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Completed

NCT Number: NCT01572740

Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.

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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

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Chuo-ku, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day
  • Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)
  • Body Mass Index (BMI) below 45.0 kg/m^2

Exclusion criteria

  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Known proliferative retinopathy or maculopathy requiring treatment according to the investigator
  • Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening
  • Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening

Treatment and study plan

liraglutide

Drug

Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.

Placebo

Drug

Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.

Insulin

Drug

All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16

    Time frame: Week 0, Week 16

    Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.

Secondary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36

    Time frame: Week 0, Week 36

    Estimated mean change from baseline in HbA1c after 36 Weeks of treatment

  2. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16

    Time frame: Week 0, Week 16

    Estimated mean change from baseline in FPG after 16 Weeks of treatment.

  3. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36

    Time frame: Week 0, Week 36

    Estimated mean change from baseline in FPG after 36 Weeks of treatment.

  4. Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16

    Time frame: Week 0, Week 16

    Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.

  5. Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36

    Time frame: Week 0, Week 36

    Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.

  6. Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16

    Time frame: Week 0, Week 16

    Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.

  7. Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36

    Time frame: Week 0, Week 36

    Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.

  8. Change in Body Weight From Baseline to Week 16

    Time frame: Week 0, Week 16

    Estimated mean change in body weight after 16 Weeks of treatment

  9. Change in Body Weight From Baseline to Week 36

    Time frame: Week 0, Week 36

    Estimated mean change in body weight after 36 Weeks of treatment

  10. Number of Adverse Events (AEs)

    Time frame: Week 0 to Week 36 (inclusive)

    An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.

  11. Number of Confirmed Hypoglycaemic Episodes

    Time frame: Week 0 to week 36 (inclusive)

    A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes.

    Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG < 3.1 mmol/L (56 mg/dL). Minor: PG < 3.1 mmol/L (56 mg/dL).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 36-week, Randomised, Multi-centre, Double-blind, Parallel Group Trial to Investigate the Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 6, 2012
Registry last updated
Feb 7, 2018

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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