MAD/Phase IIa T2D study publication available
A combined multiple-ascending dose (MAD) and Phase IIa study in n=112 patients with controlled type 2 diabetes
As of today you can access a new paper published in The Lancet on 22 June 2018 on a combined multiple-ascending dose (MAD) and Phase IIa study in n=112 patients with controlled type 2 diabetes (HbA1c levels between 6.5–8.5%) via the Publications section of our website.
This randomised, placebo-controlled, double-blind study was set up in a multi-centre environment (11 sites in Germany) and designed to assess the efficacy, tolerability and safety of a balanced glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist developed to provide glycaemic control and weight loss.
The compound’s development was triggered by the unmet medical need for pharmacological therapies that target both obesity and hyperglycaemia.
27 out of 112 patients were enrolled at CRO’s dedicated Phase I unit with recruitment rates of up to 7 patients per month, making CRO the best-recruiting centre. Assessed outcomes included glucose area under the curve at 0-4h after a mixed-meal tolerance test (MMTT), abdominal MRI scans and change in body weight from baseline to end of study.
All in all the study drug showed a high potential for reduction of blood glucose and body weight in individuals with type 2 diabetes. Furthermore safety and tolerability of once-daily dosing in the given study population could be demonstrated.