Phase 3
Completed N=413
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01392573 ↗Enrolled (actual)
413
Serious AEs
4.5%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) — -1.90; -0.89 percentage of glycosylated haemoglobin — p=<0.0001
◆ Published Evidence
Highly cited
253citations · ~21 / year
Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira).
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.
Linked Publications (5)
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Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira).
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A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges.
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EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES.
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Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone.
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Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) |
-1.90; -0.89 | <0.0001 sig |
| SECONDARY Change in Body Weight |
-2.7; 0.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01392573) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.