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Posted by on Apr 11, 2016 in Diabetes mellitus | 0 comments

In a nutshell

This study examined whether insulin degludec is safe and effective when combined with metformin and liraglutide. The authors concluded that insulin degludec is safe and effective as an add-on therapy.

Some background

Patients with type 2 diabetes (T2D) initially produce insulin (hormone which lowers blood sugar levels) but it fails to work in the body. Drugs such as metformin (Glucophage) aim to help insulin work in the body. Eventually, however, insulin production decreases. Metformin can then be combined with drugs such as liraglutide (Victoza). However, the effectiveness of these drugs decreases over time as the pancreas stops producing insulin. Patients then require insulin therapy.

Insulin degludec (Tresiba) is an ultra-long-acting insulin which lasts for up to 40 hours. It is not known whether insulin degludec is safe or effective as an add-on therapy in T2D patients who have been treated with metformin and liraglutide.

Methods & findings

This study aimed to determine whether insulin degludec is safe and effective as an add-on therapy to metformin and liraglutide.  This study involved T2D patients with inadequately controlled blood glucose levels. Patients were randomly divided into two groups. 174 patients received once-daily insulin degludec, while 172 patients received a placebo (substance with no therapeutic efficacy). All participants were treated for 26 weeks. All participants were treated with 1.8 mg liraglutide and more than 1500 mg metformin.

HbA1c levels (average blood glucose levels over 3 months) were measured in all participants. Fasting plasma glucose (FPG, blood glucose levels after 8 hours without food or drink) was also measured.

After 26 weeks, the average change in HbA1c levels was greater for patients treated with insulin degludec (decrease of 1.04%) compared to placebo (decrease of 0.16%). Average FPG levels were lower in participants who received insulin degludec compared to the placebo group. After 26 weeks, participants receiving insulin degludec had gained an average of 2 kg, whereas the placebo group had lost an average of 1.3 kg.

The rate of hypoglycemia (dangerously low blood glucose levels) was low in both groups. However the rate of hypoglycemia was higher in participants receiving insulin degludec (0.57 episodes per year) compared to the placebo group (0.12 episodes per year). There were no episodes of severe hypoglycemia in either group.

The bottom line

This study concluded that the addition of insulin degludec to patients who are sub-optimally treated with metformin and liraglutide is safe and effective.

The fine print

A placebo rather than another anti-diabetic drug was used to compare the effectiveness of insulin degludec.

What’s next?

Consult your physician regarding the risks and benefits of insulin degludec as a combination treatment.

Published By :

Diabetes, Obesity and Metabolism

Date :

Mar 18, 2016

Original Title :

The effect of adding insulin degludec in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study).

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