Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2)
NCT ID: NCT00659477
Last Updated: 2010-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
117 participants
INTERVENTIONAL
2008-03-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single arm
insulin glargine
once daily
Interventions
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insulin glargine
once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients treated NPH insulin with stable dosage of OADs (Oral antidiabetic drugs) for at least 2 months prior to study start and OADs treatment with metformin at least 1,7 g /day in combination with sulfonylurea or glinides.
* Patients must have a HbA1c range of \>= 4,5% ( 6,2% DCCT/Diabetes Control and Complication Trials) and \<= 8% ( 9,4 % DCCT/Diabetes Control and Complication Trials)
* Ability and willingness to perform continuous glucose monitoring system / CGMS (examination within the study)
* Written informed consent obtained prior to enrollment in the study
* Women are either not of childbearing potential or women of childbearing potential must not be pregnant and must use a reliable contraceptive measure for the duration of the study
Exclusion Criteria
2. Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable rapidly progressing retinopathy that may require photocoagulation or surgery during the study.
3. Pregnant 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 micromol/L in men and \>/= 124 micromol/L in women at study entry
11. History of drug or alcohol abuse in the last year
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. Use of insulin glargine outside the scope of the current SPC (Summary of Product Characteristics)
16\. Patients included in other clinical studies
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Zuzana Priborska, MD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Prague, , Czechia
Countries
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References
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Zdarska DJ, Kvapil M, Rusavy Z, Krcma M, Broz J, Krivska B, Kadlecova P. Comparison of glucose variability assessed by a continuous glucose-monitoring system in patients with type 2 diabetes mellitus switched from NPH insulin to insulin glargine: the COBIN2 study. Wien Klin Wochenschr. 2014 Apr;126(7-8):228-37. doi: 10.1007/s00508-014-0508-6. Epub 2014 Feb 22.
Other Identifiers
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EudraCT #: 2007-003393-25
Identifier Type: -
Identifier Source: secondary_id
LANTU_L_02673
Identifier Type: -
Identifier Source: org_study_id