Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 352 planned participants were the target.

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: Diagnosis of type 2 diabetes mellitus for at least six months. Ability to understand and willingness to adhere to and be compliant with the study protocol.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: stroke, myocardial infarction (mi), coronary artery bypass graft (cabg), percutaneous transluminal coronary angioplasty (ptca) or angina pectoris within the last 12 months; treatment with non-selective beta-blockers (including ocular); acute infection.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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 2001-12 with completion listed for 2005-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.

It also tracked 8 secondary outcomes, for example Compare occurrence of hypoglycemia, Compare change in body weight, Compare change in FPG, Compare change in serum lipid profile, Compare change in HRQOL and Compare cost of therapy for hyperglycemia treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 352 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.