Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes
NCT ID: NCT00604396
Last Updated: 2017-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
477 participants
INTERVENTIONAL
2003-03-31
2004-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Study Describing Conditions for Administering Slow-acting Insulin Analogue With Oral Antidiabetic Agents in Type 2 Diabetes on Blood Glucose Control
NCT00700960
Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes
NCT00104182
Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes
NCT00506662
Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
NCT01497561
Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes
NCT00283751
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
insulin detemir
insulin NPH
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Insulin naive subjects
* OAD treatment for at least 4 months alone or combined with no more than two OADs
* Body mass index (BMI) below 35.0 kg/m2
* HbA1c between 7.5-10.0%
* Able and willing to use twice a day injections for the entire trial period
Exclusion Criteria
* OAD treatment with three or more OADs within the last 6 months
* Acute insulin treatment for longer than 7 days in a row within the last 6 months
* Secondary diabetes
* Known maturity onset of diabetes of young (MODY)
* Known or suspected allergy to trial product or related products
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Arlon, , Belgium
Novo Nordisk Investigational Site
Gilly, , Belgium
Novo Nordisk Investigational Site
Huy, , Belgium
Novo Nordisk Investigational Site
Jumet, , Belgium
Novo Nordisk Investigational Site
Rijeka, , Croatia
Novo Nordisk Investigational Site
Zagreb, , Croatia
Novo Nordisk Investigational Site
Århus C, , Denmark
Novo Nordisk Investigational Site
Copenhagen, , Denmark
Novo Nordisk Investigational Site
Hjørring, , Denmark
Novo Nordisk Investigational Site
Hvidovre, , Denmark
Novo Nordisk Investigational Site
Kalundborg, , Denmark
Novo Nordisk Investigational Site
København S, , Denmark
Novo Nordisk Investigational Site
Køge, , Denmark
Novo Nordisk Investigational Site
Slagelse, , Denmark
Novo Nordisk Investigational Site
Amiens, , France
Novo Nordisk Investigational Site
Auxerre, , France
Novo Nordisk Investigational Site
Avignon, , France
Novo Nordisk Investigational Site
Dax, , France
Novo Nordisk Investigational Site
Évry, , France
Novo Nordisk Investigational Site
Mougins, , France
Novo Nordisk Investigational Site
Nanterre, , France
Novo Nordisk Investigational Site
Nevers, , France
Novo Nordisk Investigational Site
Rueil-Malmaison, , France
Novo Nordisk Investigational Site
Valenciennes, , France
Novo Nordisk Investigational Site
Vénissieux, , France
Novo Nordisk Investigational Site
Skopje, , North Macedonia
Novo Nordisk Investigational Site
Bekkestua, , Norway
Novo Nordisk Investigational Site
Bergen, , Norway
Novo Nordisk Investigational Site
Elverum, , Norway
Novo Nordisk Investigational Site
Gjettum, , Norway
Novo Nordisk Investigational Site
Gjøvik, , Norway
Novo Nordisk Investigational Site
Jessheim, , Norway
Novo Nordisk Investigational Site
Oslo, , Norway
Novo Nordisk Investigational Site
Rådal, , Norway
Novo Nordisk Investigational Site
Stavanger, , Norway
Novo Nordisk Investigational Site
Gniewkowo, , Poland
Novo Nordisk Investigational Site
Krakow, , Poland
Novo Nordisk Investigational Site
Lodz, , Poland
Novo Nordisk Investigational Site
Lublin, , Poland
Novo Nordisk Investigational Site
Rawa Mazowiecka, , Poland
Novo Nordisk Investigational Site
Szczecin, , Poland
Novo Nordisk Investigational Site
Tychy, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Wołomin, , Poland
Novo Nordisk Investigational Site
Zabrze, , Poland
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Trenčín, , Slovakia
Novo Nordisk Investigational Site
Falun, , Sweden
Novo Nordisk Investigational Site
Grästorp, , Sweden
Novo Nordisk Investigational Site
Kristianstad, , Sweden
Novo Nordisk Investigational Site
Linköping, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Trelleborg, , Sweden
Novo Nordisk Investigational Site
Umeå, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006 Jun;29(6):1269-74. doi: 10.2337/dc05-1365.
Davies MJ, Derezinski T, Pedersen CB, Clauson P. Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia. Diabetes Technol Ther. 2008 Aug;10(4):273-7. doi: 10.1089/dia.2008.0282.
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NN304-1530
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.