Type 2 Diabetes MellitusPhase 3DÁLIANCT05886088
Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus
A Phase 3 study testing LID104, Dapagliflozin and Linagliptin in people with Type 2 Diabetes Mellitus, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of LID104 in the treatment of type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- LID104, Dapagliflozin and Linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2024to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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;
- Participants who underwent bariatric surgery in the last two years and/or other gastrointestinal surgeries that may cause chronic malabsorption;
- Medical history of haemoglobinopathies, blood dyscrasia or any other hemolytic disorders;
- Known medical history of pancreatic diseases that may suggest insulin deficiency;
- Known uncontrolled hypothyroidism or hyperthyroidism or thyroid-stimulating hormone (TSH) dosage greater than 1.5 times the reference value;
- Known history of sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte changes or uncontrolled seizures in the six months prior to trial screening, or any other condition that, in the judgment of the investigator, may favor clinically significant alterations in the levels of the enzyme creatine phosphokinase (CPK) or participants with CPK dosages greater than ten times the value considered for normality;
- Participants who started treatment with anti-obesity drugs less than three months ago or with a dose change in the last three months;
- Participants with current and prolonged treatment for more than fifteen days with systemic steroids at the time of informed consent or in the last three months prior to the screening visit;
- Participants on insulin therapy or using oral antidiabetics other than metformin;
- Participants using prohibited medications according to the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Investigational site
Hortolândia, São Paulo
Alexandra F D Alves, MSc
About this study
Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus
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
- Being tested
- LID104, Dapagliflozin, Linagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LID104Drug
Experimental
DapagliflozinDrug
Active comparator
LinagliptinDrug
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c)
Change from baseline in glycated hemoglobin
Measured: 120 days
Secondary outcomes (5)
Fasting blood glucose
Change from baseline in fasting blood glucose
Measured: 120 days
HbA1c reduction to < 7%
Proportion of participants with HbA1c reduction to < 7%
Measured: 120 days
Treatment failure
Proportion of participants who were discontinued from the study because they needed medication other than the study medication for blood glucose control
Measured: Up to 140 days
Body weight
Change from baseline in body weight
Measured: Up to 140 days
Blood pressure
Change from baseline in blood pressure
Measured: Up to 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study startFeb 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 597 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886088
- Sponsor's protocol ID
- LID104-III-0123
- Acronym
- DÁLIA
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05886088
- Acronym / sponsor ID
- DÁLIA / LID104-III-0123
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 597 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of LID104 in the treatment of type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LID104 | Experimental | Drug: LID104The patient must take 1 tablet of LID104 plus 1 tablet of placebo of dapagliflozin and 1 tablet of placebo of linagliptin once a day. |
| Dapagliflozin | Active comparator | Drug: DapagliflozinThe patient must take 1 tablet of dapagliflozin plus 1 tablet of placebo of LID104 and 1 tablet of placebo of linagliptin once a day. |
| Linagliptin | Active comparator | Drug: LinagliptinThe patient must take 1 tablet of linagliptin plus 1 tablet of placebo of LID104 and 1 tablet of placebo of dapagliflozin once a day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LID104Experimental | Drug | LID104 |
| DapagliflozinActive comparator | Drug | Dapagliflozin |
| LinagliptinActive comparator | Drug | Linagliptin |
Primary outcome
Glycated hemoglobin (HbA1c)
Time frame: 120 days
Change from baseline in glycated hemoglobin
5 secondary outcomes
Fasting blood glucose
Time frame: 120 days
HbA1c reduction to < 7%
Time frame: 120 days
Treatment failure
Time frame: Up to 140 days
Body weight
Time frame: Up to 140 days
Blood pressure
Time frame: Up to 140 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LID104, Dapagliflozin and Linagliptin in people with Type 2 Diabetes Mellitus, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra F D Alves, MSc (1938878917 ext. +55, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (HbA1c) (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.