Status:
COMPLETED
Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary Objective: To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current bas...
Detailed Description
Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Participants with type 2 diabetes mellitus.
- Participants on "standard of care" basal insulin therapy administered once or twice daily, as per labeling for at least 6 months prior to screening visit, with or without other antidiabetics approved for using with insulin.
- Glycated hemoglobin (HbA1c) between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.
- Fasting plasma glucose values above 130 mg/dL.
- Exclusion criteria:
- Unstable basal insulin regimen in the last 8 weeks prior to screening visit (ie, type of insulin and time/frequency of the injection, insulin doses \[variation more than ±20%\]).
- Treatment with insulin other than basal insulin: mixed insulin (premixes), rapid insulin, fast acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted).
- 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 :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2020
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT03760991
Start Date
December 18 2018
End Date
September 23 2020
Last Update
April 25 2022
Active Locations (14)
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1
Investigational site Argentina
Buenos Aires, Argentina
2
investigational site COLOMBIA
Colombia, Colombia
3
investigational site Egypt
Egypt, Egypt
4
investigational site HONG KONG
Hong Kong, Hong Kong