Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.

It had three arms (groups): Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD) (experimental), Insulins + Metformin (MET) + Thiazolidinedione (TZD) (experimental) and Insulins + Metformin (MET) + Sulfonylurea (SU) (experimental).

The registry classes the interventions as drug.

Who Took Part

390 actual participants took part.

It was open to people of any sex aged from 18 years up to 79 years.

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

Examples of who could join: 18 to 79 years of age, inclusive. Diagnosis of type 2 diabetes mellitus. Continuous treatment with therapeutic dosages of a thiazolidinedione (rosiglitazone or pioglitazone), metformin, and a sulfonylurea daily prior to entering the study. Fasting C-peptide concentration ≥ 0.27 ng/ml. Negative glutamic acid decarboxylase (GAD) antibodies.

The full record lists 9 inclusion and 19 exclusion criteria; among the exclusions: stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months; cardiac status new york heart association (nyha) iii-iv; chronic use of insulin: (more than 3 weeks of continuous use) in the past 12 months.

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.

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 2006-02 with completion listed for 2008-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12 (time frame: 12 weeks from Baseline).

It also tracked 6 secondary outcomes, for example Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime), Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia and Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 390 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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