DiabetesPhase 3NCT00184665
Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes
A Phase 3 study testing insulin detemir, insulin NPH and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 29 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin detemir, insulin NPH and insulin aspart
- How many people
- 501 participants
- Where
- 29 sitesin 10 countries
- Study dates
- Jun 2004to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Currently on basal-bolus regimen
- BMI = 35.0 kg/m2
- HbA1c =11.0%
Who cannot join
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Cardial problems
- Uncontrolled hypertension
- Impaired hepatic or renal function
Trial locations and contacts
29 sites in 10 countries.
29 sites in 10 countries
Australia7 sites
Novo Nordisk Investigational Site
Darlinghurst, 2010
Novo Nordisk Investigational Site
Hobart, Tasmania, 7000
Novo Nordisk Investigational Site
Melbourne, Victoria, 3004
Novo Nordisk Investigational Site
Melbourne, 3000
Novo Nordisk Investigational Site
St Leonards, New South Wales, 2065
Novo Nordisk Investigational Site
Stones Corner, 4120
Novo Nordisk Investigational Site
Woodville, 5011
Argentina4 sites
Novo Nordisk Investigational Site
Buenos Aires
Novo Nordisk Investigational Site
Ciudad Autonoma de Bs As, C1405CWB
Novo Nordisk Investigational Site
Ciudad Autónoma de BsAs, C1406FWY
Novo Nordisk Investigational Site
Mar del Plata, B7602CBM
India4 sites
Novo Nordisk Investigational Site
Chennai, 600-013
Novo Nordisk Investigational Site
Hyderabad, 600034
Novo Nordisk Investigational Site
Mumbai, 400 0067
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, 632004
South Africa4 sites
Novo Nordisk Investigational Site
Bloemfontein, 27 51
Novo Nordisk Investigational Site
Cape Town, Western Cape, 27 21
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2193
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 27 11
Bulgaria2 sites
Novo Nordisk Investigational Site
Plovdiv, 4002
Novo Nordisk Investigational Site
Sofia, 1431
Malaysia2 sites
Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
Romania2 sites
Novo Nordisk Investigational Site
Bucharest, 020042
Novo Nordisk Investigational Site
Bucharest, 020475
Turkey (Türkiye)2 sites
Novo Nordisk Investigational Site
Bornova-IZMIR, 35100
Novo Nordisk Investigational Site
Istanbul, 34390
About this study
Official title: 2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.
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).
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin detemir, insulin NPH, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin detemirDrug
insulin NPHDrug
insulin aspartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after a two-year trial period
Secondary outcomes (6)
Adverse events
Body weight
Antibodies
Body composition
Blood glucose
Hypoglycaemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184665
- Sponsor's protocol ID
- NN304-1595
- Status last verified
- Jan 2017
- First submitted
- 13 Sep 2005
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18387078Gschwend 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.
PubMed 19545216
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT00184665
- Acronym / sponsor ID
- NN304-1595
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes
- Currently on basal-bolus regimen
- BMI = 35.0 kg/m2
- HbA1c =11.0%
Key exclusion criteria (5 listed)
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Cardial problems
- Uncontrolled hypertension
- Impaired hepatic or renal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin detemir | Drug | – |
| insulin NPH | Drug | – |
| insulin aspart | Drug | – |
Primary outcome
HbA1c
Time frame: after a two-year trial period
6 secondary outcomes
Adverse events
Body weight
Antibodies
Body composition
Blood glucose
Hypoglycaemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Results publication: PubMed 18387078Bartley 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.
- Results publication: PubMed 19545216Gschwend 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
29 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin detemir, insulin NPH and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 29 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Australia, Argentina, India, South Africa, Bulgaria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: after a two-year trial period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184665, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.