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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01572740
First received: April 4, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: placebo
Drug: insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16 [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.


Secondary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36 [ Time Frame: Week 0, Week 36 ] [ Designated as safety issue: No ]
    Estimated mean change from baseline in HbA1c after 36 Weeks of treatment

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16 [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    Estimated mean change from baseline in FPG after 16 Weeks of treatment.

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36 [ Time Frame: Week 0, Week 36 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    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 Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36 [ Time Frame: Week 0, Week 36 ] [ Designated as safety issue: No ]
    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.

  • Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16 [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 0, Week 36 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    Estimated mean change in body weight after 16 Weeks of treatment

  • Change in Body Weight From Baseline to Week 36 [ Time Frame: Week 0, Week 36 ] [ Designated as safety issue: No ]
    Estimated mean change in body weight after 36 Weeks of treatment

  • Number of Adverse Events (AEs) [ Time Frame: Week 0 to Week 36 (inclusive) ] [ Designated as safety issue: No ]
    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.

  • Number of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to week 36 (inclusive) ] [ Designated as safety issue: No ]

    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).



Enrollment: 257
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lira+Insulin Drug: liraglutide
Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
Drug: insulin
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.
Placebo Comparator: Placebo+Insulin Drug: placebo
Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
Drug: insulin
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572740

Locations
Japan
Chuo-ku, Tokyo, Japan, 103 0002
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01572740     History of Changes
Other Study ID Numbers: NN2211-3925, U1111-1122-4320, JapicCTI-121802
Study First Received: April 4, 2012
Results First Received: March 27, 2014
Last Updated: June 11, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Liraglutide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014