Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus
ConditionType 2 Diabetes Mellitus
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEMS
About this trial
The purpose of this study is to evaluate the efficacy and safety of LID104 in the treatment of type 2 diabetes mellitus.
Eligibility criteria
Qualifiers
Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;
Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise and monotherapy with the maximum tolerated dose of metformin at a stable dose in the last 3 months and which, in the Investigator's discretion, may benefit from the addition of the trial drugs.
Participants with HbA1c ≥ 7.5% and ≤ 10.5% at the screening visit.
Participants with body mass index ≤ 45 kg/m2
Disqualifiers
Any clinical observation or laboratory condition finding that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s);
History of alcohol and/or illicit drug use disorder in the last two years;
Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using reliable contraception;
Participants with known allergy or hypersensitivity to the components of the drugs used during the clinical trial;
Trial design
Treatments tested in this trial
- LID104
- Dapagliflozin
- Linagliptin
Treatment groups
597 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov