Study TO Prevent Diabetes With Short-term Insulin Glargine Only

What Was Tested

The trial (not phased) is built around Insulin Glargine.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 2420 planned participants were the target.

It was open to people of any sex aged from 25 years up to 65 years.

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

Examples of who could join: All participants are voluntary and write informed consent 2 weeks before enrollment. Both male and female aged between \>= 25 and ≤ 65 years. Participants have the ability to use self-monitoring devices to measure their blood glucose level and practice self-insulin injection. Have the ability and willingness to complete the study logs and questionnaires. Pregnancy test of all child-bearing age women should be negative, and they agree to adopt contraceptive measures in the study process.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: with previous diagnosis of diabetes or application of hypoglycemic drugs; receiving cancer treatment in the past 5 years; preliminary diagnostic anti-hiv test result positive, with no serological testing.

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.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2011-01 with completion listed for 2013-10.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 2 secondary outcomes, for example FPG >= 7.0 for two times in a month.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 2420 people.

With 2420 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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