Type2 Diabetes MellitusPhase 3NCT03766750
Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus.
A Phase 3 study testing LIMA association, Tradjenta and Forxiga in people with Type2 Diabetes Mellitus, run by EMS.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Lima association in the control of type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- LIMA association, Tradjenta and Forxiga
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of both sexes, aged 18 years or more;
- Participants presenting the diagnosis of type II diabetes mellitus, which have already received previous dietary and physical exercise guidance, who are not receiving any antidiabetic treatment, defined as never taking any antidiabetic medication, or in antidiabetic therapy after being subjected to a washout period;
- Treatment-naive participants with HbA1c between 7.5% and 10.5% and pretreated patients with HbA1c between 7,5% and 9,5% at the screening visit;
- Patients with HbA1c between 7.5% and 10.5% at the randomization visit;
- Participants with BMI (body mass index) > 19 Kg/m2 and ≤ 45 Kg/m2.
- Signed consent.
Who cannot join
- Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- History of alcohol abuse or illicit drug use;
- Participation in clinical trial in the year prior to this study.
- Fasting glycemia above 300 mg/dL;
- Risk factors for severe volume depletion;
- Diuretic use less than 60 days, except for spironolactone;
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- History of diabetic ketoacidosis;
- Medical history of acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to informed consent;
- Impaired hepatic function;
- Impaired renal function and end stage renal disease;
- Bariatric surgery in the last two years and/ or other gastrointestinal surgeries;
- Current medical history of cancer and/ or cancer treatment in the last 5 years;
- Medical history of blood dyscrasia or any other hemolytic disorders;
- Medical history of pancreatitis and chronic pancreatitis;
- Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months;
- Current and prolonged treatment for more than 15 days with systemic steroids at the moment of informed consent;
- Any other uncontrolled endocrine disorder, except type 2 diabetes mellitus;
- History hypersensitivity to the active ingredients used in the study;
- Pregnancy or risk of pregnancy and lactating patients;
- Systemic disease that is not controlled and can put the participant at risk;
About this study
Official title: Randomized, Double-blind, Multicenter, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus
The purpose of this study is to evaluate the efficacy and safety of Lima association in the control of type 2 diabetes mellitus
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- LIMA association, Tradjenta, Forxiga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIMA associationDrug
Also called EMS association
1 coated tablet, oral, once a day.
TradjentaDrug
Also called Linagliptin 5 mg
1 coated tablet, oral, once a day.
ForxigaDrug
Also called Dapagliflozin 10 mg
1 coated tablet, oral, once a day.
| Study group | Role | What they receive |
|---|---|---|
| LIMA | Experimental | Not described Receives: Drug: LIMA association |
| Tradjenta® | Active comparator | Not described Receives: Drug: Tradjenta |
| Forxiga® | Active comparator | Not described Receives: Drug: Forxiga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
Measured: 120 days
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study.
Measured: 210 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study startDec 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766750
- Sponsor's protocol ID
- EMS0318-LIMA
- Status last verified
- Jul 2022
- First submitted
- 5 Dec 2018
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multicenter, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03766750
- Acronym / sponsor ID
- EMS0318-LIMA
- Conditions
- Type2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Dec 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 6 Dec 2018 (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 Lima association in the control of type 2 diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LIMA | Experimental | Drug: LIMA association |
| Tradjenta® | Active comparator | Drug: Tradjenta |
| Forxiga® | Active comparator | Drug: Forxiga |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants of both sexes, aged 18 years or more;
- Participants presenting the diagnosis of type II diabetes mellitus, which have already received previous dietary and physical exercise guidance, who are not receiving any antidiabetic treatment, defined as never taking any antidiabetic medication, or in antidiabetic therapy after being subjected to a washout period;
- Treatment-naive participants with HbA1c between 7.5% and 10.5% and pretreated patients with HbA1c between 7,5% and 9,5% at the screening visit;
- Patients with HbA1c between 7.5% and 10.5% at the randomization visit;
- Participants with BMI (body mass index) > 19 Kg/m2 and ≤ 45 Kg/m2.
Key exclusion criteria (20 listed)
- Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- History of alcohol abuse or illicit drug use;
- Participation in clinical trial in the year prior to this study.
- Fasting glycemia above 300 mg/dL;
- Risk factors for severe volume depletion;
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 |
|---|---|---|
| LIMA associationAlso: EMS association1 coated tablet, oral, once a day. | Drug | LIMA |
| TradjentaAlso: Linagliptin 5 mg1 coated tablet, oral, once a day. | Drug | Tradjenta® |
| ForxigaAlso: Dapagliflozin 10 mg1 coated tablet, oral, once a day. | Drug | Forxiga® |
Primary outcome
Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
Time frame: 120 days
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 210 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LIMA association, Tradjenta and Forxiga in people with Type2 Diabetes Mellitus, run by EMS.
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 6 inclusion and 20 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: withdrawn, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of glycated hemoglobin levels measured between the first visit and the last visit. (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 27 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.