Status:
COMPLETED
Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief Summary
Primary Objective: To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period. Secondary O...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Insulin-naïve type 2 diabetes mellitus
- Type 2 diabetes mellitus diagnosed for at least 1 year
- Treated with at least one OAD (Metformin \[daily dose of at least 1000mg\], Sulfonylurea, glinides or alpha-glucosidase inhibitor) at stable dose for at least 3 months.
- HbA1c \> or = 7.0% and \< or = 10.5%
- BMI \< 40 kg/m²
- Ability and willingness to perform plasma glucose monitoring using the sponsor-provided glucose meter and patient diary at home
- Informed consent obtained in writing at enrolment into the study
- Willingness and ability to comply with the study protocol
- Exclusion criteria:
- Treatment with GLP-1 agonists or with DPP-IV inhibitors in the 3 months prior to study entry
- Treatment with TZD as monotherapy
- Diabetes mellitus other than Type 2 (e.g. secondary to pancreatic disorders, drugs or chemical agents intake...)
- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry)
- Impaired renal function: serum creatinine \> or =1.5 mg/dL (\> or = 133µmol/L) or \> or = 1.4 mg/dL (\> or = 124 µmol/L) in men and women, respectively
- History of sensitivity to the study drugs or to drugs with a similar chemical structure
- Impaired hepatic function (ALT and/or AST \> 3 x upper limit of normal range)
- Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
- Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted.
- Treatment with an investigational product in the 30 days prior to visit 1
- Alcohol or drug abuse in the last year
- Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patient's safety or limit the patient successful participation in the study (including night shift worker)
- 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 :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
708 Patients enrolled
Trial Details
Trial ID
NCT00949442
Start Date
July 1 2009
End Date
July 1 2012
Last Update
August 21 2012
Active Locations (87)
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1
Investigational Site Number 076-001
Fortaleza, Brazil, 60115-282
2
Investigational Site Number 076-006
Fortaleza, Brazil, 60430-370
3
Investigational Site Number 076-005
Porto Alegre, Brazil, 90035-170
4
Investigational Site Number 076-007
Rio de Janeiro, Brazil, 202110340