Efficacy/Safety Study of Amaryl®M [amount hidden] Twice Daily Versus Amaryl® [amount hidden] Both in Combination With Lantus® in Type 2 Diabetes Mellitus

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

It had two arms (groups): Amaryl group (active comparator) and Amaryl M group (experimental).

The registry classes the interventions as drug.

More on the Plan

There are several kinds of oral antidiabetic drugs (OADs) that are used in the treatment of patients with type 2 DM.

Among them, sulfonylurea and metformin are well-established first-line OADs.

However, as the beta cell dysfunction progresses over time, patients fail to achieve good glycemic control with OADs alone and need further treatment intensification, usually involving the introduction of insulin either alone or in combination with OADs.

Now, an OAD combined with bedtime insulin is one of the recommended treatment options for patients with type 2 DM and OAD failure.

Who Took Part

110 planned participants were the target.

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: Patients over 20 years old with type 2 DM. 21 kg/m2 ≤ BMI ≤ 30 kg/m2. Patents who need insulin add-on therapy based on investigator's discretion. Patients who would give the informed consent. Patients who can perform SMBG and record the data on the patient's diary.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening; pregnant or lactating females; history of drug or alcohol abuse.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

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

It started in 2009-05 with completion listed for 2010-11.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean change in HbA1c from baseline to the last visit (time frame: 16 weeks).

It also tracked 6 secondary outcomes, for example Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events, Response rate based on HbA1c and FPG levels measured at the last visit, Compliance, Frequency with hypoglycemic episode and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 110 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.