LBCTR2019040212
Other
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 - ARTEMIS-DM
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Patients with Type 2 diabetes mellitus uncontrolled on basal insulin
- Sponsor
- Sanofi
- Enrollment
- 11
- Status
- Other
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Protocol: Page 26\-27
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •I 01\. Participants must be \>18 years of age (inclusive), at the time of signing the informed
- •\-Type of participant and disease characteristics
- •I 02\. Participants with T2DM.
- •I 03\. Participants on standard of care” 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, a\-glucosidase inhibitor) and
- •with or without use of a GLP\-1 receptor agonist, approved for using with insulin.
Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria apply:
- •\-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
Outcomes
Primary Outcomes
Not specified
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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 INSULI-E10 Insulin-dependent diabetes mellitusInsulin-dependent diabetes mellitusE10PER-009-19Sanofi Aventis Recherche & Development,26
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