None listed
Conditions
Interventions
Group 1 Type of group
15 mg of pioglitazone BID (total daily dose of 30 mg) for 24 weeks
Group name:Group 3 Type of group
15 mg pioglitazone / 850 mg metformin BID (total daily dose of 30 mg pioglitazone / 1700 mg metformin) for 24 weeks
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • The patient is a man or woman 18 years of age or older. • The patient has type 2 diabetes. • The patient has not received treatment with antidiabetic medication in the 12 weeks prior to selection, except for short-term use defined as 7.5% and <10.0% in the selection. NOTE: If the patient does not qualify based on this criterion alone, Ale´s analysis can be repeated in a week. • The patient has a body mass index (BMI) <45 kg / m ^. • The patient has received advice on lifestyle modification for type 2 diabetes that includes diet and exercise. • Women of childbearing age (ie, unsterile and pre-menopausal) who are sexually active agree to use an appropriate method of contraception (defined in the informed consent form) from the selection and throughout the study. • The patient is stable as determined by the doctor (ie, through the medical history and physical examination). • The patient or legally acceptable representative of the patient signs a written informed consent form before the start of any study procedure.
Exclusion criteria
Exclusion criteria: • The patient has type 1 diabetes. • The patient has unstable angina or heart failure of any etiology with functional class III or IV according to the New York Heart Association (NYHA) • The patient has a history of myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, aorto-coronary bypass, or transient ischemic attack in the 6 months prior to the Selection. • The male patient has a creatinine level> 1.5 mg / dL (> 133 pmol / L) or the female patient has a creatinine level> 1.4 mg / dL (> 124 pmol / L). • The patient has a triglyceride level> 500 mg / dL (> 5.65 mmol / L). • The male patient has a hemoglobin level <10.5 g / dL (<105 g / L) or the female patient has a hemoglobin level <10.0 g / dL (<100 g / L). • The patient has a level of alanine aminotransferase (ALT) greater than 2.5 times the normal upper limit, active liver disease, or jaundice. • The patient has a history of drug abuse (defined as the consumption of illicit drugs) or a history of alcohol abuse (defined as daily or regular consumption of more than two alcoholic drinks per day) within 2 years prior to the selection. • The patient has been discontinued therapy with a thiazolidinedione (TZD) or metformin due to lack of efficacy or clinical or laboratory signs of intolerance. • The patient is a pregnant woman, intends to become pregnant during the study or is breastfeeding. • The patient has a prior history of cancer, except stage 1 squamous cell or basal cell carcinoma, which has not been in remission for at least 5 years prior to the first dose of the study medication. • The patient has a history of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. • The patient has taken or is expected to take medications excluded as indicated in section 7.3. • The patient has any disease or condition in the selection or randomization that would compromise the safety of the patient, could affect the life expectancy, or make difficult the successful management and follow-up of the patient according to the protocol. • The patient does not want or is not able to comply with the protocol or scheduled appointments. • The patient is not able to understand the verbal or written English language or any other language for which a certified translation of the approved informed consent is available. • The patient is currently participating in another research study or has participated in a research study within 30 days prior to randomization. • The patient is an employee of the research center, or is a direct relative (ie, spouse, parent, child, brother) of an employee of the study center who is involved in conducting this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:change from the baseline visit in the value of Ale in week 24 or in early termination if the patient does not complete the week visit 24 Measure:Change in the A1c Timepoints:Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change from baseline in fasting plasma glucose Measure:Change from baseline in fasting plasma glucose Timepoints:Week 24 ; Outcome name:Measurement of fasting insulin Measure:Fasting insulin change Timepoints:Week 24 ; Outcome name:The evaluation of the homeostasis model (HOMA) Measure:The evaluation of the homeostasis model (HOMA) Timepoints:During treatment ; Outcome name:Changes in high sensitivity C-reactive protein (hs-CRP) Measure:Changes in high sensitivity C-reactive protein (hs-CRP) Timepoints:Week 24 ; Outcome name:Measurement of adiponectin, lipid parameters, and lipid fractionation in week 24 Measure:Changes in adiponectin, lipid parameters, and lipid fractionation in week 24 Timepoints:Week 24 | — |
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed