In a nutshell
This study evaluated the outcomes of cotadutide (MEDI0382) treatment in patients with type 2 diabetes (T2D) and obesity. This study concluded that cotadutide treatment improved glycemic (blood sugar) control and weight loss in these patients.
Some background
T2D is commonly associated with obesity. About 70% of patients with T2D also have non-alcoholic fatty liver disease (NAFLD). This disease is characterized by a build-up of fat in the liver. High amounts of fat in the liver can make it harder for the body’s cells to respond to insulin (insulin resistance). Over time, fatty liver disease can worsen. Liver scarring (fibrosis) may develop, which can severely damage the liver. As scarring builds up over time, it can become irreversible (cirrhosis).
Cotadutide is an experimental medication that affects two different types of receptors in the body called GLP-1 and glucagon receptors. Previous studies suggest that cotadutide may be more effective than other treatments that target only one of these receptors. Whether cotadutide can improve the long-term outcomes of patients with T2D remains unclear.
Methods & findings
This study included 834 adults with T2D. All patients were already taking metformin (Glucophage) and had inadequately controlled blood glucose. All patients were also overweight or obese. This study divided patients into three groups. 612 patients received one of three different doses of cotadutide (Group A). 110 patients received liraglutide (Victoza; Group B). 112 patients received a placebo (substance with no active effect). 78.2% of patients finished treatment. Patients were treated for 54 weeks and followed up for an average of 4 weeks.
After 54 weeks of treatment, HbA1c (blood glucose control over the past 2-3 months) levels significantly decreased in Group A compared to placebo (1.03 – 1.19 units vs. 0.45 units). Significantly more patients in Group A achieved HbA1c levels less than 7.0% compared to placebo (55 – 58% vs. 24%). However, there was no significant difference between Groups A and B who achieved HbA1c levels less than 7.0% (57.8% vs. 61.5%).
After 54 weeks of treatment, body weight significantly decreased in Group A than placebo (3.70 – 5.02% vs. 0.68%). Only the highest dose of cotadutide (300 µg)significantly reduced body weight compared to Group B (5.02% vs. 3.33%). Significantly more patients given the highest dose of cotadutide lost 5% or more body weight compared to Group B (46.5% vs. 30.8%).
Fatty liver index also significantly decreased in Group A compared to placebo (8.08 – 8.29 units). Triglyceride levels also significantly decreased by 4.93 – 9.75 units in Group A compared to placebo, which increased triglyceride levels by 2.71 units.
More patients in Group A reported side effects than Group B (73.0 – 80.5% vs. 61.8%) and placebo (61.6%). The most common side effects in Group A were nausea and vomiting. These were significantly more common in Group A than Group B and placebo.
The bottom line
This study concluded that cotadutide treatment improved glycemic (blood sugar) control and weight loss in patients with obesity, fatty liver, and T2D.
The fine print
Patients in Group B knew that they received liraglutide, while patients in Group A did not know what treatment they received. Also, most patients in this study were ethnically white. Thus, these results may not apply to all patients. More studies are needed to confirm these results.
Published By :
Diabetes Care
Date :
May 21, 2021