Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes
NCT ID: NCT00789191
Last Updated: 2017-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
222 participants
INTERVENTIONAL
2008-11-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Comb
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
insulin detemir
The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial.
sitagliptin
The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.
metformin
Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.
Sita
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
sitagliptin
The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.
metformin
Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.
sulphonylurea
Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator.
Interventions
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insulin detemir
The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial.
sitagliptin
The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.
metformin
Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.
sulphonylurea
Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator.
Eligibility Criteria
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Inclusion Criteria
* Treatment with at least 1000 mg metformin per day for at least 3 months
* Insulin-naive (short-term insulin treatment of up to 14 days is allowed)
* DPP-4 (dipeptidyl peptidase-4) inhibitor naive
* HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis
* BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2
* Able and willing to take one subcutaneous injection every day
* Able and willing to perform mandatory SMPG (self measured plasma glucose) measurements
Exclusion Criteria
* Severe hypertension
* Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
* Cardiac disease, within the last 12 months
* Impaired hepatic function
* Impaired renal function
* Proliferative retinopathy or macular oedema requiring acute treatment
* Female of childbearing potential
* Known or suspected abuse of alcohol, narcotics or illicit substances
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Le Creusot, , France
Novo Nordisk Investigational Site
Lille, , France
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Eger, , Hungary
Novo Nordisk Investigational Site
Pécs, , Hungary
Novo Nordisk Investigational Site
Bratislava, , Slovakia
Novo Nordisk Investigational Site
Bratislava, , Slovakia
Novo Nordisk Investigational Site
Košice, , Slovakia
Novo Nordisk Investigational Site
Lučenec, , Slovakia
Novo Nordisk Investigational Site
Prešov, , Slovakia
Novo Nordisk Investigational Site
Žilina, , Slovakia
Novo Nordisk Investigational Site
Daegu, , South Korea
Novo Nordisk Investigational Site
Incheon, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Montigny-lès-Metz, , France
Novo Nordisk Investigational Site
Narbonne, , France
Novo Nordisk Investigational Site
Roubaix, , France
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, United States
Novo Nordisk Investigational Site
Orange, California, United States
Novo Nordisk Investigational Site
Santa Monica, California, United States
Novo Nordisk Investigational Site
Dunwoody, Georgia, United States
Novo Nordisk Investigational Site
West Seneca, New York, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Dayton, Ohio, United States
Novo Nordisk Investigational Site
Norristown, Pennsylvania, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Coquitlam, British Columbia, Canada
Novo Nordisk Investigational Site
New Westminster, British Columbia, Canada
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, Canada
Novo Nordisk Investigational Site
Cambridge, Ontario, Canada
Novo Nordisk Investigational Site
Niagara Falls, Ontario, Canada
Novo Nordisk Investigational Site
Toronto, Ontario, Canada
Novo Nordisk Investigational Site
Toronto, Ontario, Canada
Novo Nordisk Investigational Site
Saint Romuald, Quebec, Canada
Novo Nordisk Investigational Site
Sherbrooke, Quebec, Canada
Novo Nordisk Investigational Site
Niagara Falls, , Canada
Novo Nordisk Investigational Site
Helsinki, , Finland
Novo Nordisk Investigational Site
Loimaa, , Finland
Novo Nordisk Investigational Site
Oulu, , Finland
Novo Nordisk Investigational Site
Pieksämäki, , Finland
Novo Nordisk Investigational Site
Pori, , Finland
Novo Nordisk Investigational Site
Seinäjoki, , Finland
Novo Nordisk Investigational Site
Brest, , France
Novo Nordisk Investigational Site
La Roche-sur-Yon, , France
Novo Nordisk Investigational Site
Ankara, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Kocaeli, , Turkey (Türkiye)
Countries
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References
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Hollander P, Raslova K, Skjoth TV, Rastam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-001050-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN304-3511
Identifier Type: -
Identifier Source: org_study_id
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