A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine [amount hidden] in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

This trial is conducted in Europe and North America.

Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1609 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.

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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 2017-03-13 with completion listed for 2019-02-13.

It ran at 229 sites in United States (156), Germany (12), Canada (9), Hungary (9), Poland (9) and Greece (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (time frame: 36 Weeks).

It also tracked 15 secondary outcomes, for example Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks), Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks), Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks), Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks), Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks) and Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 1609 people.

With 1609 participants it is a large trial for this field.

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.