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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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
liraglutide
placebo
insulin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lira+Insulin

Placebo+Insulin

Arm Description

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
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
Estimated mean change from baseline in HbA1c after 36 Weeks of treatment
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
Estimated mean change from baseline in FPG after 16 Weeks of treatment.
Change in Fasting Plasma Glucose (FPG) From Baseline to 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
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
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
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
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
Estimated mean change in body weight after 16 Weeks of treatment
Change in Body Weight From Baseline to Week 36
Estimated mean change in body weight after 36 Weeks of treatment
Number of Adverse Events (AEs)
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
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).

Full Information

First Posted
April 4, 2012
Last Updated
January 11, 2018
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01572740
Brief Title
Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 5, 2012 (Actual)
Primary Completion Date
November 1, 2012 (Actual)
Study Completion Date
March 27, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lira+Insulin
Arm Type
Experimental
Arm Title
Placebo+Insulin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
Intervention Type
Drug
Intervention Name(s)
insulin
Intervention Description
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 Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
Description
Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.
Time Frame
Week 0, Week 16
Secondary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36
Description
Estimated mean change from baseline in HbA1c after 36 Weeks of treatment
Time Frame
Week 0, Week 36
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
Description
Estimated mean change from baseline in FPG after 16 Weeks of treatment.
Time Frame
Week 0, Week 16
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36
Description
Estimated mean change from baseline in FPG after 36 Weeks of treatment.
Time Frame
Week 0, Week 36
Title
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16
Description
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.
Time Frame
Week 0, Week 16
Title
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36
Description
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.
Time Frame
Week 0, Week 36
Title
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16
Description
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.
Time Frame
Week 0, Week 16
Title
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36
Description
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.
Time Frame
Week 0, Week 36
Title
Change in Body Weight From Baseline to Week 16
Description
Estimated mean change in body weight after 16 Weeks of treatment
Time Frame
Week 0, Week 16
Title
Change in Body Weight From Baseline to Week 36
Description
Estimated mean change in body weight after 36 Weeks of treatment
Time Frame
Week 0, Week 36
Title
Number of Adverse Events (AEs)
Description
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.
Time Frame
Week 0 to Week 36 (inclusive)
Title
Number of Confirmed Hypoglycaemic Episodes
Description
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).
Time Frame
Week 0 to week 36 (inclusive)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
103 0002
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ebina-shi, Kanagawa
ZIP/Postal Code
243 0401
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ebina-shi
ZIP/Postal Code
243 0432
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kashiwara-shi, Osaka
ZIP/Postal Code
582 0005
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Katsushika-ku, Tokyo
ZIP/Postal Code
125 0054
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Koriyama-shi, Fukushima
ZIP/Postal Code
963 8851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Miyazaki-shi
ZIP/Postal Code
880 0034
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Naka-shi, Ibaraki
ZIP/Postal Code
311 0113
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Niigata-shi, Niigata
ZIP/Postal Code
950 1104
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Nishinomiya-shi, Hygo
ZIP/Postal Code
662 0971
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Oita-shi
ZIP/Postal Code
870 0039
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Okawa-shi, Fukuoka
ZIP/Postal Code
831 0016
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka-shi, Osaka
ZIP/Postal Code
553 0003
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ota-ku, Tokyo
ZIP/Postal Code
144 0035
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Oyama-shi, Tochigi
ZIP/Postal Code
323 0022
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060 0062
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
062 0007
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sendai-shi
ZIP/Postal Code
980 0021
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shimotsuke-shi, Tochigi
ZIP/Postal Code
329 0433
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shizuoka-shi
ZIP/Postal Code
424 0853
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Takatsuki-shi, Osaka
ZIP/Postal Code
569 1096
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
187 8510
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Yokohama-shi
ZIP/Postal Code
235 0045
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27182042
Citation
Seino Y, Kaneko S, Fukuda S, Osonoi T, Shiraiwa T, Nishijima K, Bosch-Traberg H, Kaku K. Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36-week, randomized, double-blind, parallel-group trial. J Diabetes Investig. 2016 Jul;7(4):565-73. doi: 10.1111/jdi.12457. Epub 2016 Jan 23.
Results Reference
result
PubMed Identifier
29277968
Citation
Kaneko S, Nishijima K, Bosch-Traberg H, Kaku K, Seino Y. Efficacy and safety of adding liraglutide to existing insulin regimens in Japanese patients with type 2 diabetes mellitus: A post-hoc analysis of a phase 3 randomized clinical trial. J Diabetes Investig. 2018 Jul;9(4):840-849. doi: 10.1111/jdi.12793. Epub 2018 Feb 5.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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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