Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorCelltrion
About this trial
Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults at the time of signing the Informed Consent Form (ICF)
Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study
Diagnosed with T2DM
Disqualifiers
Diagnosed with other types of diabetes than T2DM
History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy
Uncontrolled severe complications of diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin
Drugtablets, QD, oral administration
Alogliptin
Drugtablets, QD, oral administration
empagliflozin
Drugtablets, QD, oral administration
Treatment groups
171 Participants
are divided into 3 treatment groupsGroup A: Study group 1Active comparator 3 interventions
Group B: Study group 2Active comparator 3 interventions
Group C: Control GroupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
HbA1c
Change from Baseline in HbA1c
Time frame
Week 24 of the Treatment Source ClinicalTrials.gov