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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/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
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Scientific title
2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.
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Secondary ID [1]
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NN304-1595
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Diabetes Mellitus, Type 1
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - insulin detemir
Treatment: Drugs - insulin NPH
Treatment: Drugs - insulin aspart
Treatment: Drugs: insulin detemir
Treatment: Drugs: insulin NPH
Treatment: Drugs: insulin aspart
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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HbA1c
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Assessment method [1]
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Timepoint [1]
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after a two-year trial period
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Secondary outcome [1]
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Adverse events
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Body weight
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Antibodies
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Body composition
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Blood glucose
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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Hypoglycaemia
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Assessment method [6]
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Timepoint [6]
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Eligibility
Key inclusion criteria
- Type 1 diabetes
- Currently on basal-bolus regimen
- BMI = 35.0 kg/m2
- HbA1c =11.0%
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Cardial problems
- Uncontrolled hypertension
- Impaired hepatic or renal function
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Accrual to date
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Final
501
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - St Leonards
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - Hobart
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Recruitment hospital [3]
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Novo Nordisk Investigational Site - Melbourne
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Recruitment hospital [4]
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Novo Nordisk Investigational Site - Darlinghurst
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Recruitment hospital [5]
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Novo Nordisk Investigational Site - Stones Corner
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Recruitment hospital [6]
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Novo Nordisk Investigational Site - Woodville
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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2010 - Darlinghurst
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment postcode(s) [6]
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4120 - Stones Corner
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Recruitment postcode(s) [7]
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5011 - Woodville
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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Ciudad Autonoma de Bs As
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Country [3]
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Argentina
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State/province [3]
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Ciudad Autónoma de BsAs
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Country [4]
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Argentina
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State/province [4]
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Mar del Plata
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Country [5]
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Bulgaria
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State/province [5]
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Plovdiv
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Country [6]
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Bulgaria
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State/province [6]
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Sofia
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Country [7]
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Croatia
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State/province [7]
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Zagreb
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Country [8]
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India
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State/province [8]
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Tamil Nadu
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Country [9]
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India
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State/province [9]
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Chennai
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Country [10]
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India
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State/province [10]
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Hyderabad
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Country [11]
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India
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State/province [11]
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Mumbai
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Country [12]
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Macedonia, The Former Yugoslav Republic of
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State/province [12]
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Skopje
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Country [13]
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Malaysia
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State/province [13]
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Cheras
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Country [14]
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Malaysia
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State/province [14]
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Kota Bharu, Kelantan
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Country [15]
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Romania
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State/province [15]
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Bucharest
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Country [16]
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South Africa
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State/province [16]
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Gauteng
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Country [17]
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South Africa
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State/province [17]
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Western Cape
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Country [18]
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South Africa
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State/province [18]
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Bloemfontein
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Country [19]
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Turkey
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State/province [19]
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Bornova-IZMIR
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Country [20]
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Turkey
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State/province [20]
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Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00184665
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Global Clinical Registry (GCR, 1452)
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Address
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Novo Nordisk A/S
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00184665
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