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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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00789191
First received: November 10, 2008
Last updated: June 26, 2012
Last verified: June 2012

November 10, 2008
June 26, 2012
November 2008
August 2009   (final data collection date for primary outcome measure)
HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
  • Change in BMI (Body Mass Index) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Change in Body Weight [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • FPG (Fasting Plasma Glucose) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Hypoglycemic Episodes [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving HbA1c less than or equal to 7.0% [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving HbA1C less than or equal to 7.0% without symptomatic hypoglycaemia [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving HbA1c less than or equal to 6.5% [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving HbA1c less than or equal to 6.5% without symptomatic hypoglycaemia [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • The glycaemic control as measured by FPG (fasting plasma glucose) (assessed by central laboratory) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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
Not Provided

*   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
Both
18 Years and older
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
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Tine Møller Jørgensen, M.Sc. Pharm Novo Nordisk A/S
Novo Nordisk A/S
June 2012

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