Status:
COMPLETED
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2...
Detailed Description
The maximum study duration was up to approximately 58 weeks per participant, consisting of: * up to 2 week screening period * 6-month comparative efficacy and safety treatment period * 6-month compar...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Participants with type 2 diabetes mellitus
- Substudy inclusion criteria:
- Completion of the 6-month study period in main study (Visit 10)
- Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)
- Exclusion criteria:
- Age less than (\<) 18 years
- HbA1c \<7.0% or greater than (\>) 10% at screening
- Diabetes other than type 2 diabetes mellitus
- Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose
- Any contraindication to use of insulin glargine as defined in the national product label
- Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit
- Use of an insulin pump in the last 6 months before screening visit
- Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit
- History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
- Pregnant or breast-feeding women or women who intend to become pregnant during the study period
- Substudy exclusion criteria:
- Participant not willing to use the adaptable injection intervals on at least two days per week
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
807 Patients enrolled
Trial Details
Trial ID
NCT01499082
Start Date
December 1 2011
End Date
September 1 2013
Last Update
March 25 2022
Active Locations (193)
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1
Investigational Site Number 840156
Chandler, Arizona, United States, 85224
2
Investigational Site Number 840102
Glendale, Arizona, United States, 85306
3
Investigational Site Number 840071
Phoenix, Arizona, United States, 85028
4
Investigational Site Number 840121
Sun City, Arizona, United States, 85351