Type 2 diabetes

Insulin glargine non-inferior to insulin degludec: BRIGHT

A head-to-head study of insulin glargine (300 U/ml; Toujeo) versus insulin degludec (100 U/ml; Tresiba) in insulin-naïve adults with type 2 diabetes has found similar glycaemic control between the two second-generation basal insulin analogues.

But the open-label, treat-to-target multinational BRIGHT study presented at the 2018 ADA Scientific Sessions in Orlando, Florida, found hypoglycaemic events were lower with insulin glargine during the insulin titration phase of the study.

The trial involved 929 adults with type 2 diabetes with a baseline HbA1c of between 7.5 and 10.5%. Patients were randomised to receive once daily insulin glargine at a dose of 300U/ml or insulin degludec 100 U/ml after they had failed to receive adequate control with oral anti-hyperglycaemic agents.

Presenting the findings of the 24-week study to the conference, Associate Professor Alice Cheng from the Division of Endocrinology and Metabolism at the University of Toronto, noted that the average duration of diabetes was about 10 years for both patient groups.

“I think this speaks to the point about when we are initiating insulin in our patients with type 2 diabetes and I think that is something we have got to change in the future,” she told the meeting.

Results showed that over 24 weeks insulin glargine met the primary endpoint of non-inferiority HbA1c level reduction compared to patients receiving insulin degludec (difference between treatments of 0.05 percent; 95% CI -0.15 – 0.05%; non-inferiority margin of 0.3%).

“Median baseline HbA1c was about 8.6 to 8.7% and within the first 12 weeks of the study that HbA1c came down close to 7% and was achieved by 24 weeks,” Professor Cheng told delegates.

She said both insulins also behaved very similarly in terms of 8-point self-measured plasma glucose (SMPG) profiles, 24-hr SMPG or fasting SMPG with most of the improvements occurring in the first 12 weeks.

“As a clinician I’d like to point out the fact that basal insulin, when used properly and adequately titrated, works.”

Hypoglycaemia at anytime over 24 hours and nocturnal hypoglycaemia were similar between the two insulin groups for the full study period (0-24 weeks) and during the maintenance period (12-24 weeks).

“In previously insulin-naïve people with inadequately controlled type 2 diabetes, insulin glargine 300 U/ml and insulin degludec 100 U/ml provided similar glycaemic control accompanied by comparable hypoglycaemia during the full study period,” she concluded.

However there was less hypoglycaemia with insulin glargine 300 U/ml versus insulin degludec 100 U/ml in the first 12 weeks of the study.

During this period, confirmed hypoglycaemia event rates were 10.47 per patient per year with insulin degludec 100 U/ml versus 8.08 with insulin glargine 300 U/ml at the ≤70mg/dL threshold (p=0.023) and 0.86 versus 0.49 favouring insulin glargine at <54mg/dL (p=0.038).

No specific safety concerns were reported and only one severe hypoglycaemic event occurred during the entire study.

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