Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01572740
NCT01572740CompletedPhase 3

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

Novo Nordisk A/S1 site in 1 country257 target enrollmentStarted: April 5, 2012Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
257
Locations
1
Primary Endpoint
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Lira+Insulin

Experimental

Intervention: liraglutide (Drug)

Lira+Insulin

Experimental

Intervention: insulin (Drug)

Placebo+Insulin

Placebo Comparator

Intervention: placebo (Drug)

Placebo+Insulin

Placebo Comparator

Intervention: insulin (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16(Week 0, Week 16)
  • Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36(Week 0, Week 36)
  • Number of Adverse Events (AEs)(Week 0 to Week 36 (inclusive))
  • Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36(Week 0, Week 36)
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36(Week 0, Week 36)
  • Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16(Week 0, Week 16)
  • Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16(Week 0, Week 16)
  • Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36(Week 0, Week 36)
  • Change in Body Weight From Baseline to Week 16(Week 0, Week 16)
  • Change in Body Weight From Baseline to Week 36(Week 0, Week 36)
  • Number of Confirmed Hypoglycaemic Episodes(Week 0 to week 36 (inclusive))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 3
Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan SyndromeGenetic DisorderNoonan Syndrome
NCT01927861Novo Nordisk A/S51
Completed
Phase 2
Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic FeverAcquired Bleeding DisorderDengue Haemorrhagic Fever
NCT01601613Novo Nordisk A/S28
Completed
Phase 4
Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2
NCT01892020Novo Nordisk A/S161
Completed
Phase 3
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short StatureGrowth DisorderIdiopathic Short Stature
NCT01778023Novo Nordisk A/S54
Completed
Phase 1
Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese SubjectsHealthyDiabetes
NCT01868555Novo Nordisk A/S32