Clinical trial • Phase IV • Endocrinology|Other

SOTAGLIFLOZIN for Type 1 diabetes mellitus|Chronic kidney disease (CKD) with albuminuria

Phase IV trial of SOTAGLIFLOZIN for Type 1 diabetes mellitus|Chronic kidney disease (CKD) with albuminuria.

Overview

Trial Therapeutic Area
Endocrinology|Other
Trial Disease
Type 1 diabetes mellitus|Chronic kidney disease (CKD) with albuminuria
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-05-2024
First CTIS Authorization Date
08-08-2024

Trial design

SOTAGLIFLOZIN (oral film-coated tablet, product listed with max daily dose 200 mg) and PLACEBO PRODUCT [PLACEBO MATCHING SOTAGLIFLOZIN 200 MG FILM-COATED TABLETS]; schedule/dosing regimen not specified in provided data.-controlled Phase IV trial across 1 site in Denmark.

Comparator
SOTAGLIFLOZIN (oral film-coated tablet, product listed with max daily dose 200 mg) and PLACEBO PRODUCT [PLACEBO MATCHING SOTAGLIFLOZIN 200 MG FILM-COATED TABLETS]; schedule/dosing regimen not specified in provided data.
Target Sample Size
39
Trial Duration For Participant
84

Eligibility

Recruits 39 No vulnerable population selected in CTIS; no consent/assent handling for vulnerable participants is described..

Vulnerable Population
No vulnerable population selected in CTIS; no consent/assent handling for vulnerable participants is described.

Inclusion criteria

  • {"criterion_text":"- Adults with type 1 diabetes mellitus"}
  • {"criterion_text":"- Chronic Kidney Disease and albuminuria"}

Exclusion criteria

  • {"criterion_text":"- Non-diabetic Kidney Disease"}
  • {"criterion_text":"- eGFR<25mL/min/1.73m^2, dialysis or kidney transplantation"}
  • {"criterion_text":"- Previous diabetic ketoacidosis, except at debut"}
  • {"criterion_text":"- Receiving therapy with an SGLT inhibitor within 8 weeks prior to enrolment or previous intolerence of an SGLT inhibitor."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from 0 to 12 weeks in dynamic R2*-weighted signal (BOLD) as an indirect measure of renal blood oxygenation after treatment with sotagliflozin compared with placebo.","definition_or_measurement_approach":"Change from baseline (0) to 12 weeks in dynamic R2*-weighted BOLD MRI signal as an indirect measure of renal blood oxygenation; comparison between sotagliflozin and placebo."}

Recruitment

Planned Sample Size
39
Recruitment Window Months
64

Geography

Total Number Of Sites
1
Total Number Of Participants
39

Denmark

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
455
Number Of Sites
1
Number Of Participants
39

Sites

Site Name
Steno Diabetes Center Copenhagen
Department Name
Clinical and Translational Research, Complications Research
Principal Investigator Name
Peter Rossing
Principal Investigator Email
peter.rossing@regionh.dk
Contact Person Name
Peter Rossing
Contact Person Email
peter.rossing@regionh.dk
Number Of Participants
39

Sponsor

Primary sponsor

Full Name
Steno Diabetes Center Copenhagen
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"","full_name":"JDRF","duties_or_roles":"Source of monetary support","organisation_type":""}
  • {"country":"","full_name":"Lexicon Pharmaceuticals, Inc.","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
SOTAGLIFLOZIN
Active Substance
SOTAGLIFLOZIN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
200 mg per day
Investigational Product Name
PLACEBO PRODUCT [PLACEBO MATCHING SOTAGLIFLOZIN 200 MG FILM-COATED TABLETS]
Modality
Other

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