Type 2 Diabetes Mellitus and Renal Impairment MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: TOUJEO®
Product Name: insulin glargine
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Insulin glargine
CAS Number: 160337-95-1
Concentration unit: U/ml
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each patient must meet all of the following criteria to be enrolled in this trial: 1. Is an adult aged =18 years at screening. 2. Was diagnosed with T2DM of >1-year duration and had glycemic levels above target with OADs with or without GLP-1 RA (oral or injectable) at stable doses for =3 months before the screening period. 3. Has an HbA1c =7.5% and =10.5% at screening. 4. Has renal impairment, as defined by an eGFR of =65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the trial: 1. Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA. 2. Has a body mass index (BMI)* >45 kg/m² during the screening period. *Body weight and height will be recorded during the screening period for the calculation of BMI (BMI = weight [kg]/[height (m)]2). 3. Has a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms [eg, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion] or as the failure to sense a significant fall in blood glucose below normal levels). 4. Has a history of 2 or more episodes of severe hypoglycemia and/or 2 or more episodes of diabetic ketoacidosis within the 6 months before the day of screening. 5. Has been exposed to other investigational drug(s) within 1 month or 5 half-lives from screening, whichever is longer. Specific to the CGM Substudy 6. Uses substances known to interfere with CGM readings, such as aspirin-containing products (>650 mg/day of acetylsalicylic acid) or supplements containing vitamin C (>1000 mg/day of ascorbic acid) taken during the 14-day periods of baseline CGM assessment (ie, from Week –2 to Week 0) and the treatment period (ie, from Week 12 to Week 14 and from Week 22 to Week 24).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority (with a margin of 0.3%) and, if achieved, to demonstrate the superiority in the efficacy of Gla-300 compared with IDeg-100 in terms of change in HbA1c from baseline to Week 24 in insulin-naïve patients with T2DM and renal impairment who have glycemic levels above target with oral antidiabetic drugs (OADs) with or without glucagon-like peptide 1 receptor agonist (GLP-1 RA);Secondary Objective: To evaluate the effects of treatment with Gla-300 compared with IDeg-100 on clinical parameters.;Primary end point(s): HbA1c: Change from baseline to Week 24 (Gla-300 vs IDeg-100);Timepoint(s) of evaluation of this end point: from baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Fasting plasma glucose (FPG): Change from baseline to Week 24 • Fasting SMPG: Change from baseline to Week 24 • 7-point SMPG profiles: Change from baseline to Week 24, per time point within 24-hour period • Percentage (%) of patients reaching HbA1c target of <7.0% at Week 24;Timepoint(s) of evaluation of this end point: from baseline to Week 24 | — |
Countries
Czechia, Hungary, Poland, Serbia, United States
Contacts
Public ContactProject Lead
PPD
Outcome results
None listed