Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01572740
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo+Insulin insulin - Lira+Insulin insulin - Placebo+Insulin placebo - Lira+Insulin liraglutide -
- Primary Outcome Measures
Name Time Method Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16 Week 0, Week 16 Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.
- Secondary Outcome Measures
Name Time Method Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36 Week 0, Week 36 Estimated mean change from baseline in HbA1c after 36 Weeks of treatment
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16 Week 0, Week 16 Estimated mean change from baseline in FPG after 16 Weeks of treatment.
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36 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.
Number of Adverse Events (AEs) 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.
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36 Week 0, Week 36 Estimated mean change from baseline in FPG after 36 Weeks of treatment.
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16 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.
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16 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.
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36 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.
Change in Body Weight From Baseline to Week 16 Week 0, Week 16 Estimated mean change in body weight after 16 Weeks of treatment
Change in Body Weight From Baseline to Week 36 Week 0, Week 36 Estimated mean change in body weight after 36 Weeks of treatment
Number of Confirmed Hypoglycaemic Episodes 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).
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Yokohama-shi, Japan