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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174681
First received: September 9, 2005
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Phase 4

Study Type: Interventional
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:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of subjects achieving HbA1c < 7% at the end of the study.

Estimated Enrollment: 390
Study Start Date: April 2003
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

Subjects fulfilling all of the following criteria will be eligible for inclusion in the trial:

  • Type 2 diabetes
  • 24 ≤ BMI ≤ 35 kg/m2
  • 7 % ≤ HbA1c ≤ 8 %
  • Treated with OAD for at least 2 years
  • Treated with at least two oral antidiabetics including one sulphonylurea at the maximum tolerated dosages and metformin at the maximum tolerated dosages
  • Not treated with a glinide or thiazolidinedione.
  • Capable of performing blood glucose self-monitoring and a self-injection of insulin.
  • Funduscopy within the previous year at the time of inclusion.

Exclusion Criteria:

Patient with any of the following criteria will not be included in the trial:

  • Type 1 diabetics
  • Insulin-treated type 2 diabetics or having previously received long-term insulin, or treated with a thiazolidinedione or glinide
  • Fasting blood glucose < 1.20 g/l.
  • Pregnancy (non-menopausal women must have a pregnancy test before the inclusion visit and effective contraception).
  • Lactation.
  • History of hypersensitivity to the investigational product or to drugs with similar chemical structures.
  • Systemic treatment with corticosteroids irrespective of the dose and irrespective of the previous or anticipated duration of treatment.
  • Treatment with another product under development in the 2 months preceding the date of inclusion in the study.
  • Subject likely to receive treatments prohibited in the protocol during the trial.
  • Cardiovascular, hepatic, neurological, endocrine or any other disease making it difficult to carry out the protocol or interpret the results.
  • Proliferative or rapidly progressive or unstable retinopathy for at least 6 months after treatment by surgery or laser, or requiring surgery or laser in the 3 months following inclusion in the study.
  • Hepatic impairment:ALT and/or AST more than three times the upper limit of normal at the initial assessment.
  • Renal insufficiency:Serum creatinine >177 µmol/l (>20 mg/l) or creatinine clearance <60 ml/min.
  • Previous or current history of alcohol or drug abuse.
  • Mental state rendering the subject incapable of understanding the nature, objectives and possible consequences of the trial.
  • Inability to undertake blood glucose self-monitoring and the injection of insulin alone.
  • Subject unable to accept the restrictions of the protocol (uncooperative, unable to attend the follow-up visits and probably incapable of completing the trial).
  • Subjects deprived of freedom by an administrative or judicial decision.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174681

Locations
Croatia
Sanofi-Aventis
Zagreb, Croatia
Czech Republic
Sanofi-Aventis
Prague, Czech Republic
France
Sanofi-Aventis
Paris, France
Romania
Sanofi-Aventis
Bucharest, Romania
Russian Federation
Sanofi-Aventis
Moscow, Russian Federation
Slovenia
Sanofi-Aventis
Ljubljana, Slovenia
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valérie Pilorget, MD Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00174681     History of Changes
Other Study ID Numbers: HOE901_4042
Study First Received: September 9, 2005
Last Updated: January 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014