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Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00789191
First received: November 10, 2008
Last updated: February 2, 2017
Last verified: February 2017

November 10, 2008
February 2, 2017
November 2008
August 2009   (Final data collection date for primary outcome measure)
HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: Week 26 ]
HbA1c [ Time Frame: After 26 weeks of treatment ]
Complete list of historical versions of study NCT00789191 on ClinicalTrials.gov Archive Site
  • Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% [ Time Frame: Week 26 ]
  • Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia [ Time Frame: Week 26 ]
    Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
  • Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% [ Time Frame: Week 26 ]
  • Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia [ Time Frame: Week 26 ]
    Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
  • Change in BMI (Body Mass Index) [ Time Frame: Week 0, Week 26 ]
  • Change in Body Weight [ Time Frame: Week 0, Week 26 ]
  • FPG (Fasting Plasma Glucose) [ Time Frame: Week 26 ]
  • Hypoglycemic Episodes [ Time Frame: Weeks 0-26 ]
    Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
  • Hypoglycemic Episodes: Day Time [ Time Frame: Weeks 0-26 ]
    Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
  • Hypoglycemic Episodes: Night Time [ Time Frame: Weeks 0-26 ]
    Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
  • Self-measured 9-point Plasma Glucose Profile [ Time Frame: Week 26 ]
  • Proportion of Subjects Achieving HbA1c Less Than or Equal to 7.0% [ Time Frame: After 26 weeks of treatment ]
  • Proportion of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia [ Time Frame: After 26 weeks of treatment ]
  • Proportion of Subjects Achieving HbA1c Less Than or Equal to 6.5% [ Time Frame: After 26 weeks of treatment ]
  • Proportion of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia [ Time Frame: After 26 weeks of treatment ]
  • Change in Body Weight [ Time Frame: After 26 weeks of treatment ]
  • The glycaemic control as measured by FPG (fasting plasma glucose) (assessed by central laboratory) [ Time Frame: After 26 weeks of treatment ]
Not Provided
Not Provided
 
Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes
Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: 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.
  • Drug: sitagliptin
    The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.
  • Drug: metformin
    Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.
  • Drug: 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.
  • Experimental: Comb
    Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
    Interventions:
    • Drug: insulin detemir
    • Drug: sitagliptin
    • Drug: metformin
  • Active Comparator: Sita
    Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
    Interventions:
    • Drug: sitagliptin
    • Drug: metformin
    • Drug: sulphonylurea
Hollander P, Raslova K, Skjøth TV, Råstam 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
August 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Finland,   France,   Hungary,   Korea, Republic of,   Slovakia,   Turkey
 
 
NCT00789191
NN304-3511
2008-001050-40 ( EudraCT Number )
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP