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Completed

NCT Number: NCT00856986

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.

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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–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Bonheiden, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator
  • HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
  • HbA1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea

Exclusion criteria

  • Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator)
  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening
  • Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
  • Impaired kidney function
  • Impaired liver function
  • Uncontrolled treated/untreated hypertension
  • Cancer or any clinically significant disease or disorder as judged by the Investigator
  • Previous participation in the run-in phase of this trial. Re-screening is allowed once
  • History of chronic pancreatitis or idiopathic pancreatitis

Treatment and study plan

liraglutide

Drug

Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.

insulin detemir

Drug

Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm

metformin

Drug

Metformin tablets, at least 1500 mg/day

Primary outcomes

  1. Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.

    Time frame: Week 0 (Randomisation), week 26

Secondary outcomes

  1. Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)

    Time frame: Week 0, Week 52

  2. Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)

    Time frame: Week 0, Week 52

  3. Mean Change From Randomisation in Fasting Plasma Glucose at Week 26

    Time frame: Week 0 (Randomisation), Week 26

  4. Mean Change From Randomisation in Fasting Plasma Glucose at Week 52

    Time frame: Week 0, Week 52

  5. Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26

    Time frame: Week 0 (Randomisation), Week 26

    Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.

  6. Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52

    Time frame: Week 0, Week 52

    Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.

  7. Mean Change From Randomisation in Fasting Insulin at Week 26

    Time frame: Week 0 (Randomisation), Week 26

  8. Mean Change From Randomisation in Fasting Insulin at Week 52

    Time frame: Week 0 (Randomisation), Week 52

  9. Mean Change From Randomisation in Fasting Pro-insulin at Week 26.

    Time frame: Week 0 (Randomisation), Week 26

  10. Mean Change From Randomisation in Fasting Pro-insulin at Week 52

    Time frame: Week 0, Week 52

  11. Mean Change From Randomisation in Fasting C-peptide at Week 26.

    Time frame: Week 0 (Randomisation), Week 26

  12. Mean Change From Randomisation in Fasting C-peptide at Week 52.

    Time frame: Week 0, Week 52

  13. Mean Changes From Randomisation in Cholesterol Lipids at Week 26.

    Time frame: Week 0 (Randomisation), Week 26

    Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)

  14. Mean Changes From Randomisation in Cholesterol Lipids at Week 52.

    Time frame: Week 0, Week 52

    Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)

  15. Mean Change From Randomisation in Lipids: Triglycerides at Week 26

    Time frame: Week 0 (Randomisation), Week 26

  16. Mean Change From Randomisation in Lipids: Triglycerides at Week 52

    Time frame: Week 0, Week 52

  17. Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26

    Time frame: Week 0 (Randomisation), Week 26

  18. Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52

    Time frame: Week 0, Week 52

  19. Mean Change From Randomisation in Body Weight at Week 26

    Time frame: Week 0 (Randomisation), Week 26

  20. Mean Change From Randomisation in Body Weight at Week 52

    Time frame: Week 0, Week 52

  21. Mean Change From Randomisation in Waist Circumference at Week 26.

    Time frame: Week 0 (Randomisation), Week 26

  22. Mean Change From Randomisation in Waist Circumference at Week 52.

    Time frame: Week 0, Week 52

  23. Mean Change From Randomisation in Hip Circumference at Week 26

    Time frame: Week 0 (Randomisation), Week 26

  24. Mean Change From Randomisation in Hip Circumference at Week 52

    Time frame: Week 0, week 52

  25. Mean Change From Randomisation in Waist to Hip Ratio at Week 26

    Time frame: Week 0 (Randomisation), Week 26

    Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference

  26. Mean Change From Randomisation in Waist to Hip Ratio at Week 52

    Time frame: Week 0, Week 52

    Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference

  27. Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.

    Time frame: Week 0 (Randomisation), Week 26

  28. Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.

    Time frame: Week 0, Week 52

  29. Adverse Events From Run-in (Week -12) to Week 52

    Time frame: Run-in (week -12) to Week 52

  30. Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

    Time frame: weeks 0-26

    Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  31. Hypoglycaemic Episodes Weeks 0-52

    Time frame: Week 0-52

    Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extension

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 6, 2009
Registry last updated
Mar 8, 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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