Status:
COMPLETED
Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Type 2 diabetes mellitus
- Patients being treated with Lantus once daily, Levemir once or twice daily or NPH insulin once or twice daily as a single insulin for at least three months 10.0% \> or = HbA1c \> or = 7.5%
- BMI \< or = 40 kg/m²
- If patients are taking oral antidiabetics (OADs), the dose must be stable for at least 1 month
- Ability and willingness to perform blood glucose monitoring using a blood glucose meter and ability and willingness to use a patient diary
- Provision of written informed obtained prior to enrollment in the study
- Exclusion criteria:
- Type 1 diabetes mellitus
- Current or previous treatment with an insulin other than basal insulin (biphasic insulin, short acting insulin, rapid-acting insulin analogue)
- Treatment with GLP-1 receptor agonists or with DPPIV inhibitors in the 3 months before screening
- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before screening or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus exam performed in the 2 years prior to screening)
- Unable or unwilling to enter either of the treatment arms
- Women who are pregnant or lactating (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
- History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
- Treatment with systemic corticosteroids in the 3 months prior to study entry
- Treatment with any investigational product in the 2 months prior to study entry
- Current treatment with any non-selective beta-blockers
- Likelihood of requiring treatment during the study period with drugs not permitted by this clinical protocol
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at screening
- Impaired renal function as shown by serum creatinine \>135 µmol/l in men and \> 110 µmol/l in women at screening
- History of drug or alcohol abuse
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- Patient unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study
- Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved
- 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 :
December 1 2012
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT00965549
Start Date
July 1 2009
End Date
December 1 2012
Last Update
January 8 2013
Active Locations (74)
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1
Investigational Site Number 204
Campbelltown, Australia, 2560
2
Investigational Site Number 205
Campbelltown, Australia, 2560
3
Investigational Site Number 201
Caulfield, Australia, 3162
4
Investigational Site Number 210
Daw Park, Australia, 5041