A Study to Evaluate the Efficacy and Safety of Switching to iGlarLixi in People with Type 2 Diabetes Mellitus Uncontrolled on Once or Twice Daily Premixed Insulin Regime

Phase 1

Conditions: ncontrolled Type 2 Diabetes Mellitus
MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2021-003711-25-PL

Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 168

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 <40 kg/m² during screening.*
*Body weight and height will be recorded during screening for the calculation of BMI (metric: BMI = weight (kg)/height [m2]).
5.Has an HbA1c =7.5% and =10.0% during screening.
6.Has fasting plasma glucose (FPG) values before baseline =130 mg/dL confirmed by the central laboratory at the screening visit.
7.Has been on premixed insulin therapy (for =3 months and <10 years of total duration),* with or without OADs that has to be metformin alone or (metformin, plus sodium-glucose co-transporter-2 (SGLT2) inhibitor or DPP-4i, or SU, all of them , with stable doses for 3 months before the screening visit.
*Allowed premixed combinations include insulin aspart (30%) + insulin aspart protamine (70%); insulin lispro (25%) + insulin lispro protamine (75%); human insulin isophane suspension (70%) and human insulin injection (recombinant DNA origin, 30%); human insulin isophane
suspension (75%) and human insulin injection (recombinant DNA origin,
25%) of >12 units/day and <50 units/day.
8.If female, is not pregnant or breastfeeding and one of the following conditions applies:
8.1) Is a woman of non-childbearing potential (WONCBP), as defined in contraceptive and barrier guidance.
8.2) Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of <1%, as described in contraceptive and barrier guidance during the study treatment period (to be effective before starting the intervention) and for at least 1 week after the last administration of study drug.
A WOCBP must have a negative urine pregnancy test at the screening visit.
(Note: If a urine test cannot be confirmed as negative [eg, an ambiguous result], a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.)
9. For participants on daily DPP-4i, willingness to discontinue DPP-4i before switching to iGlarLixi.
10. For participants on SU, willingness to discontinue SU before switching to iGlarLixi.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 146
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79

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.Is

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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