Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

This trial is conducted in Africa and Asia.

It had two arms (groups): IDegAsp U100 BID (experimental) and BIAsp U100 BID (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 263 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: Subjects diagnosed (clinically) with type 2 diabetes mellitus prior to day of screening (Visit 1). Treated with any pre-mix/self-mix or basal insulin regimen for at least 90 days prior to the day of screening (Visit 1). Intention to fast (daytime, i.e., between dawn and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting. Willing to give blood during Ramadan.

The full record lists 7 inclusion and 1 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2016-01-04 with completion listed for 2016-09-04.

It ran at 32 sites in India (9), South Africa (9), Algeria (4), United Arab Emirates (4), Lebanon (3) and Malaysia (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (%) (Glycosylated Haemoglobin) (time frame: From week 0 to end of Ramadan (day 29 of Ramadan)).

It also tracked 6 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG), Change in Fructosamine and Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 263 people.

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

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