Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus

NCT05886088 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: LID104-III-0123
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of LID104 in the treatment of type 2 diabetes mellitus.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (HbA1c)

  Change from baseline in glycated hemoglobin

  120 days

Secondary Outcomes (5)

• Fasting blood glucose

  120 days

• HbA1c reduction to < 7%

  120 days

• Treatment failure

  Up to 140 days

• Body weight

  Up to 140 days

• Blood pressure

  Up to 140 days

Study Arms (3)

LID104

EXPERIMENTAL

The patient must take 1 tablet of LID104 plus 1 tablet of placebo of dapagliflozin and 1 tablet of placebo of linagliptin once a day.

Drug: LID104

Dapagliflozin

ACTIVE COMPARATOR

The patient must take 1 tablet of dapagliflozin plus 1 tablet of placebo of LID104 and 1 tablet of placebo of linagliptin once a day.

Drug: Dapagliflozin

Linagliptin

ACTIVE COMPARATOR

The patient must take 1 tablet of linagliptin plus 1 tablet of placebo of LID104 and 1 tablet of placebo of dapagliflozin once a day.

Drug: Linagliptin

Interventions

LID104 DRUG

Experimental

LID104

Dapagliflozin DRUG

Active comparator

Dapagliflozin

Linagliptin DRUG

Active comparator

Linagliptin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Participants with a current medical history of cancer and/or treatment for cancer in the last five years;
• Participation in a clinical trial protocols in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit at the same;
• Type 1 Diabetes Mellitus;
• Fasting glucose above 300 mg/dL;
• Participants who have risk factors for severe volume depletion;
• Participants on dialysis;
• History of metabolic acidosis and/or using medications that may cause lactic acidosis;
• Participants who have had a cardiovascular event (acute myocardial infarction, acute coronary syndrome, recent onset of stable angina, stroke, unstable congestive heart failure requiring change in treatment), who underwent a revascularization procedure or vascular surgery in the six months prior to screening;
• Known heart failure, class III to IV (New York Heart Association);
• Moderate or severe renal insufficiency;
• Participant with altered liver function, defined by serum levels of aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase above three times the upper limit of normal or bilirubin \> 1.5 times the upper limit of normal;

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Investigational site

Hortolândia, São Paulo, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Central Study Contacts

Alexandra F D Alves, MSc

CONTACT

1938878917; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: February 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)