Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia

What Was Tested

The trial (phase 4) is built around Insulin Glargine and Insulin Aspart.

It had two arms (groups): Insulin glargine (active comparator) and Insulin degludec (experimental).

Each treatment arm last for 12 months - 3 months of run-in/cross-over and 9 months of maintenance. Patients will be randomised (1:1) to treatment with basal-bolus therapy with insulin aspart/degludec or insulin aspart/glargine in random order. After 12 months of treatment patients will cross-over to the other basal-bolus therapy. Insulin degludec and insulin glargine is administered once daily at the evening meal and insulin aspart is administered three times daily before the main meals.

Each treatment arm last for 12 months - 3 months of run-in/cross-over and 9 months of maintenance. Patients will be randomised (1:1) to treatment with basal-bolus therapy with insulin aspart/degludec or insulin aspart/glargine in random order. After 12 months of treatment patients will cross-over to the other basal-bolus therapy. Insulin degludec and insulin glargine is administered once daily at the evening meal and insulin aspart is administered three times daily before the main meals.

The registry classes the interventions as drug.

More on the Plan

Study design and intervention: A controlled, cross-over multi-centre study in a Prospective, Randomised, Open, Blinded Endpoint (PROBE) design.

Each treatment period last for 12 months.

Patients will be randomised to treatment with basal-bolus therapy with insulin aspart/degludec or insulin aspart/glargine in random order.

Endpoints will be assessed during the last 9 months of each treatment arm.

Who Took Part

Enrollment: 149 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: One or more episodes of nocturnal severe hypoglycaemia during the preceding two years. Willingness to a once daily (OD) regimen concerning insulin degludec and insulin glargine. Willingness to do self-monitoring of blood glucose (SMBG) and keep a diary. Signed informed consent.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: history of primary and secondary adrenal insufficiency, growth hormone deficiency, or untreated myxoedema; history of unstable angina or major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last three months); heart failure, new york heart association (nyha) class iv.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-01 with completion listed for 2019-02-28.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Symptomatic nocturnal hypoglycaemia (time frame: 9 months (3-12) of each treatment period).

It also tracked 9 secondary outcomes, for example Severe hypoglycaemia (total, night-time, daytime), Any nocturnal hypoglycaemia (incl. asymptomatic/silent events), Any daytime hypoglycaemia (symptomatic, asymptomatic/silent and severe), Any CGM recorded hypoglycaemia (symptomatic, asymptomatic/silent and severe), Change in HbA1c and Change in glycaemic variability.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 149 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.