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
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: sitagliptin
Drug: metformin
Drug: sulphonylurea
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 222
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comb
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
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.
Active Comparator: Sita
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789191

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Orange, California, United States, 92869
Novo Nordisk Clinical Trial Call Center
Santa Monica, California, United States, 90404
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Dunwoody, Georgia, United States, 30338
Novo Nordisk Clinical Trial Call Center
Vestavia, Georgia, United States, 35209
United States, New York
Novo Nordisk Clinical Trial Call Center
West Seneca, New York, United States, 14224
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45245
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45439
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Norristown, Pennsylvania, United States, 19401
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37411
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Canada, British Columbia
Coquitlam, British Columbia, Canada, V3K 3P4
Finland
Pieksämäki, Finland, 76100
France
Narbonne, France, 11108
Hungary
Budapest, Hungary, H-1212
Korea, Republic of
Incheon, Korea, Republic of, 400-103
Slovakia
Bratislava, Slovakia, 831 01
Turkey
Izmit, Turkey, 41380
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tine Møller Jørgensen, M.Sc. Pharm Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00789191     History of Changes
Other Study ID Numbers: NN304-3511, 2008-001050-40
Study First Received: November 10, 2008
Results First Received: November 18, 2010
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration
Canada: The Biologics and Genetic Therapies Directorate (BGTD)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014