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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789191
First Posted: November 11, 2008
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • 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 ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789191


  Show 51 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00789191     History of Changes
Other Study ID Numbers: NN304-3511
2008-001050-40 ( EudraCT Number )
First Submitted: November 10, 2008
First Posted: November 11, 2008
Results First Submitted: November 18, 2010
Results First Posted: December 10, 2010
Last Update Posted: March 14, 2017
Last Verified: February 2017

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