A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

Novo Nordisk A/S1 site in 1 country1,663 target enrollmentMay 23, 2011

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec insulin degludec/liraglutide liraglutide

Drugsinsulin degludec/liraglutide insulin degludec liraglutide

Overview

Phase: Phase 3
Intervention: insulin degludec
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 1663
Locations: 1
Primary Endpoint: Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.

Registry

clinicaltrials.gov

Start Date

May 23, 2011

End Date

November 22, 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects with type 2 diabetes
•HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
•Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)
•Subjects on stable dose of 1-2 OADs (metformin \[at least 1500 mg or max tolerated dose\] or metformin \[at least 1500 mg or max tolerated dose\] + pioglitazone \[at least 30 mg\]) for at least 90 days prior to screening
•Body Mass Index (BMI) maximum 40 kg/m\^2

Exclusion Criteria

•Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)
•Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial
•Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
•Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
•Screening calcitonin at least 50 ng/L
•Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
•Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
•Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)
•Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
•History of chronic pancreatitis or idiopathic acute pancreatitis

Arms & Interventions

IDeg

Intervention: insulin degludec

IDegLira

Intervention: insulin degludec/liraglutide

Lira

Intervention: liraglutide

Outcomes

Primary Outcomes

Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.

Time Frame: Week 0, week 26

Values of mean change in HbA1c.

Secondary Outcomes

Mean Change From Baseline in Body Weight at Week 26(Week 0, Week 26)
Number of Hypoglycaemic Episodes(Weeks 0-26)
Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test(Week 0, Week 26)
Mean Actual Daily Insulin Dose(Week 26)