Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus

What Was Tested

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

Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose.

It had two arms (groups): Insulin Degludec - Insulin Glargine (active comparator) and Insulin Glargine - Insulin Degludec (active comparator).

The registry classes the interventions as drug.

More on the Plan

Cross-over, double dummy, randomized, clinical trial was carried out.

The sample size was calculated using the formula for clinical trials of mean differences with an "n" of 6 patients per group was obtained.

The clinical findings and laboratory tests included a metabolic profile and biosafety, which will be made at baseline.

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 30 years up to 65 years.

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

Examples of who could join: Patients with T2DM without treatment for at least 3 months Body mass index (BMI) from 25.0-34.9 kg/m2 Diagnosis of T2DM. Written informed consent.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: women pregnant or breastfeeding; untreated thyroid disease and/or uncontrolled hypertension \[≥150 systolic and diastolic ≥90\]; alanine aminotransferase (alt) and aspartate aminotransferase (ast) more than twice the normal range.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2013-11 with completion listed for 2015-07.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE) (time frame: 2 days).

It also tracked 1 secondary outcome, for example Glycemic Variability: Area Under the Curve of Glucose.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 12 people.

Its size is small, so on its own it can only give an early look.

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.