Patients with Type 2 diabetes mellitus uncontrolled on basal insulin Diabetes
Conditions
Interventions
? - Study intervention name: Insulin glargin
Dosage formulation: Gla-300 will be supplied as a sterile, non-pyrogenic, clear, colorless solution in SoloStar® prefilled (disposable) pen for SC injec
? Insulin glargine 300 UI/ml
blood glucose meter (Accu-Chek Performa®) supplied by the sponsor at visit 1 and patient will be instructed in its use
basal insulin
glucosemeter
Sponsors
Sanofi
CRO: IQVIA
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Protocol: Page 26-27 Participants are eligible to be included in the study only if all of the following criteria apply: - 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, a-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 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: 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 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 |
|---|---|
| Name: HbA1c ;Timepoints: baseline to Week 26;Measure: Change in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: effects of Gla-300 on glycemic control: HbA1c ;Timepoints: baseline to Week 12;Measure: Change in HbA1c ;Name: effects of Gla-300 on glycemic control: HbA1c<7%;Timepoints: at Weeks 12 and 26.;Measure: Percentage of participants;Name: effects of Gla-300 on glycemic control:self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL;Timepoints: at Weeks 12 and 26;Measure: Percentage of participants;Name: effects of Gla-300 on glycemic control: fasting plasma glucose (FPG);Timepoints: baseline to Week 26;Measure: Change in fasting plasma glucose;Name: effects of Gla-300 on glycemic control: fasting SMPG;Timepoints: baseline to Week 26.;Measure: Change in fasting SMPG;Name: effects of Gla-300 on glycemic control: 7-point SMPG profile;Timepoints: baseline to Week 26;Measure: Change from baseline to Week 26;Name: effects of Gla-300 on glycemic control: Rescue therapy;Timepoints: by Weeks 12 and 26;Measure: Percentage of participants;Name: Safety Gla -300:at least 1 hypoglycemia;Timepoints: from baseline to Week 26.;Measure: Number of participants;Name: Safety Gla-300: adverse events (AEs) and serious adverse events (SAEs) ;Timepoints: from baseline to Week 26.;Measure: Number of participants;Name: effects of Gla-300 on treatment satisfaction;Timepoints: from baseline to Week 26.;Measure: Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire (ITSQ) ;Name: effects of Gla-300 on healthcare resource;Timepoints: from baseline to Week 26;Measure: Number of participants with HCRU (hospitalization, | — |
Countries
Colombia, Egypt, India, Indonesia, Lebanon, Peru, South Africa
Contacts
Public ContactHusam Ghusn
Ain Wazein village Hospital
Outcome results
None listed