Type II Diabetes
Conditions
Keywords
Type II diabetes mellitus
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus
Interventions
DRUGPIEMONTE
Piemonte association 1 coated tablet once a day
OTHERPIEMONTE PLACEBO
Placebo of Piemonte association 1 coated tablet once a day
DRUGEMPAGLIFLOZIN
Empagliflozin 25 mg 1 coated tablet once a day
OTHERPLACEBO EMPAGLIFLOZIN
Placebo of empagliflozin 25 mg 1 coated tablet once a day
DRUGPIOGLITAZONE
Pioglitazone 30 mg 1 tablet once a day
OTHERPLACEBO PIOGLITAZONE
Placebo of pioglitazone 30 mg 1 tablet once a day
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 previous therapies at stable doses within 3 months.
Exclusion criteria
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants; * History of alcohol abuse or illicit drug use; * Participation in a clinical trial in the year prior to this study; * Pregnancy or risk of pregnacy and lactating participants; * Known hypersensitivity to any of the formula compounds; * Type 1 diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin | 120 days | Change from baseline in glycated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 150 days | Incidence and severity of adverse events recorded during the study |
Countries
Brazil
Contacts
Primary ContactArthur M Kummer, MD, PhD
Outcome results
None listed