Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

It had two arms (groups): 1 (experimental) and 2 (experimental).

4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation 8 week follow up period.

4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation 8 week follow up period.

The registry classes the interventions as drug.

Who Took Part

The registry lists 142 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 2 Diabetes Mellitus. One or more oral antihyperglycemic medications.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: have not taken insulin within 6 months of entry into study; have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry; have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry.

How the Study Was Run

The set-up was randomized, crossover 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.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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 2007-02 with completion listed for 2008-05.

It ran at 19 sites in United States (6), Spain (5), India (4), Brazil (2) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint (time frame: 56 weeks).

It also tracked 14 secondary outcomes, for example Mean change in HbA1c from baseline to various timepoints, Patient-reported outcomes of W-BQ12, Hypoglycemia rate, Changes in body weight, Adverse events and Safety as assessed by total pulmonary function testing and fasting lipid profile.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 142 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.