Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Insulin glargine 300 U/mL / Gla-300/ Toujeo: Dose formulation- prefilled (disposable) pen
Unit dose strength(s) - Each prefilled pen contains a total of 450 units of insulin glargine (1
Sponsors
Sanofi India Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Age I 01. Participant 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 type 2 diabetes mellitus. I 03. Participants who are insulin na�¯ve on at least one oral antihyperglycemic drug (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, �±-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for a minimum period of 6 months prior to screening. The background non-insulin antidiabetic drug should be administered at stable dose for at least 8 weeks prior to screening Sex I 04. 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). OR 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 (i.e., until Week 27). Informed Consent I 05. Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Other criteria I 06. HbA1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening. I 07. Median of the last 3 consecutive fasting self-monitored blood glucose (SMBG)values prior to baseline, or at least 2 fasting SMBG values in the week prior to baseline >130 mg/dL.
Exclusion criteria
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 (e.g., 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. History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit. E 03. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator Prior/concomitant therapy E 04. Treatment with any insulin including 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 05. Use of non-insulin anti-hyperglycemic drugs other than those listed in inclusion criteria. E 06. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit. E 07. Likelihood to require treatment prohibited by the protocol during the study Prior/concurrent clinical study experience E 08. 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. Other exclusions E 09. Any specific situation during study implementation/course that may raise ethics considerations. E 10. History of hypoglycemia unawareness. E 11. Hypersensitive to insulin glargine or any of the excipients E 12. History of drug or alcohol abuse within 6 months prior to screening visit. Additional criteria at the end of the screening period E 13. Participants unwilling or unable to comply with study procedures as outlined in the protocol E 14. Participants who withdraw consent during the screening (starting from signed ICF).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective: To evaluate the safety of Gla-300 in insulin naÃ?¯ve T2D participants uncontrolled on oral antihyperglycemic Drugs End point: Percentage of participants with Treatment Emergent Adverse Events (TEAEs) including serious adverse events (SAEs) and hypoglycemic episodes Timepoint: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| End point: Percentage of participants with at least 1 confirmed (Level 1) hypoglycemia event from baseline to Week 24. Change in HbA1c from baseline to Week 12 and 24 Percentage of participants reaching general HbA1c target of 7% at Weeks 12 and 24. Percentage of participants reaching targeted fasting selfmonitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L) at Weeks 12 and 24 Change in fasting plasma glucose (FPG) from baseline to Week 24.Timepoint: Week 24;Objective: To assess the efficacy of Gla-300 on glycemic control in insulin naÃ?¯ve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in participantââ?¬â?¢s treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire) Timepoint: Week 24 | — |
Countries
India
Contacts
Public ContactDr Vishal Patil
Sanofi Healthcare India Private Limited
Outcome results
None listed