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

NCT00174681 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2011-01-11

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine

Sponsors & Collaborators

Principal Investigators

  • Valérie Pilorget, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30

Countries

  • Croatia
  • Czechia
  • France
  • Romania
  • Russia
  • Slovenia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00174681 on ClinicalTrials.gov