Clinical trial NCT00789191: Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes
Official title: Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 6 months before trial start
* 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:

* Known or suspected allergy or intolerance to any of the trial products or related products
* 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

Primary outcomes:
measure: HbA1c (Glycosylated Haemoglobin A1c)
timeFrame: Week 26
Secondary outcomes:
measure: Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
timeFrame: Week 26
measure: Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
timeFrame: Week 26
measure: Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
timeFrame: Week 26
measure: Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
timeFrame: Week 26
measure: Change in BMI (Body Mass Index)
timeFrame: Week 0, Week 26
measure: Change in Body Weight
timeFrame: Week 0, Week 26
measure: FPG (Fasting Plasma Glucose)
timeFrame: Week 26
measure: Hypoglycemic Episodes
timeFrame: Weeks 0-26
measure: Hypoglycemic Episodes: Day Time
timeFrame: Weeks 0-26
measure: Hypoglycemic Episodes: Night Time
timeFrame: Weeks 0-26
measure: Self-measured 9-point Plasma Glucose Profile
timeFrame: Week 26
Other outcomes:
Locations:
city: Vestavia
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Orange
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Santa Monica
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Dunwoody
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: West Seneca
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Norristown
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Coquitlam
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: New Westminster
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: St. John's
country: Canada
facility: Novo Nordisk Investigational Site
state: Newfoundland and Labrador
city: Cambridge
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Sherbrooke
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: St. Romuald
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Niagara Falls
country: Canada
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Loimaa
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Pieksämäki
country: Finland
facility: Novo Nordisk Investigational Site
city: Pori
country: Finland
facility: Novo Nordisk Investigational Site
city: Seinäjoki
country: Finland
facility: Novo Nordisk Investigational Site
city: Brest
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHE-sur-YON cedex 9
country: France
facility: Novo Nordisk Investigational Site
city: Le Creusot
country: France
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: Montigny-les-Metz
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: Roubaix
country: France
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Eger
country: Hungary
facility: Novo Nordisk Investigational Site
city: Pécs
country: Hungary
facility: Novo Nordisk Investigational Site
city: Daegu
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Incheon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Lucenec
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Presov
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Zilina
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Kocaeli
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.