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

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

Study Overview

• Status: Withdrawn
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Drug: LIMA association; Drug: Tradjenta; Drug: Forxiga

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIMA	Drug: LIMA association; 1 coated tablet, oral, once a day.; Other Names: EMS association
Active Comparator: Tradjenta®	Drug: Tradjenta; 1 coated tablet, oral, once a day.; Other Names: Linagliptin 5 mg
Active Comparator: Forxiga®	Drug: Forxiga; 1 coated tablet, oral, once a day.; Other Names: Dapagliflozin 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of glycated hemoglobin levels measured between the first visit and the last visit.	120 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events recorded during the study.	210 days

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Dapagliflozin; Linagliptin
• Other Study ID Numbers: EMS0318-LIMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No