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Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
liraglutide
oral anti-diabetic drug
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:

  • Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)
  • Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1
  • Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
  • HbA1c between 7.0-10.0% (both inclusive)
  • Body Mass Index (BMI) below 40.0 kg/m^2
  • Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed
  • Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)

Exclusion Criteria:

  • Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
  • Calcitonin above or equal to 160 pg/mL
  • Personal history of non-familial medullary thyroid carcinoma
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1
  • Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)

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
  • 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

Active Comparator

Arm Label

Liraglutide + an OAD therapy

Two OADs combination therapy

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events (AEs)
Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.

Secondary Outcome Measures

Number of Confirmed Hypoglycaemic Episodes
Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).
Change in HbA1c From Baseline to Week 52
Estimated mean change in HbA1c from baseline after 52 Weeks of treatment
Change in FPG From Baseline to Week 52
Estimated mean change from baseline in FPG after 52 Weeks of treatment

Full Information

First Posted
January 10, 2012
Last Updated
November 8, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01512108
Brief Title
Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
Official Title
A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 10, 2012 (Actual)
Primary Completion Date
April 26, 2013 (Actual)
Study Completion Date
April 26, 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 was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.

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
None (Open Label)
Allocation
Randomized
Enrollment
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide + an OAD therapy
Arm Type
Experimental
Arm Title
Two OADs combination therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
oral anti-diabetic drug
Intervention Description
An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (AEs)
Description
Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.
Time Frame
Week 0 to Week 52 + 7 days
Secondary Outcome Measure Information:
Title
Number of Confirmed Hypoglycaemic Episodes
Description
Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).
Time Frame
Week 0 to Week 52
Title
Change in HbA1c From Baseline to Week 52
Description
Estimated mean change in HbA1c from baseline after 52 Weeks of treatment
Time Frame
Week 0, week 52
Title
Change in FPG From Baseline to Week 52
Description
Estimated mean change from baseline in FPG after 52 Weeks of treatment
Time Frame
Week 0, week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.) Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1 Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months HbA1c between 7.0-10.0% (both inclusive) Body Mass Index (BMI) below 40.0 kg/m^2 Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed Subjects able and willing to perform self-monitoring of plasma glucose (SMPG) Exclusion Criteria: Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer) Calcitonin above or equal to 160 pg/mL Personal history of non-familial medullary thyroid carcinoma Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC) History of chronic pancreatitis or idiopathic acute pancreatitis Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1 Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)
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
Chuo-ku, Tokyo
ZIP/Postal Code
103 0027
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ehime, Japan
ZIP/Postal Code
790 0067
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka, Japan
ZIP/Postal Code
810 8798
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
815 8555
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka
ZIP/Postal Code
812 0025
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka
ZIP/Postal Code
818 8502
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka
ZIP/Postal Code
820 8505
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kamagaya-shi, Chiba
ZIP/Postal Code
273 0121
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
Kawagoe-shi, Saitama
ZIP/Postal Code
350 0851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kitakyushu-shi, Fukuoka
ZIP/Postal Code
800 0252
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
Kumamoto-shi,Kumamoto
ZIP/Postal Code
862 0976
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kurume-shi, Fukuoka
ZIP/Postal Code
839 0863
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
Oita
ZIP/Postal Code
870 8511
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
532 0003
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka-shi, Osaka
ZIP/Postal Code
545 8586
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
060-0001
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
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
Tagajo-shi
ZIP/Postal Code
985 0852
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
Tochigi
ZIP/Postal Code
329 0498
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
104 0044
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
113 0031
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
125 0054
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Yamaguchi
ZIP/Postal Code
755 0067
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
26816604
Citation
Kaku K, Kiyosue A, Ono Y, Shiraiwa T, Kaneko S, Nishijima K, Bosch-Traberg H, Seino Y. Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial. J Diabetes Investig. 2016 Jan;7(1):76-84. doi: 10.1111/jdi.12367. Epub 2015 Jul 14. Erratum In: J Diabetes Investig. 2016 Mar;7(2):279.
Results Reference
result
PubMed Identifier
28984041
Citation
Kiyosue A, Seino Y, Nishijima K, Bosch-Traberg H, Kaku K. Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial. J Diabetes Investig. 2018 Jul;9(4):831-839. doi: 10.1111/jdi.12759. Epub 2017 Nov 24.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

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