Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Insulin Glargine.

It had two arms (groups): Sequence 1 (experimental) and Sequence 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: age \< 20 years at written informed consent;; diabetes mellitus (dm) other than t1dm;; body mass index (bmi) \> 35.0 kg/m2 at screening visit.

How the Study Was Run

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

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

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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 2012-09 with completion listed for 2013-08.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in 24-hour blood glucose profile measured by continuous glucose monitoring (time frame: Baseline, Day 28, Day 56).

It also tracked 4 secondary outcomes, for example Hypoglycemia categorized by the definition of American Diabetes Association, Change in fasting plasma glucose from baseline to each treatment end by treatment, Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment and Change in HbA1c from baseline to each treatment end by treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 20 people.

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

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, all human trials.