 0 0
India
State/province [10] 0 0
Hyderabad
Country [11] 0 0
India
State/province [11] 0 0
Mumbai
Country [12] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [12] 0 0
Skopje
Country [13] 0 0
Malaysia
State/province [13] 0 0
Cheras
Country [14] 0 0
Malaysia
State/province [14] 0 0
Kota Bharu, Kelantan
Country [15] 0 0
Romania
State/province [15] 0 0
Bucharest
Country [16] 0 0
South Africa
State/province [16] 0 0
Gauteng
Country [17] 0 0
South Africa
State/province [17] 0 0
Western Cape
Country [18] 0 0
South Africa
State/province [18] 0 0
Bloemfontein
Country [19] 0 0
Turkey
State/province [19] 0 0
Bornova-IZMIR
Country [20] 0 0
Turkey
State/province [20] 0 0
Istanbul

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


Results not provided in https://clinicaltrials.gov/study/NCT00184665