Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)

What Was Tested

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

It had two arms (groups): one (active comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.

Who Took Part

The registry lists 892 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age ≥ 18 and ≤ 70 years. Type 2 diabetes patients with diabetes diagnosis at least 2 years. BMI ≥25 and ≤40 kg/m\^2. Willingness and ability to comply with the study protocol. Signed informed consent obtained prior any study procedure.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: known hypersensitivity/intolerance to insulin glargine or any of its excipients; history of hypoglycemia unawareness; unexplained hypoglycemia in the past 6 months.

How the Study Was Run

The set-up was 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2016-09-09 with completion listed for 2018-04-26.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of patients with at least one episode of hypoglycemia (time frame: 16 weeks).

It also tracked 11 secondary outcomes, for example Change from baseline in HbA1c, Change from baseline in Fasting Plasma Glucose, Change from baseline in Post Prandial Glucose, Change in body weight, Number of nocturnal hypoglycemic events and Number of severe hypoglycemic events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 892 people.

With 892 participants it is a large trial for this field.

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.