Prospective study to assess with Continuous Glucose Monitoring (CGM) the efficacy and safety of switching to insulin glargine 300 U/ml from insulin glargine 100 U/ml in Type 2 Diabetes (T2DM) patients with renal impairment - Renal-TIR

Sanofi-Aventis S.A0 个研究点目标入组 125 人开始时间: 2022年2月11日最近更新: 2022年5月16日

适应症

试验速览

暂无简介。

•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 < 9% within 3 months prior to enrollment
•BMI between 25 and 40 kg/m2
•Ability and willingness to wear the Freestyle IQ Pro as required by the protocol
•Signed informed consent form
•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 62
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 63

•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

发起方

Sanofi-Aventis S.A