Status:
COMPLETED
Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary Objective: To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen. Secondary Objective: To demonstrat...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months:
- Sub-optimal: HbA1c level \>7% and fasting blood glucose \<130mg/dL
- Male or Female ≥18 years old
- Body Mass Index (BMI) \<40
- 10% ≥HbA1c ≥7%
- If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months
- Patients willing to sign data release consent form
- Exclusion criteria:
- Diabetes other than T2DM
- Enrolled in other clinical trials
- Previous treatment with an insulin other than insulin glargine
- Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or with Di Peptidyl Peptidase 4 (DPP-IV) inhibitors
- Pregnant or lactating women
- Contraindicated to Lantus (insulin glargine) / Apidra (insulin glulisine) / Novomix 30 (insulin aspart)
- Treatment with systemic corticoid steroids within the last 3 months prior to study enter
- Treatment with any investigational product within the last 3 months prior to study entry
- 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 :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT01212913
Start Date
August 1 2010
End Date
May 1 2012
Last Update
July 8 2013
Active Locations (1)
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1
Administrative Office
Seoul, South Korea