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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01512108
First received: January 10, 2012
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

This trial is conducted in Japan. The aim of this trial is to evaluate the safety of once daily administration of liraglutide in combination with an OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Liraglutide
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: After 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of hypoglycaemic episodes [ Time Frame: After 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in glycosylated haemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]

Enrollment: 363
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lira + OAD Drug: liraglutide

0.9 mg/day liraglutide will be injected once daily subcutaneously (s.c., under the skin) combined with subject's own pre-trial OAD.

Subject's own pre-trial OAD in combination with an additional OAD with a different mechanism of action than the pre-trial OAD. Type and dosage is at the trial physician's discretion within the approval labelling.

  Eligibility

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

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure 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 (diagnosed clinically) for at least 6 months
  • HbA1c (glycosylated haemoglobin A1c) 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 tumour 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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512108

Locations
Japan
Naka-shi, Japan, 311 0113
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Yoshikuni Terada Novo Nordisk Pharma Ltd.
Study Director: Kensuke Kanki Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01512108     History of Changes
Other Study ID Numbers: NN2211-3924, U1111-1121-3457, JapicCTI-121744
Study First Received: January 10, 2012
Last Updated: April 18, 2013
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013