Tulip Study: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

Secondary objectives: The secondary objectives of this trial are to compare between the two treatment groups: * The variation in HbA1c between baseline and end of trial. * The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia. * Mean blood glucose levels at different times of the day. * The variation in weight and lipid in each group between baseline and end of trial. * The incidence of adverse events.

The registry classes the interventions as drug.

Who Took Part

The registry lists 390 planned participants were the target.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Type 2 diabetes. 24 ≤ BMI ≤ 35 kg/m2. Treated with OAD for at least 2 years. Treated with at least two oral antidiabetics including one sulphonylurea at the maximum tolerated dosages and metformin at the maximum tolerated dosages. Not treated with a glinide or thiazolidinedione.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: type 1 diabetics; insulin-treated type 2 diabetics or having previously received long-term insulin, or treated with a thiazolidinedione or glinide; history of hypersensitivity to the investigational product or to drugs with similar chemical structures.

How the Study Was Run

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

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.

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

It started in 2003-04.

It ran at 6 sites in Croatia (1), Czechia (1), France (1), Romania (1), Russia (1) and Slovenia (1).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 390 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.