Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Premixed Insulin on Top of Metformin in Patients With Type 2 Diabetes and ± Sodium-glucose Cotransporter 2 Inhibitors (SGLT2i)

Phase 1

Conditions: Patients with Type 2 Diabetes who have failed to achieve glycemic control with basal insulin and oral antidiabetic agents(OADs)
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: EUCTR2017-003370-13-GR

Lead Sponsor: Sanofi-Aventis Groupe

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1124

Inclusion Criteria

-Patients with Type 2 dibetes mellitus (T2DM) diagnosed for at least 1 year at the time of screening.
-Uncontrolled diabetes as demonstrated by a screening centrally measured glycated hemoglobin (HbA1c) =7.5% and =10%.
-Patients who have been treated with any basal insulin combined to 1 or 2 Oral Antidibetic Drug (OADs) that could be metformin alone or metformin with or without sodium -glucose cotransporter 2 inhibitors (SGLT2i) on stable dose for the last 3 months prior to screening (stable basal insulin therapy defined as maximum change in insulin dose of ±20%).
-Signed written informed consent.
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 899
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

-Age <18 years or age < legal age of majority, whichever is greater, at the time of screening.
- Body mass index (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 (i.e., =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 contraindication to the use of iGlarLixi, premixed insulin, metformin, or SGLT2i for those who used it prior to the study, in accordance with local label.
-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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that in patients with Type 2 diabetes melitus(T2DM) failing to achieve control on their current basal insulin combined with one or 2 Oral Antidiabetic Drug (OADs), iGlarLixi compared to premixed insulin showed non inferiority of iGlarLixi in terms of Glycated hemoglobin (HbA1c) reduction or superiority on body weight change. ;Secondary Objective: -To compare in T2DM patients failing to achieve control on their current basal insulin containing regimen combined to 1 or 2 OADs between treatment arms: <br> -in terms of glycemic control parameters(HbA1c target <7%) and weight <br> -in terms of glycemic control parameters weight and hypoglycemia <br> -in terms of superiority of iGlarLixi on glycemic control parameters <br>-To assess safety and tolerability in each treatment group <br>;Primary end point(s): 1. Change in Glycated hemoglobin (HbA1c)<br>2. Change in weight;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 26<br>2. Baseline to Week 26

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. Week 26<br>2. Week 26<br>3. Baseline to week 26<br>4. Baseline to week 26<br>5. Baseline to week 26<br>6. Baseline to week 26;Secondary end point(s): 1. Patients with HbA1c target <7% without weight gain: Number of patients with HbA1c target <7% without weight gain at Week 26<br>2. Patients with HbA1c target <7% without hypoglycemia and without weight gain: Number of patients with HbA1c target <7% without hypoglycemia and without weight gain at Week 26<br>3. Superiority in HbA1c reduction: Change from baseline in HbA1c to Week 26<br>4. Hypoglycemia at = 70 mg/dL (3.9 mmol/L): Number of patients with documented hypoglycemia at = 70 mg/dL (3.9 mmol/L) <br>5. Hypoglycemia at <54 mg/dL (<3.0 mmol/L): Number of patients with documented hypoglycemia at <54 mg/dL (<3.0 mmol/L)<br>6. Severe hypoglycemia: Number of patients with severe hypoglycemia defined as severe cognitive impairment requiring external assistance for recovery

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