Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

Primary objective: To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level Secondary objective: To compare the incidence of hypoglycemia in each treatment group.

It had three arms (groups): 1 (active comparator), 2 (active comparator) and 3 (experimental).

The registry classes the interventions as drug.

Who Took Part

99 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Type 2 diabetes for at least 6 months. BMI \< 30 kg/m². Patients who is willing to monitor BG using SMBG.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: type 1 diabetes; clinical evidence of active liver disease, or serum alt 3 times the upper limit of the normal range; history of alcohol or other substance abuse.

How the Study Was Run

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

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

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

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 2008-05 with completion listed for 2009-12.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c values (time frame: At baseline to end of treatment).

It also tracked 3 secondary outcomes, for example Hypoglycemia events and Fasting Blood Glucose level.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 99 people.

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.