Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin, Alogliptin, empagliflozin.
- Who it may be relevant to
- Registry conditions: T2DM, Diabete Type 2, DM. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin
Overview
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.
Interventions
- Drug Metformin
tablets, QD, oral administration - Drug Alogliptin
tablets, QD, oral administration - Drug empagliflozin
tablets, QD, oral administration
Primary outcome measures
- HbA1c [Time frame: Week 24 of the Treatment]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Celltrion — Seoul
Identifiers
NCT: NCT07093476 · CT-L02-301