Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LID104

    Drug

    Experimental

  • Dapagliflozin

    Drug

    Active comparator

  • Linagliptin

    Drug

    Active comparator

Treatment groups

597 Participants
are divided into 3 treatment groups
Group A: LID104Experimental treatment 1 intervention
Group B: DapagliflozinActive comparator 1 intervention
Group C: LinagliptinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glycated hemoglobin (HbA1c)

Change from baseline in glycated hemoglobin

Time frame
120 days

Secondary outcomes

1

Fasting blood glucose

Change from baseline in fasting blood glucose

Time frame
120 days
2

HbA1c reduction to < 7%

Proportion of participants with HbA1c reduction to \< 7%

Time frame
120 days
3

Treatment failure

Proportion of participants who were discontinued from the study because they needed medication other than the study medication for blood glucose control

Time frame
Up to 140 days
4

Body weight

Change from baseline in body weight

Time frame
Up to 140 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: