Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus.

Type2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03766750
• Other study ID #: EMS0318-LIMA
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 2021
• Est. completion date: November 2023

Study information

• Verified date: July 2022
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Drug:
• LIMA association
1 coated tablet, oral, once a day.
• Tradjenta
1 coated tablet, oral, once a day.
• Forxiga
1 coated tablet, oral, once a day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of glycated hemoglobin levels measured between the first visit and the last visit.		120 days
Secondary	Incidence and severity of adverse events recorded during the study.		210 days