Normalization of Fasting Glucose and the Incidence of Restenosis After Peripheral Angioplasty

What Was Tested

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

Methodology: This is a randomized, open-label, clinical trial comparing two regimens of insulin therapy having as an outcome measure the incidence of angiographic restenosis at 6 months after peripheral angioplasty.

It had two arms (groups): long-acting insulin plus analogues (active comparator) and long-acting insulin and oral agents (active comparator).

Three administrations of regular insulin or short acting insulin analogues before meals combined with long-acting insulin analogue glargine in the evening.

Treatment will be once-daily long-acting insulin and oral antidiabetic agents.

The registry classes the interventions as drug.

More on the Plan

Seventy consecutive patients with type 2 diabetes mellitus and peripheral arterial disease (PAD) defined at angiographic evaluation and/or clinical manifestations, will be admitted to their Institute to undergo PTA procedure.

After the procedure, suitable patients will be screened to enter the study.

One week following hospital discharge after PTA procedure, patients will return to the Diabetology Outpatients Clinic to be randomly assigned to receive intensified insulin therapy or standard care.

Prestudy treatments could be diet alone, oral antidiabetic agents, or once-daily insulin and oral antidiabetic agents.

Who Took Part

Enrollment: 46 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Age between 30 and 75 years. Once daily insulin and OAD. Critical limb ischemia (CLI) defined as. Persistent, recurring rest pain requiring analgesia and an ankle systolic pressure \<50 mm Hg and/or toe systolic pressure \<30 mm Hg or TcPO2 \<30 mm Hg. Ulceration, gangrene, or nonhealing wounds of the foot with ankle systolic pressure \<50 mm Hg or toe systolic pressure \<30 mm Hg or TcPO2 \<30 mm Hg.

The full record lists 14 inclusion and 14 exclusion criteria; among the exclusions: type 1 diabetes, defined as positivity for gad antibodies measured by radiobinding assay; unwilling to inject insulin or to perform a correct self monitoring of blood glucose; acute limb ischemia.

How the Study Was Run

The set-up was 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 2008-12 with completion listed for 2010-11.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Identification of new peripheral markers predictive of restenosis.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 46 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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