Patients with Type 2 Diabetes who have failed to achieve glycemic control with basal insulin and oral antidiabetic agents(OADs) MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Suliqua
Product Name: iGlarLixi (SoloStar) 100 U/mL + 50 µg/mL
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
C
Sponsors
Sanofi-Aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: -Age 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: -in terms of glycemic control parameters(HbA1c target <7%) and weight -in terms of glycemic control parameters weight and hypoglycemia -in terms of superiority of iGlarLixi on glycemic control parameters -To assess safety and tolerability in each treatment group ;Primary end point(s): 1. Change in Glycated hemoglobin (HbA1c) 2. Change in weight;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 26 2. Baseline to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 3. Superiority in HbA1c reduction: Change from baseline in HbA1c to Week 26 4. Hypoglycemia at = 70 mg/dL (3.9 mmol/L): Number of patients with documented hypoglycemia at = 70 mg/dL (3.9 mmol/L) 5. Hypoglycemia at <54 mg/dL (<3.0 mmol/L): Number of patients with documented hypoglycemia at <54 mg/dL (<3.0 mmol/L) 6. Severe hypoglycemia: Number of patients with severe hypoglycemia defined as severe cognitive impairment requiring external assistance for recovery;Timepoint(s) of evaluation of this end point: 1. Week 26 2. Week 26 3. Baseline to week 26 4. Baseline to week 26 5. Baseline to week 26 6. Baseline to week 26 | — |
Countries
Algeria, Argentina, Austria, Bulgaria, Czech Republic, Greece, India, Korea, Republic of, Kuwait, Macedonia, the former Yugoslav Republic of, Mexico, Romania, Saudi Arabia, Serbia, Spain, Sweden, Taiwan, Turkey, United Arab Emirates
Contacts
Public Contactwww.sanofi.cz
sanofi-aventis, s.r.o.
Outcome results
None listed