Status:
COMPLETED
Tulip Study: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
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 optimi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00174681
Start Date
April 1 2003
Last Update
January 11 2011
Active Locations (6)
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1
Sanofi-Aventis
Zagreb, Croatia
2
Sanofi-Aventis
Prague, Czechia
3
Sanofi-Aventis
Paris, France
4
Sanofi-Aventis
Bucharest, Romania