/A

• Conditions: Type 2 diabetes mellitus

• Registration Number: EUCTR2007-003393-25-CZ
• Lead Sponsor: sanofi-aventis, s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Men or women, aged from 18 to 80 years inclusive
2.Diabetes type 2
3.Patients treated NPH insulin with stable dosage of OADs for at least 2 months prior to study start and OADs treatment with metformin at lest 1,7 g /day in combination with sulfonylurea or glinides..
4.Patients must have a HbA1c range of = 4,5% ( 6,2% DCCT) and = 8% ( 9,4 % DCCT)
5.Ability and willingness to perform CGMS
6.Written informed consent obtained prior to enrollment in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Fasting value C peptide = 400 pmol/l
2.Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months retinopathy that may require photocoagulation or surgery during the study
3.Pregnancy women or women planning gravidity during clinical study protocol
4.Breast-feeding
5.History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
6.Treatment with systemic corticosteroids in the 3 months prior to study entry and during study and other treatment, that can significantly have impression to glycaemia.
7.Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
8.Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
9.Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
10.Impaired renal function as shown by serum creatinine >/= 133 ?mol/L in men and >/= 124 ?mol/L 1 in women at study entry
11.History of drug or alcohol abuse in the last
12.Mental condition causing the patient unable to understand the nature, scope and possible consequences of the study
13.Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
14.Patient is the investigator or any sub-investigator, research assistant, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
15.Use of insulin glargine outside the scope of the current SPC (Summary of Product Characteristics);
16.Patients included in other clinical studies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified