Toujeo in Type 2 Diabetes patients with renal impairment

Phase 1

• Conditions: Type 2 Diabetes Mellitus; 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: EUCTR2021-005353-82-ES
• Lead Sponsor: Sanofi-Aventis S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-11
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 125

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 < 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified