A clinical trial to study the effects of two drugs, iGlarLixi versus premixed insulin in patients with type 2 diabetes mellitus whose diabetes condition is uncontrolled with basal insulin and oral anti-diabetic agents.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/03/018075
- Lead Sponsor
- Sanofi Synthelabo India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 887
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 <=10%;
-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%);
-Age <18 years or age < legal age of
majority, whichever is greater, at the
time of screening;
-BMI <20 and >=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 <30 U at screening;
-Type 1 diabetes mellitus or any diabetes other than T2DM;
-Basal insulin dose <20 Units (U) and >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, <=10 days) with other insulin types due to intercurrent illness is permitted at the discretion of the Investigator;
-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/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in HbA1c and weight change in both armsTimepoint: Baseline to week 26
- Secondary Outcome Measures
Name Time Method -Proportion of patients achieving HbA1c target Ë? 7% without weight gain, <br/ ><br> <br/ ><br>-Proportion of patients achieving HbA1c target 7% without weight gain and hypoglycemia (plasma glucose â?¤70 mg/dL). <br/ ><br> <br/ ><br>-Superiority of iGlarLixi versus premix insulin in HbA1c reduction. <br/ ><br>-Proportion of patients achieving HbA1c target 7%. <br/ ><br>-Change in total daily insulin dose. <br/ ><br>-Change in fasting plasma glucose (FPG). <br/ ><br>Timepoint: Week 26 in both arms