Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes

What Was Tested

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

In recent years, with the further research of the pathogenesis of diabetes mellitus and the mechanism of oral antidiabetes drugs, the early combination therapy of oral antidiabetes drugs and insulin is getting paid more and more attention.

It had two arms (groups): Combination therapy (experimental) and monotherapy (active comparator).

The patients allocated into this arm will receive the monotherapy of subcutaneous injection of premixed insulin (Biosynthetic Human Insulin Injection, Novolin 30R) twice daily for 3 months.

The registry classes the interventions as drug.

More on the Plan

Male or female with type 2 diabetes mellitus 2. 35 years old≤age≤65 years old 3. 19kg/m2≤BMI≤32kg/m2 4.

Not participated in other clinical studies within the past 3 months 7.

Well know this study and sign the informed consent form Exclusion criteria: 1.

Unable to sign the informed consent form 2.

Who Took Part

160 actual participants took part.

It was open to people of any sex aged from 35 years up to 65 years.

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

Examples of who could join: Male or female with type 2 diabetes mellitus. 35 years old≤age≤65 years old. Not participated in other clinical studies within the past 3 months. Well know this study and sign the informed consent form.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: unable to sign the informed consent form; treated by insulin, even transient usage within the past 1 year; type 1 diabetes mellitus.

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.

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 2008-10 with completion listed for 2011-08.

It ran at 8 sites in China (8).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example MBG, SDBG, MAGE and MODD in the 48th CGMS, Incidence of hypoglycemia and severe hypoglycemia and Weight change.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 160 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.