Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: iGlarLixi: 100 U/mL + 50 μg/mL pre-filled pen with a fixed ration of 2 U insulin glargine and 1μg lixisenatide once daily dosing.
The total duration of such therapy for each arm is â
Sponsors
Sanofi Synthelabo India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: - Signed written informed consent. - Patients with T2DM diagnosed for at least 1 year at the time of screening; - Uncontrolled diabetes as demonstrated by a screening centrally measured HbA1c >=7.5% and - Patients who have been treated with any basal insulin combined to 1 or 2 OADs that could be metformin alone or metformin + SGLT-2 inhibitor on stable dose for the last 3 months prior to screening (stable basal insulin therapy defined as maximum change in insulin dose of ±20%);
Exclusion criteria
Exclusion criteria: - Age majority, whichever is greater, at the time of screening; - BMI =40 kg/m2; - Fasting plasma glucose (FPG) level >200 mg/dL (11.1 mmol/L) at screening visit via central lab test and confirmed ( >200 mg/dL [11.1 mmol/L]) by a repeated test before randomization for patients with basal insulin - Type 1 diabetes mellitus or any diabetes other than T2DM; - Basal insulin dose 50 U at screening; - Use of any antidiabetic agent other than basal insulin, metformin or SGLT-2i in the 3 months prior to the screening visit. Note: History of short-term treatment (ie, - Use of weight loss drugs (including over-the-counter and herbal medications) within 12 weeks prior to the screening visit; - Any clinically significant abnormality identified on physical examination or vital signs or laboratory tests (such as amylase and/or lipase: >3 times the upper limit of the normal) at the time of screening, or any condition (including but not limited to acute pancreatitis, severe gastroparesis, severe renal impairment, or end-stage renal disease) that in the opinion of the Investigator or any Sub investigator would make implementation of the protocol or interpretation of the study results difficult or would preclude the safe participation of the patient in this protocol; - Patients with conditions/concomitant diseases making them non-evaluable for the 2 primary endpoints (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within the last 3 months prior to the screening visit); - Known history of drug or alcohol abuse within 6 months prior to the screening visit; - Any technical/administrative reason (eg, patient homeless)that makes it impossible to randomize the patient in the study; - Patient who has taken other investigational drugs within 1 months or 5 half-lives from screening, whichever is longer; - Patient not suitable for participation, whatever the reason,as judged by the Investigator, or patients potentially at risk of noncompliance to the study procedures (eg, not willing and/or not able to perform self-monitoring of plasma glucose [SMPG], or to follow health care providerâ??s instructions on titration protocol); - Any contraindication to the use of premixed insulin, metformin, or SGLT2i for those who used it prior to the study, in accordance with local label or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling; - Any contraindication to the use of iGlarLixi in accordance with local label or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling; - Hypersensitivity to the active substance or to any of the excipients; - Pregnant or breast-feeding women; - Women of childbearing potential (WOCBP) not protected by highly effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. Pregnancy tests may be performed more frequently in some countries due to local legislations related to WOCBP randomized in clinical trials; <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in HbA1c and weight change in both armsTimepoint: Baseline to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients achieving HbA1c target Ë? 7% without weight gain, - Proportion of patients achieving HbA1c target 7% without weight gain and hypoglycemia (plasma glucose â?¤70 mg/dL). - Superiority of iGlarLixi versus premix insulin in HbA1c reduction. - Proportion of patients achieving HbA1c target 7%. - Change in total daily insulin dose. - Change in fasting plasma glucose (FPG). Timepoint: Week 26 in both arms | — |
Countries
Algeria, Argentina, Austria, Bulgaria, Czech Republic, Greece, India, Kuwait, Mexico, Republic of Korea, Romania, Saudi Arabia, Serbia, Spain, Sweden, Taiwan, The former Yugoslav Republic of Macedonia, Turkey, United Arab Emirates
Contacts
Public ContactShraddha Bhatia
Sanofi Synthelabo India Private Limited
Outcome results
None listed