Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes
1 other identifier
interventional
477
9 countries
61
Brief Summary
This trial is conducted in Europe. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes
Started Mar 2003
Shorter than P25 for phase_3 diabetes
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 17, 2008
CompletedFirst Posted
Study publicly available on registry
January 30, 2008
CompletedJanuary 27, 2017
January 1, 2017
10 months
January 17, 2008
January 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
after 26 weeks of treatment
Secondary Outcomes (6)
Fasting plasma glucose
Within-subject variation
Incidence of total hypoglycaemic episodes
Body weight
Incidence of adverse events
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes for at least 12 months since diagnosis
- 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
You may not qualify if:
- Current or previous treatment with thiazolidiones within the last 6 months
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (62)
Novo Nordisk Investigational Site
Arlon, 6700, Belgium
Novo Nordisk Investigational Site
Gilly, 6060, Belgium
Novo Nordisk Investigational Site
Huy, 4500, Belgium
Novo Nordisk Investigational Site
Jumet, 6040, Belgium
Novo Nordisk Investigational Site
Rijeka, 51 000, Croatia
Novo Nordisk Investigational Site
Zagreb, 10 000, Croatia
Novo Nordisk Investigational Site
Århus C, 8000, Denmark
Novo Nordisk Investigational Site
Copenhagen, 2400, Denmark
Novo Nordisk Investigational Site
Hjørring, 9800, Denmark
Novo Nordisk Investigational Site
Hvidovre, 2650, Denmark
Novo Nordisk Investigational Site
Kalundborg, 4400, Denmark
Novo Nordisk Investigational Site
København S, 2300, Denmark
Novo Nordisk Investigational Site
Køge, 4600, Denmark
Novo Nordisk Investigational Site
Slagelse, 4200, Denmark
Novo Nordisk Investigational Site
Amiens, France
Novo Nordisk Investigational Site
Auxerre, 89000, France
Novo Nordisk Investigational Site
Avignon, 84902, France
Novo Nordisk Investigational Site
Dax, 40107, France
Novo Nordisk Investigational Site
Évry, 91014, France
Novo Nordisk Investigational Site
Mougins, 06250, France
Novo Nordisk Investigational Site
Nanterre, 92014, France
Novo Nordisk Investigational Site
Nevers, 58033, France
Novo Nordisk Investigational Site
Rueil-Malmaison, 92501, France
Novo Nordisk Investigational Site
Valenciennes, 59322, France
Novo Nordisk Investigational Site
Vénissieux, 69200, France
Novo Nordisk Investigational Site
Skopje, 1000, North Macedonia
Novo Nordisk Investigational Site
Bekkestua, 1357, Norway
Novo Nordisk Investigational Site
Bergen, NO-5012, Norway
Novo Nordisk Investigational Site
Elverum, 2408, Norway
Novo Nordisk Investigational Site
Gjettum, 1346, Norway
Novo Nordisk Investigational Site
Gjøvik, NO-2819, Norway
Novo Nordisk Investigational Site
Jessheim, 2050, Norway
Novo Nordisk Investigational Site
Oslo, 0370, Norway
Novo Nordisk Investigational Site
Rådal, 5235, Norway
Novo Nordisk Investigational Site
Stavanger, 4011, Norway
Novo Nordisk Investigational Site
Gniewkowo, 88-140, Poland
Novo Nordisk Investigational Site
Krakow, 31-261, Poland
Novo Nordisk Investigational Site
Lodz, 90-030, Poland
Novo Nordisk Investigational Site
Lublin, 20-718, Poland
Novo Nordisk Investigational Site
Rawa Mazowiecka, 96-200, Poland
Novo Nordisk Investigational Site
Szczecin, 71-455, Poland
Novo Nordisk Investigational Site
Tychy, 43-100, Poland
Novo Nordisk Investigational Site
Warsaw, 01-809, Poland
Novo Nordisk Investigational Site
Warsaw, 01-877, Poland
Novo Nordisk Investigational Site
Warsaw, 02-097, Poland
Novo Nordisk Investigational Site
Wołomin, 05-200, Poland
Novo Nordisk Investigational Site
Zabrze, 41-800, Poland
Novo Nordisk Investigational Site
Moscow, 117036, Russia
Novo Nordisk Investigational Site
Moscow, 119435, Russia
Novo Nordisk Investigational Site
Moscow, 123448, Russia
Novo Nordisk Investigational Site
Moscow, 127411, Russia
Novo Nordisk Investigational Site
Saint Petersburg, 194354, Russia
Novo Nordisk Investigational Site
Saint Petersburg, 198013, Russia
Novo Nordisk Investigational Site
Trenčín, 91171, Slovakia
Novo Nordisk Investigational Site
Falun, 791 82, Sweden
Novo Nordisk Investigational Site
Grästorp, 467 22, Sweden
Novo Nordisk Investigational Site
Kristianstad, 291 85, Sweden
Novo Nordisk Investigational Site
Linköping, 581 85, Sweden
Novo Nordisk Investigational Site
Lund, 221 85, Sweden
Novo Nordisk Investigational Site
Lund, 223 70, Sweden
Novo Nordisk Investigational Site
Trelleborg, 231 85, Sweden
Novo Nordisk Investigational Site
Umeå, 901 85, Sweden
Related Publications (3)
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.
PMID: 16732007RESULTDavies 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.
PMID: 18715200RESULTSemlitsch 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.
PMID: 33166419DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2008
First Posted
January 30, 2008
Study Start
March 1, 2003
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
January 27, 2017
Record last verified: 2017-01