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

Not Applicable

• Conditions: -E10 Insulin-dependent diabetes mellitus; Insulin-dependent diabetes mellitus; E10

• Registration Number: PER-009-19
• Lead Sponsor: Sanofi Aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-26
• Study Completion: 2020-09-09
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

Age
I 01. Participants must be >18 years of age (inclusive), at the time of signing the informed
consent.
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, 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.
Sex
I 06. Male or Female
- Female participants: A female participant is eligible to participate if she is not pregnant
(see Appendix 4 [Section 10.4]), not breastfeeding, and at least 1 of the following
conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 4
(Section 10.4).
OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 4
(Section 10.4) during the intervention period and for at least 1 week after the last dose
of study intervention (ie, until Week 27).
Informed Consent
I 07. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1.3)
which includes compliance with the requirements and restrictions listed in the informed
consent form (ICF) and in this protocol.

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,
and 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).
E 07. Use of non-insulin antidiabetic drugs other than those listed in inclusion criteria.
E 08. Change in existing dose or initiation of new, non-insulin antidiabetic drugs in the 8 weeks
prior to screening visit.
E 09. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for
2 weeks or more within 8 weeks prior to screening visit.
E 10. Likelihood to require treatment prohibited by the protocol during the study.
Prior/concurrent clinical study experience
E 11. Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is
longer, prior to screening visit or concomitant enrollment in any other clinical study
involving an investigational study treatment.
Diagnostic Assessments
Not applicable
Other exclusions
E 12. Any specific situation during study implementation/course that may raise ethics
considerations.
E 13. History of hypoglycemia unawareness.
E 14. Known hypersensitivity/intolerance to Gla-300 or any IMP excipients.
E 15. History of drug or alcohol abuse within 6 months prior to screening visit.
Additional criteria at the end of the screening period
E 16. Participants unwilling or unable to comply with study procedures as outlined in the
protocol.
E 17. Participants who withdraw consent during the screening (starting from signed ICF).

Study & Design

• Study Type: Interventional
• Study Design: Not specified