Viewing Study NCT00174681



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Study NCT ID: NCT00174681
Status: COMPLETED
Last Update Posted: 2011-01-11
First Post: 2005-09-09

Brief Title: Tulip Study Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
Sponsor: Sanofi
Organization: Sanofi

Study Overview

Official Title: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
Status: COMPLETED
Status Verified Date: 2011-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None