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

NCT03766750 | Withdrawn Phase 3 DMC

• 1 other identifier: EMS0318-LIMA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Reduction of glycated hemoglobin levels measured between the first visit and the last visit.

  120 days

Secondary Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  210 days

Study Arms (3)

LIMA

EXPERIMENTAL

Drug: LIMA association

Tradjenta®

ACTIVE COMPARATOR

Drug: Tradjenta

Forxiga®

ACTIVE COMPARATOR

Drug: Forxiga

Interventions

LIMA association DRUG

1 coated tablet, oral, once a day.

Also known as: EMS association

LIMA

Tradjenta DRUG

1 coated tablet, oral, once a day.

Also known as: Linagliptin 5 mg

Tradjenta®

Forxiga DRUG

1 coated tablet, oral, once a day.

Also known as: Dapagliflozin 10 mg

Forxiga®

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Interventions

Linagliptin; dapagliflozin

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: December 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07