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Completed

NCT Number: NCT00789191

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Coquitlam, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

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.

Sitagliptin

Drug

The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.

metformin

Drug

Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.

Sulphonylurea

Drug

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.

Primary outcomes

  1. HbA1c (Glycosylated Haemoglobin A1c)

    Time frame: Week 26

Secondary outcomes

  1. Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%

    Time frame: Week 26

  2. 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

  3. Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%

    Time frame: Week 26

  4. 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

  5. Change in BMI (Body Mass Index)

    Time frame: Week 0, Week 26

  6. Change in Body Weight

    Time frame: Week 0, Week 26

  7. FPG (Fasting Plasma Glucose)

    Time frame: Week 26

  8. 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

  9. 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

  10. 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

  11. Self-measured 9-point Plasma Glucose Profile

    Time frame: Week 26

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2008
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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