None listed
Conditions
Interventions
Group 1 Type of group
patients randomized to the sitagliptin group will receive fixed-dose combination tablets of MK-0431 A and 1 placebo tablet corresponding to 45 mg pioglitazone for 40 weeks
Group name:Group 2 Type of group
patients randomized to the pioglitazone group will receive pioglitazone 45 mg once a day, and placebo tablets corresponding to MK-0431 A for 40 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient has T2DM. • The patient is> 18 and 7.5% and 45 years old with> 2 years since her last menstruation. • The patient is a non-sterilized pre-menopausal woman and accepts to abstain from heterosexual activity or otherwise use an adequate method of contraception • The patient understands the procedures of the. study, alternative treatments available and the risks involved in the study and voluntarily agree to participate giving written informed consent.
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. • The patient has symptomatic hyperglycemia that requires the immediate initiation of antihyperglycemic therapy. • Hypersensitivity or contraindication to the drugs of biguanide (ie, metformin), pioglitazone hydrochloride (ie, ACTOS®), or thiazolidinedione drugs. • The patient is following a program to lose weight and is not in the maintenance phase, or the patient started taking a weight-loss drug (eg, orlistat, sibutramine, rimonabant) within 8 weeks prior to Visit 1 . • The patient has received treatment with an investigational drug within the previous 3 months or otherwise, is participating in another clinical trial. • The patient has previously received clinical treatment with sitagliptin, vildagliptin, or exenatide or has previously participated in a clinical trial and received any inhibitor of DPP-4 or incretin mimetic. • The patient is receiving lipid-modifying drugs (or needs to start therapy with lipid-modifying drugs) and will not have a stable dose for at least 4 weeks before Visit 3. • The patient is receiving or is likely to need treatment with immunosuppressive / immunomodulatory agents (eg, cyclosporine, methotrexate, etanercept), or the patient is receiving or likely to need treatment for> 14 consecutive days or repeated dose cycles Pharmacological effects of corticosteroids. • The patient needs therapy or is receiving therapy with CYP2C8 inhibitors (such as gemfibrozil) or CYP2C8 inducers (such as rifampin). • The patient has undergone surgery within 30 days prior to Visit 1 or has scheduled major surgery. • Concomitant Conditions or Diseases of Organs and Systems • The patient has new or worsening symptoms or signs of coronary heart disease or congestive heart failure within the past 3 months, or has had any of the following conditions within the past 3 months: • Acute coronary syndrome (eg, MI or unstable angina) • Coronary artery intervention (eg, CABG or PTCA) • Cerebrovascular accident / transient ischemic neurological disorder • The patient has congestive heart failure of any NYHA class (ie Class I to IV). • The patient had at Visit 1 a systolic blood pressure of> 165 mm Hg or a diastolic blood pressure of> 95 mm Hg and it is considered unlikely that the blood pressure falls below these limits for Visit 3 with an adjustment in your antihypertensive regimen • The patient suffers from a severe peripheral vascular disease (manifested, for example, by claudication with minimal activity, an ischemic ulcer that does not heal, or a disease that probably requires an intervention, such as a bypass or angioplasty). • The patient has active liver disease (other than a nonalcoholic fatty liver disease), has active viral hepatitis (chronic Hepatitis B or Hepatitis C) as assessed by medical history or has cirrhosis. • The patient has an active nephropathy (ie, nephrotic syndrome or glomerulonephritis). • The patient has chronic myopathy, or a progressive neuromuscular or neuromuscular disorder (eg, polymyositis, or multiple sclerosis). • The patient is HIV positive (as assessed by medical history). • The patient has a clinically significant hematologic disorder (eg, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia). • The patient is receiving treatment for hyperthyroidism. • The patient has a history of malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of HbA1c Measure:change of HbA1c with respect to baseline in Week 12 Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Medicion de la HbA1c Measure:The percentage of patients who reach HbA1c <7.0% in Week 40 Timepoints:Week 40 ; Outcome name:As determined by the food tolerance test Measure:the change of post prandial glucose at 2 hours (PPG) with respect to the baseline Timepoints:2 hours ; Outcome name:change of FPG with respect to the baseline at the end of each phase Measure:change of FPG with respect to the baseline at the end of each phase Timepoints:After treatment ; Outcome name:Measurement of body weight Measure:Change in body weight with respect to baseline in Week 40 Timepoints:Week 40 | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed