Birmingham, Alabama (PRWEB) February 28, 2013
*Achieve Clinical Research conducts Clinical Trials in Birmingham, Alabama. For more information about getting started with a Diabetes Clinical Trial, please visit our website or contact us directly at (205) 380-6434
BACKGROUND AND RATIONALE
Type 2 diabetes mellitus (T2DM) is a multi-organ disease characterized by defective insulin action in the liver, adipose tissue and skeletal muscle and a relative impairment of insulin secretion capacity. At diagnosis, subjects with T2DM have only 50% of their beta-cell function remaining and with progressing disease patients become profoundly insulin deficient requiring insulin therapy to restore glycaemic control.
In addition, a blunted secretion and/or action of incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP) from the gastro-intestinal tract in response to a meal are also characteristic of T2DM. GLP-1 is an important postprandial hormone secreted from the L-cells in the intestine with a stimulating effect on insulin secretion and an inhibitory role on glucagon secretion from the endocrine pancreas in a glucose-dependent manner.
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To confirm superiority of insulin degludec/liraglutide versus unchanged GLP-1 receptor agonist therapy in controlling glycaemia in insulin naive subjects with T2DM inadequately controlled on GLP-1 receptor agonist therapy in combination with metformin±pioglitazone±sulphonylurea.
To compare general efficacy and safety of insulin degludec/liraglutide versus unchanged GLP-1 receptor agonist therapy in insulin naive subjects with T2DM inadequately controlled with GLP-1 receptor agonist therapy in combination with metformin±pioglitazone±sulphonylurea after 26 weeks of treatment.
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
2. Type 2 diabetes mellitus
3. Male or female over 18 years of age
4. HbAlc 7.0-9.0% (53-75 mmol/mol) (both inclusive)
5. Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg OD Victoza® (liraglutide) or 10 microgram BID Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza (liraglutide) or 5 microgram BID Byetta (exenatide)) in combination with a stable daily dose of metformin (more than 1500 mg or documented maximum tolerated dose) ± stable daily dose of pioglitazone (more than30 mg) ±stable daily dose of sulphonylurea (more than half of the max approved dose according to local label) more than 90 days prior to screening visit (Visit 1)
6. BMI less than 40 kg/m^
7. Able and willing to adhere to the protocol including performing self measured plasma glucose profiles, to keep a trial diary and to use pre-filled pen device
For information about how to participate in this type 2 diabetes clinical trial, visit Achieve Clinical Research or contact us directly at (205) 380-6434