CTRI/2019/08/020701
Not yet recruiting
Phase 4
A multicenter, multinational, prospective, interventional, single-arm, Phase IV study evaluating the clinical efficacy and safety of 26 weeks of treatment with insulin glargine 300 U/mL (Gla-300) in patients with Type 2 diabetes mellitus uncontrolled on basal insulin
SanofiAventis Groupe0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Sponsor
- SanofiAventis Groupe
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type of participant and disease characteristics
- •I 02\. Participants with T2DM.
- •I 03\. Participants on â??standard of careâ?? basal insulin therapy (including Gla\-100, detemir, degludec, NPH insulin), administered once or twice daily, as per labeling for at least 6 months prior to screening visit, with or without oral agents (metformin, sulfonylurea, thiazolidinedione, DPP\-4 inhibitor, SGLT\-2 inhibitor, glinide, α\-glucosidase inhibitor) and with or without use of a GLP\-1 receptor agonist, approved for using with insulin.
- •I 04\. HbA1c between 7\.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.
- •I 05\. Median of the last 3 consecutive fasting SMPG values prior to baseline, or at least 2 fasting SMPG values in the week prior to baseline \>130 mg/dL
- •I 06\. Male or Female
- •\- Female participants: A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least 1 of the following
- •conditions applies:
- •\- Not a woman of childbearing potential (WOCBP)
- •\- A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 1 week after the last dose of study intervention (ie, until Week 27\).
Exclusion Criteria
- •Medical conditions
- •E 01\. Any clinically significant abnormality identified either in medical history or during screening evaluation (eg, physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period which in judgment of the Investigator would preclude safe completion of the study or constrains efficacy assessment.
- •E 02\. Known presence of factors that interfere with the HbA1c measurement (eg, specific hemoglobin variants, hemolytic anemia) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (eg, blood transfusion or severe blood loss in the last 3 months prior to baseline, any condition that shortens erythrocyte survival).
- •E 03\. History of severe hypoglycemia requiring emergency room admission or hospitalization
- •within 3 months prior to screening visit.
- •E 04\. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator.
- •Prior/concomitant therapy
- •E 05\. 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%]).
- •E 06\. Treatment with insulin other than basal insulin: mixed insulin (premixes), rapid insulin,
Outcomes
Primary Outcomes
Not specified
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