Uncontrolled Type 2 Diabetes Mellitus MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each participant must meet all of the following criteria to be enrolled in this study: 1.Is capable of understanding the written informed consent, provides signed written informed consent, is willing and able to complete the electronic diary (eDiary), and agrees to comply with protocol requirements. 2.Is an adult =18 years of age. 3.Was diagnosed with T2DM at least 6 months before the screening visit. 4.Has a body mass index (BMI) =20 and 130 mg/dL confirmed by the central laboratory at the screening visit. 7.Has been on premixed insulin therapy (for =3 months and 12units/day and =65 years) yes F.1.3.1 Number of subjects for this age range 79
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 1.Has been diagnosed with type 1 diabetes mellitus (T1DM). 2.Has a history of severe hypoglycemia within 6 months before the screening visit or a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms or as the failure to sense a significant fall in blood glucose below normal levels). 3.Has been using OADs other than allowed in the inclusion criterion or metformin plus =2 OADs within the 3 months before the screening visit. 4.Has a history of discontinuation of a previous treatment with GLP-1 RA due to safety/tolerability reasons or lack of efficacy. 5.Has used weight loss drugs (over-the-counter [OTC] or herbal medications) within 3 months before the screening visit or has a history of bariatric surgery. 6.Has any clinically significant abnormality identified on physical examination, vital sign measurements, or laboratory tests (eg, amylase, lipase, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 × upper limit of normal [ULN], calcitonin =20 pg/mL) that, in the opinion of the investigator or any qualified designee, would make implementation of the protocol or interpretation of the study results difficult or would preclude safe participation in the study. 7.Is currently hospitalized (except hospitalization for routine diabetes checkup). 8.Has a history of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, or pancreatectomy. 9.Has severe hypertriglyceridemia (>500 mg/dL). 10.Has clinically relevant history of GI disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis or a history of surgery affecting gastric emptying. 11.Has a history of metabolic acidosis, including diabetic ketoacidosis, within 1 year before the screening visit. 12.Has severe renal impairment or end-stage renal disease, as defined by estimated glomerular filtration rate of <30 mL/min/1.73 m2. 13.Has personal or immediate family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes the participant to MTC (eg, multiple endocrine neoplasia syndromes). 14.Has received systemic glucocorticoid therapy (excluding topical, intra-articular, or ophthalmic application, nasal spray or inhaled forms) for =10 consecutive days in the last 3 months before the screening visit. 15.Has current or known history of alcohol or drug abuse within 6 months before the screening visit. 16.Has known presence of factors that interfere with HbA1c measurement (eg, specific hemoglobin variants, hemolytic anemia) that compromises the reliability of HbA1c assessment or has a medical condition that affects interpretation of HbA1c results (eg, blood transfusion or severe blood loss in the last 3 months before the screening visit, any condition that shortens erythrocyte survival). 17.Has contraindications to iGlarLixi in accordance with local label or warning/precaution of use (when appropriate), as displayed in the respective National Product Labeling. 18.Is subject to any country-related specific regulation that would prevent the participant from entering the study. 19.Has been exposed to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is longer, before the screening visit. 20.I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe glycemic control, as measured by HbA1c, in people with T2DM switching from premixed insulins to iGlarLixi using an algorithm based on doses of both insulin components (basal plus mealtime);Secondary Objective: Secondary Objectives: 1)To establish further clinical benefit of switching from premixed insulins to iGlarLixi, in terms of efficacy. 2)To establish the safety of switching from premixed insulins to iGlarLixi. ;Primary end point(s): Change in HbA1c from baseline to Week 24.;Timepoint(s) of evaluation of this end point: Baseline, Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Percentage of participants achieving a HbA1c target of 0 at Week 24. 9)Hypoglycemia rates during 24 weeks of treatment 9.1)Percentage of participants with at least 1 hypoglycemia event 9.2)Number of events per participant-year 10)Number of participants with AEs and SAEs, including AESIs.;Timepoint(s) of evaluation of this end point: Time points for evaluation provided below for corresponding secondary endpoints as numbered in E.5.2 above: 1) Baseline, Week 24 2) Baseline, Week 24 3) Baseline, Week 24 4) Baseline, Week 24 5) Baseline, Week 24 6) Baseline, Week 24 7) Baseline, Week 24 8) Week 24 9.1)Baseline up to Week 24 9.2) Baseline up to Week 24 10) Baseline up to Week 24 | — |
Countries
Czechia, Czech Republic, Korea, Republic of, Poland, Turkey
Contacts
Public ContactProject Management
PPD Global
Outcome results
None listed