Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

It had two arms (groups): Insulin glargine (experimental) and Lispro mix (active comparator).

The registry classes the interventions as drug.

More on the Plan

The planned duration of enrollment is 6 months.

The study consists of 2 weeks screening phase and a study period that was planned to be 24 weeks.

Who Took Part

212 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: Patients must have given their signed informed consent. Males or females between 18 and 79 years of age. Diagnosis of type 2 diabetes mellitus for at least one year. Patients must have BMI of \> 25 kg/m2 at baseline. Ability and willingness to perform SMBG profiles using a plasma glucose meter at least twice a day.

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: patients, who have had stroke, mi, coronary artery bypass graft (cabg), percutaneous transluminal coronary angioplasty (ptca) or angina pectoris within the last 12 months; patients on non-selective beta blockers (including ocular); patients with acute infections.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2001-07 with completion listed for 2002-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline in hemoglobin A1c (HbA1c) levels at week 24 (time frame: 24 weeks).

It also tracked 5 secondary outcomes, for example Change from baseline in fasting plasma glucose (FBG) values at week 24, Change from baseline in serum lipid values at week 24 and Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 212 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 and the Insulin Lispro compound page, all human trials.