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

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ClinicalTrials.gov Identifier: NCT01572740
Recruitment Status : Completed
First Posted : April 6, 2012
Results First Posted : May 23, 2014
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Drug: insulin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : April 5, 2012
Actual Primary Completion Date : November 1, 2012
Actual Study Completion Date : March 27, 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).



Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572740


Locations
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Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0002
Novo Nordisk Investigational Site
Ebina-shi, Kanagawa, Japan, 243 0401
Novo Nordisk Investigational Site
Ebina-shi, Japan, 243 0432
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, Japan, 582 0005
Novo Nordisk Investigational Site
Katsushika-ku, Tokyo, Japan, 125 0054
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, Japan, 963 8851
Novo Nordisk Investigational Site
Miyazaki-shi, Japan, 880 0034
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, Japan, 311 0113
Novo Nordisk Investigational Site
Niigata-shi, Niigata, Japan, 950 1104
Novo Nordisk Investigational Site
Nishinomiya-shi, Hygo, Japan, 662 0971
Novo Nordisk Investigational Site
Oita-shi, Japan, 870 0039
Novo Nordisk Investigational Site
Okawa-shi, Fukuoka, Japan, 831 0016
Novo Nordisk Investigational Site
Osaka-shi, Osaka, Japan, 553 0003
Novo Nordisk Investigational Site
Ota-ku, Tokyo, Japan, 144 0035
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, Japan, 323 0022
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, Japan, 060 0062
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, Japan, 062 0007
Novo Nordisk Investigational Site
Sendai-shi, Japan, 980 0021
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, Japan, 329 0433
Novo Nordisk Investigational Site
Shizuoka-shi, Japan, 424 0853
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, Japan, 569 1096
Novo Nordisk Investigational Site
Tokyo, Japan, 187 8510
Novo Nordisk Investigational Site
Yokohama-shi, Japan, 235 0045
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01572740    
Other Study ID Numbers: NN2211-3925
U1111-1122-4320 ( Other Identifier: WHO )
JapicCTI-121802 ( Other Identifier: JAPIC )
First Posted: April 6, 2012    Key Record Dates
Results First Posted: May 23, 2014
Last Update Posted: February 7, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists