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
Interventions
Trade Name: Toujeo® 300 U/ml (solución inyectable)
Product Name: Insulina glargina
Product Code: HOE901 - U300
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULI
Sponsors
Sanofi-Aventis S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosed with Type 2 Diabetes Mellitus = 3 years prior to study enrolment Participants currently treated with Gla-100 for at least 4 months prior to enrollment with or without oral antidiabetics Estimated Glomerular filtration Rate (eGFR) between 30-60 ml/min HbA1c = 7.5 y =65 years) yes F.1.3.1 Number of subjects for this age range 63
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Pregnant or lactating women Participants who have been hospitalized for more than 7 days during screening period Presence of disease / treatment, which in the opinion of the investigator, affects the control of diabetes (e.g., chemotherapy, immunosuppressants, systemic corticosteroids) Participants enrolled during the study period in another clinical study Participants with basal-bolus regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of switching treatment with insulin glargine 100U/ml (Gla-100) to Insulin glargine 300U/ml (Gla-300) using CGM in patients with T2DM and renal impairment;Secondary Objective: • To determine glucose variability and glycemic control with CGM • To assess tolerability and safety profile • To assess patient satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQc) questionnaire;Primary end point(s): Change from baseline to Month 5 in the percentage of Time in Range (TIR);Timepoint(s) of evaluation of this end point: From baseline to Month 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean glucose profile over 24 hours - % Coefficient of variation - % Time below target glucose Range (TBR) - % Time above target glucose Range (TAR) - Change from baseline to Month 5 in HbA1c - Change from baseline to Month 5 in Fasting Plasma Glucose (FPG) - Number of participants with at least one hypoglycemia event - Change from baseline to Month 5 in DTSQc - Number of participants with adverse events;Timepoint(s) of evaluation of this end point: Baseline to Month 5 | — |
Countries
Spain
Contacts
Public ContactUnidad de Estudios Clínicos
Sanofi-Aventis, S.A
Outcome results
None listed