In a nutshell
The current study examined the safety and efficacy of albiglutide (Tanzeum) when used in combination with metformin (Glucophage) and glimepiride (Amaryl) in type 2 diabetes.
Some background
Type 2 diabetes is a progressive disease. While blood glucose (sugar) levels may initially be controlled by diet and exercise alone, eventually patients will need glucose-lowering medications. Metformin increases the body’s sensitivity to insulin (the hormone needed to break down glucose) and is generally the first medication used. When this fails to control blood glucose, other medications are added. Glimepiride also increases the sensitivity to insulin, and is often added to metformin.
Albiglutide is a treatment that increases the amount of insulin the body produces. Albiglutide may be an effective treatment to use in combination with metformin and glimepiride.
Methods & findings
The current study examined whether a combination treatment including albiglutide lowered blood glucose levels compared to a combination treatment including pioglitazone (Actos). Pioglitazone increases the body’s sensitivity to insulin. 657 type 2 diabetic patients were randomly divided into 3 groups. 269 patients in Group 1 received albiglutide, glimepiride, plus metformin. 273 patients in Group 2 received pioglitazone, glimepiride, plus metformin. 115 patients in Group 3 received a placebo (a substance with no effect on the body used for comparison), glimepiride, plus metformin. HbA1c (average blood glucose over 3 months) levels, fasting blood glucose (levels after a period without food or drink) levels, and body weight were compared from the start of treatment (baseline) to those after 52 weeks of treatment. The number of adverse events were measured in each group.
HbA1c levels decreased by an average of 0.55% in Group 1, by 0.80% in Group 2, and increased by 0.33% in Group 3. Fasting blood glucose decreased by an average of 0.69 mmol/l in Group 1, by 1.74 mmol/l in Group 2, and increased by 0.64 mmol/l in Group 3. Patients in both Groups 1 and 3 lost an average of 0.4 kgs, while patients in Group 2 gained 4.4 kg.
Gastrointestinal side effects (such as nausea, vomiting, and diarrhea) occurred in 33.6% of Group 1, 26.0% of Group 2, and 17.4% of Group 3. Hypoglycemia (dangerously low blood glucose) was experienced by 14% of Group 1, 25% of Group 2, and 14% of Group 3.
The bottom line
This study concluded that albiglutide was safe and effective as a third treatment added on to glimepiride and metformin in type 2 diabetes.
The fine print
This study was funded by GlaxoSmithKline, the manufacturers of albiglutide.
Published By :
Diabetes, Obesity and Metabolism
Date :
Nov 19, 2014