Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Sanofi
Treatments:
Insulin Glargine