Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin (regular human).

The effects of PN2034 on HbA1c, fasting plasma glucose (FPG), and lipid levels will also be measured.

The registry classes the interventions as drug.

Who Took Part

90 planned participants were the target.

It was open to people of any sex aged from 21 years up to 65 years.

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

Examples of who could join: Diagnosed with type 2 diabetes mellitus. 21 to 65 years of age. BMI 26-43 kg/m2. Direct bilirubin \< 1.5x the upper limit of normal (ULN). Surgically sterile,postmenopausal,or using adequate contraception and have a negative pregnancy test at Screening.

The full record lists 14 inclusion and 18 exclusion criteria; among the exclusions: diagnosed with type 1 diabetes mellitus or has a history of ketoacidosis; treatment with tzds or any other oral antidiabetic (excluding metformin) within 3 months prior to screening or during study treatment; change in lipid-lowering medication within 2 months of screening.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

It started in 2005-05 with completion listed for 2007-04.

It ran at 18 sites in United States (18).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety.

It also tracked 3 secondary outcomes, for example Effect on HbA1c levels, Effect on FPG levels and Effect on lipid levels.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 90 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.