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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec/liraglutide; Drug: insulin degludec

• Registration Number: NCT01392573
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Study Start: 2011-11-28
• Primary Completion: 2012-10-01
• Study Completion: 2012-10-04
• Disposition First Submitted: 2012-12-19
• Disposition First Submitted QC: 2012-12-19
• Disposition First Posted: 2012-12-24
• Results First Submitted: 2016-11-23
• Results First Submitted QC: 2016-11-23
• Results First Posted: 2017-01-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

Inclusion Criteria

• Subjects with type 2 diabetes
• HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
• Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
• BMI (Body Mass Index) more than or equal to 27 kg/m^2

Exclusion Criteria

• Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
• Impaired liver function
• Impaired renal function
• Screening calcitonin equal to or above 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 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
• Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)
• Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
• History of chronic pancreatitis or idiopathic acute pancreatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDegLira + metformin	insulin degludec/liraglutide	IDegLira was injected subcutaneously once daily for 26 weeks.
IDeg + metformin	insulin degludec	IDeg was injected subcutaneously once daily for 26 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Week 0, week 26	Observed mean change from baseline in HbA1c after 26 Weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight	Week 0, week 26	Observed mean change from baseline in body weight after 26 Weeks of treatment.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇭 St. Gallen, Switzerland