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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174681
• Other study ID #: HOE901_4042
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: January 10, 2011
• Start date: April 2003

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine

Locations

Country	Name	City	State
Croatia	Sanofi-Aventis	Zagreb
Czech Republic	Sanofi-Aventis	Prague
France	Sanofi-Aventis	Paris
Romania	Sanofi-Aventis	Bucharest
Russian Federation	Sanofi-Aventis	Moscow
Slovenia	Sanofi-Aventis	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Croatia,  Czech Republic,  France,  Romania,  Russian Federation,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects achieving HbA1c < 7% at the end of the study.