Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/21/2018 |
Start Date: | May 23, 2011 |
End Date: | November 22, 2012 |
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
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.
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.
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
We found this trial at
130
sites
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