A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

This study compares the effect on blood sugar levels of two medicines: insulin degludec and insulin glargine in people with type 2 diabetes.

Participants will be treated with insulin degludec and insulin glargine during two different periods.

Which treatment participants get first is decided by chance.

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

Participants will receive insulin degludec in period 1 and 2 in a cross-over manner.

Participants will receive insulin glargine in period 1 and 2 in a cross-over manner.

The registry classes the interventions as drug.

Who Took Part

498 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: Male or female, age greater than or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening. Subjects fulfilling at least one of the below criteria:. Experienced at least one severe hypoglycaemic episode within the last year prior to screening (according to the American Diabetes Association definition, January 2018)\*. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 at screening.

The full record lists 17 inclusion and 3 exclusion criteria; among the exclusions: anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2018-10-02 with completion listed for 2019-12-20.

It ran at 67 sites in United States (34), Canada (10), Slovakia (10), South Africa (7), Poland (5) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Time Spent in Glycaemic Target Range [amount hidden]/dL ([amount hidden]/L) Both Inclusive, Using Flash Glucose Monitoring (FGM).

It also tracked 5 secondary outcomes, for example Level of Glycated Haemoglobin (HbA1c) - Percentage, Level of Glycated Haemoglobin (HbA1c) - mmol/Mol and Mean Glucose Levels Using Flash Glucose Monitoring (FGM).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 498 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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