None listed
Conditions
Interventions
Group 1 Type of group
pioglitazone 15 mg + placebo once a day for 24 weeks
Group name:Group 6 Type of group
pioglitazone HCI 45 mg + TAK-536 40 mg once a day 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 subject must be male or female, 18 years of age or older, with type 2 diabetes (hemoglobin Ale [HbA1c] greater than or equal to 8.0% or less than 10.0% in the selection and random distribution). • IF the subject is receiving antihypertensive treatment. You must take a stable dose for a minimum of 8 weeks before the selection. • The subject should have clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) within the reference range for laboratory tests unless the researcher or sponsor considers the results clinically significant for inclusion in this study. • Subject has been on a stable diet and exercise program and oral antiglyzemic treatment including sulfonylurea or metformin for 8 weeks before selection.
Exclusion criteria
Exclusion criteria: • The subject has HbA1c less than 8.0% or greater than or equal to 10.0% in the selection or • Random distribution. • The subject is currently taking an angiotensin II receptor blocker (BRA). • The subject has uncontrolled hypertension defined as SBP greater than 160 mmHg and DBP greater than 100 mmHg. • The subject has a SBP less than or equal to 110 mmHg and / or a DBP less than or equal to 60 mmHg. • The subject is currently taking or expected to take the following medications: antidiabetic compounds, including thiazolidinediones (TZDs), and / or insulin; tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, phenothiazines; dietary drugs, amphetamines or their derivatives: lithium; medicines for the common cold of chronic use; or non-steroidal anti-inflammatory drugs (NSAIDs) for chronic use (including acetylsalicylic acid [ASA] greater than 325 mg / day or cyclooxygenase inhibitors [COX-2]). • Subject has unstable angina or heart failure of any etiology with NYHA functional class MI or IV. • The subject has a history of myocardial infarction. • Subject has clinically significant cardiac conduction defects (eg, second or third degree atrioventricular (AV) block, left bundle branch block (LBB), sick sinus syndrome, atrial fibrillation or flutter). • Subject has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing´s syndrome). • The subject has a history of collagen vascular disorder (eg, systemic lupus erythematosus, scleroderma) in the last 5 years. • The subject has a body mass index (BMI) greater than 39 kg / m2. • Subject has moderate to severe, significant renal dysfunction (creatinine greater than 2.4 mg / dL). If the subject is receiving metformin, and has a creatinine greater than 1.8 mg / dl for men, or greater than 1.5 mg / dl for women. • The subject has a history of drug dependence (defined as the illegal use of drugs) or a history of alcoholism (defined as regular or daily consumption of more than 4 drinks a day) in the last 2 years. • The subject has a history of cancer, in addition to basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of the study medication. (This criterion does not include those with basal cell or squamous cell skin carcinoma in Stage 1). • The subject has type 2 diabetes with clinically important retinopathy or peripheral or autonomic neuropathy. • The subject has a level of alanine aminotransferase (ALT) or aspartate aminotransferase (ASI) greater than 3 times the upper limit of normal, active liver disease or jaundice. • The subject is not willing or unable to comply with the protocol or scheduled visits. Pregnant women, or who intend to get pregnant during the course of the study, or are in the lactation stage. • The subject is currently participating in another research study or has participated in a research study 30 days before the random distribution. • The subject has some other serious illness or disease in the selection (or random distribution) that would compromise the subject´s safety, affect life expectancy, or hinder their successful treatment and follow-up according to the protocol. • The subject is hypersensitive to BRAs. • The subject is hypersensitive to TZDs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change from Baseline in HbA1c in the Final Visit of the double blind treatment period Measure:Change from Baseline in HbA1c in the Final Visit of the double blind treatment period Timepoints:24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Respective changes to Baseline in GPA, body weight, SBP / DBP, edema (peripheral), excretion of microaibuminuria and inflammatory markers (PCR-AS and MMP-9). Measure:Respective changes to Baseline in GPA, body weight, SBP / DBP, edema (peripheral), excretion of microaibuminuria and inflammatory markers (PCR-AS and MMP-9). Timepoints:24 weeks | — |
Countries
Argentina, Chile, Mexico, Peru, United States
Outcome results
None listed