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

Summary

Primary objective: The primary objective of this trial is: * To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and dietary measures in type 2 diabetics whose blood glucose control is acceptable but not optimal on maximum oral treatment, based on the number of patients achieving a HbA1c value \< 7% at the end of treatment. 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.

Timeline

Start

2003-04

Primary completion

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Completion

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Drugs

Indications