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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
This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).
Trial website
https://clinicaltrials.gov/study/NCT00184665
Trial related presentations / publications
Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med. 2008 Apr;25(4):442-9. doi: 10.1111/j.1464-5491.2007.02407.x.
Gschwend MH, Aagren M, Valentine WJ. Cost-effectiveness of insulin detemir compared with neutral protamine Hagedorn insulin in patients with type 1 diabetes using a basal-bolus regimen in five European countries. J Med Econ. 2009 Jun;12(2):114-23. doi: 10.3111/13696990903080344.
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/study/NCT00184665