Tulip Study: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
This study has been completed.
Information provided by:
First received: September 9, 2005
Last updated: January 10, 2011
Last verified: January 2011
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.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174681
|Prague, Czech Republic|
|Moscow, Russian Federation|
Sponsors and Collaborators
|Study Director:||Valérie Pilorget, MD||Sanofi|