A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S1 site in 1 country819 target enrollmentNovember 18, 2015

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec/liraglutide insulin degludec liraglutide

Drugsinsulin degludec/liraglutide insulin degludec liraglutide

Overview

Phase: Phase 3
Intervention: insulin degludec/liraglutide
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 819
Locations: 1
Primary Endpoint: Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.

Registry

clinicaltrials.gov

Start Date

November 18, 2015

End Date

December 22, 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female Japanese subjects, age at least 20 years at the time of signing informed consent
•Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
•HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
•Body-mass index (BMI) above or equal to 20 kg/m\^2
•Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling

Exclusion Criteria

•Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)
•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
•Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism
•Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal
•Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
•Screening calcitonin equal to or above 50 ng/L
•History of pancreatitis (acute or chronic)
•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
•Subjects presently classified as being in New York Heart Association (NYHA) Class IV

Arms & Interventions

Insulin degludec/liraglutide OD

Intervention: insulin degludec/liraglutide

Insulin degludec OD

Intervention: insulin degludec

Liraglutide OD

Intervention: liraglutide

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira

Time Frame: Week 0, Week 52

Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira).

Secondary Outcomes

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes(Weeks 0-52)
Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg(Week 0, Week 52)
Insulin Dose(After 52 weeks of treatment)
Change From Baseline in Body Weight (kg)(Week 0, Week 52)
Responder (Yes/no): HbA1c Less Than 7.0%(After 52 weeks of treatment)
Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment(After 52 weeks of treatment)
Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero(After 52 weeks of treatment)
Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment(After 52 weeks of treatment)
Fasting C-peptide as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
Proinsulin as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, Week 52)
Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero(After 52 weeks of treatment)
Responder (Yes/no): HbA1c Less Than 6.5%(After 52 weeks of treatment)
Change in Waist Circumference(Week 0, Week 52)
Change in SMBG 9-point Profile - Mean of the 9-point Profile(Week 0, week 52)
Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
Triglycerides as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes(0-52 weeks)
Anti-drug Antibodies: Anti-insulin Degludec Antibodies(at week 52)
Change in Clinical Evaluation: Pulse(Week 0, week 52)
Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.(After 52 weeks of treatment)
Change in Blood Pressure (Systolic and Diastolic)(Week 0, Week 52)
Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)(Week 0, week 52)
Free Fatty Acids as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
Change in Clinical Evaluation: Fundoscopy or Fundus Photography(at screening (week -2 to week 0), at week 52)
Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.(After 52 weeks of treatment)
Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)(After 52 weeks of the treatment)
Total Cholesterol as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
Fasting Human Insulin as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
Fasting Glucagon as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(0-52 weeks)
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition(0-52 weeks)
Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies(at week 52)
Change in Clinical Evaluation: Electrocardiogram (ECG)(at screening (week -2 to week 0), at week 52)
Serum Concentrations of Insulin Degludec(Weeks 2, 8, 16, 26, 44, 52)
Plasma Concentrations of Liraglutide(Weeks 2, 8, 16, 26, 44, 52)
Number of Treatment Emergent Adverse Events (TEAEs)(0-52 weeks)