None listed
Conditions
Interventions
Group 1 Type of group
Sitagliptin / Metformin 50/1000 mg b.i.d. for 28 weeks
Group name:Group 2 Type of group
Pioglitazone 45 mg q.d for 28 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. 4) The patient is a non-sterilized pre-menopausal woman and accepts to abstain from having heterosexual activity or otherwise use an adequate method of contraception: • The patient understands the study procedures, alternative treatments available and the risks involved in the study and voluntarily agrees to participate by giving written informed consent. In Visit 3 / Day 1 / Randomization • The patient has> 85% compliance with the placebo treatment during the single blind transition as measured by the tablet count performed at the site.
Exclusion criteria
Exclusion criteria: • The patient has a history of type II diabetes mellitus or a history of ketoacidosis. The investigator in his evaluation of the patient has determined that he possibly has type 1 diabetes confirmed with a C-peptide value 14 consecutive days: or repeated courses of pharmacological doses of corticosteroids. • The patient has undergone surgery within 30 days prior to Visit 1 or has scheduled major surgery. • The patient needs therapy with CYP2C8 inhibitors (such as gemfibrozil) or CYP2C8 inducers (such as rifampin) (see information for pioglitazone, section 7). • The patient has new or worsening symptoms or signs of coronary heart disease within the past 3 months, or has had any of the following conditions within the past 3 months: • Acute coronary syndrome (eg, IM or unstable angina) • Coronary artery intervention (eg, CABG or PTCA) • Stroke / transient ischemic neurological disorder • The patient has congestive heart failure of any NYHA class (ie Class I to IV) (see Appendix 6.1). • 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 non-alcoholic 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 significant c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary hypothesis related to the superiority of sitagliptin / metformin in doses of 50/1000 mg b.i.d. with respect to pioglitazone in a dose of 45 mg q.d. to reduce HbA1c in Week 32 Measure:Change from baseline (Visit 3 / Day 1) in HbA1c in Week 32 Timepoints:Week 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:They will include the collection of adverse events, physical examination and vital signs, and laboratory safety studies. Measure:Safety assessments Timepoints:Week 32 ; Outcome name:obtained by MTT, proinsulin, and insulin, measured at point 0 Measure:Changes in FPG and glucose Timepoints:Week 32 | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed