Tulip Study: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT00174681|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 11, 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Insulin Glargine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes|
|Study Start Date :||April 2003|
- Percentage of subjects achieving HbA1c < 7% at the end of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174681
|Prague, Czech Republic|
|Moscow, Russian Federation|
|Study Director:||Valérie Pilorget, MD||Sanofi|