Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes

What Was Tested

This registered not phased trial tested Insulin Glargine.

It had two arms (groups): Glargine (experimental) and metformin-based Oral Antidiabetic Drugs (experimental).

The registry classes the interventions as drug.

More on the Plan

Hyperglycemia may aggravate these defects, a feature known as glucose toxicity.

HbA1c were measured before intensive insulin injection.

After discharge, patients will be randomized to receive basal insulin injection or metformin-based OADs for further management.

Patients will be followed in their clinics and adjust their medication according to their blood glucose levels.

Who Took Part

The registry lists 47 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Newly diagnosed type 2 diabetic patients. Those who age between 30 and 70 years old and can inject insulin by themselves.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: established type 1 diabetes or positive anti-glutamic acid decarboxylase antibody;; malignancy, pregnancy or lactating;; history of ketoacidosis;.

How the Study Was Run

Design: 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.

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 2009-02 with completion listed for 2011-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycosylated Hemoglobin (HbA1c) at month 6 (time frame: month 6). Change From Baseline in Glycosylated Hemoglobin at month 6 (time frame: Baseline and month 6).

It also tracked 39 secondary outcomes, for example Glycosylated Hemoglobin at month 12, Change From Baseline in Glycosylated Hemoglobin at month 12, Fasting Plasma Glucose at week 2, Fasting Plasma Glucose at week 4, Fasting Plasma Glucose at week 8 and Fasting Plasma Glucose at week 12.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 47 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.