None listed
Conditions
Interventions
Investigational medicinal product Type of group
Investigational medicinal product
• Formulation: insulin glargine will be supplied as a sterile, non-pyrogenic, clear, colorless
solution in SoloStar® prefilled (disposable) pen for SC injection. SoloStar pen is
necessary for Gla-300 administration and it is considered as integral part of the IMP.
- Each prefilled pen contains a total of 450 units of insulin glargine (1.5 mL of
300 units/mL insulin glargine) solution.
• Route of administration: subcutaneous.
• Time o
Sponsors
Sanofi Aventis Recherche & Development,
Eligibility
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Absolute change in HbA1c Measure:Change in glycated hemoglobin (HbA1c) Timepoints:Baseline to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Absolute change in HbA1c Measure:Change in glycated hemoglobin (HbA1c) Timepoints:Baseline to Week 12 ; Outcome name:Percentage of participants with HbA1c below 7% Measure:Participants with HbA1c below 7% Timepoints:Week 12 and 26 ; Outcome name:Percentage of participants reaching targeted fasting SMPG of 80 to 110 mg/dL (4.4 to 7.2 mmol/L) Measure:Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L) Timepoints:Week 12 and 26 ; Outcome name:Absolute change in fasting SMPG Measure:Change in fasting SMPG Timepoints:Baseline to Week 26 ; Outcome name:Absolute change in SMPG profile Measure:Change in SMPG profile Timepoints:Baseline to Week 26 ; Outcome name:Absolute change in FPG Measure:Change in fasting plasma glucose (FPG) Timepoints:Baseline to Week 26 ; Outcome name:Percentage of participants requiring rescue therapy by additional antidiabetic medication Measure:Patients requiring rescue therapy Timepoints:Baseline to Week 12 and 26 ; Outcome name:Number of participants with at least 1 hypoglycemia event Measure:Hypoglycemia events Timepoints:Baseline to Week 26 ; Outcome name:Number of participants with AEs, serious adverse events (SAEs) (including hypoglycemic episodes associated with seizures, coma, or unconsciousness). Measure:Number of participants with adverse events (AEs) Timepoints:Baseline to Week 27 ; Outcome name:Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire Measure:Treatment satisfaction Timepoints:Baseline to Week 26 ; Outcome name:Number of participants with health care utilization, including hospitalization, emergency room visits, and office [or specialty] visits Measure:Health care utilization Timepoints:Baseline to Week 26 | — |
Countries
Arabia Saudi, Argentina, China, Colombia, Egypt, India, Indonesia, Lebano, Malasya, Peru, Philippines, South Africa, Thailand, Tunisia, Turkey
Contacts
Public ContactShellah Albites
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed