Birmingham, AL, January 29, 2013 --(PR.com
)-- For information about how to participate in this type 2 diabetes clinical trial, visit Achieve Clinical Research or contact them directly at (205) 380-6434.
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.
Optimal glycaemic control is the treatment goal in subjects with T2DM, in order to prevent long-term complications associated with chronic hyperglycemia.
Despite the availability of several oral anti-diabetic drugs and insulin, a significant proportion of subjects with T2DM do not achieve the recommended blood glucose target levels. With the increasing incidence and prevalence of T2DM, there is an unmet medical need for new treatment regimens with improved efficacy, safety and convenience.
To confirm superiority of insulin degludec/liraglutide versus unchanged glucagon-like peptide-1 (GLP-1) receptor agonist therapy in controlling glycaemia in insulin naïve subjects with type 2 diabetes mellitus (T2DM) inadequately controlled on GLP-1 receptor agonist therapy in combination with metformin.
To compare general efficacy and safety of insulin degludec/liraglutide versus unchanged GLP-1 receptor agonist therapy in insulin naïve subjects with T2DM inadequately controlled with GLP-1 receptor agonist therapy in combination with metformin after 26 weeks of treatment.
A 26-week, multi-center, multinational, open-label, 2-arm parallel, randomized, treat-to-target trial in insulin naïve subjects with T2DM inadequately controlled on a maximum tolerated dose or maximum dose according to local label of GLP-1 receptor agonist and metformin.
Subjects will be randomized in a 2:1 manner into one of the two treatment arms:
Once daily insulin degludec/liraglutide added to pre-trial dose of metformin therapy or
Unchanged pre-trial GLP-1 receptor agonist in combination with metformin.
The randomization will be stratified according to pre-trial type of GLP-1 receptor agonist. The total duration of the trial is approximately 29 weeks consisting of 2 weeks screening period and 26 weeks treatment period and a follow-up visit 1 week after end of treatment. During the 26 week treatment period the subjects will have weekly contacts with the site.
Key Inclusion Criteria
Subjects diagnosed with type 2 diabetes mellitus
Male or female 18 years of age
HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
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 twice daily (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 (1500 mg or documented maximum tolerated dose) - 90 days prior to screening visit (Visit 1)
BMI (body mass index) of 40 kg/m2
Key Exclusion Criteria
Any use of oral anti-diabetic drugs (OADs) (except for metformin) 90 days prior to screening visit
Use of any drug (except metformin and GLP-1 receptor agonist) which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
Screening calcitonin of 50 ng/l
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularization procedures
Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator’s opinion
Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
History of chronic pancreatitis or idiopathic acute pancreatitis
*Achieve Clinical Research conducts Clinical Research Studies 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