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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014