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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174681
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 11, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Glargine Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
Study Start Date : April 2003

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00174681

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

Layout table for additonal information Identifier: NCT00174681    
Other Study ID Numbers: HOE901_4042
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs