None listed
Conditions
Interventions
Group 1 Type of group
While receiving a stable dose of metformin (at a dose of at least 1500 mg per day for a minimum of 12 weeks) they will receive Sitagliptin 100 g q.d. for 30 weeks.
Group name:Group 2 Type of group
While receiving a stable dose of metformin (at a dose of at least 1500 mg per day for a minimum of 12 weeks) they will receive Glimepiride: Initial dose of 1 mg, increase the dose, as necessary, up to the maximum dose of 5 mg. mg qd for 30 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • The patient has T2DM. • The patient is> 18 years of age on the day of signing the informed consent. • The patient is receiving a stable dose and is expected to be able to remain in a stable dose (s) of metformin (at a dose of at least 1500 mg per day, for a minimum of 12 weeks) with inadequate glycemic control, that is, HbA1c> 6.5% and 45 years of age in whom> 2 years have passed since her last menstruation. • The patient is a non-sterilized premenopausal woman who accepts to abstain from heterosexual activity or to use an adequate contraceptive method to prevent pregnancy. • Patient shows compliance> 85% (as measured by tablet count) with single-blind placebo tablets during transition.
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. Patient possibly has type 1 diabetes, according to the researcher´s evaluation, confirmed with a C peptide 14 consecutive days or during repeated cycles. Note; Inhaled, nasal, and topical corticosteroids are allowed. • The patient is receiving or is likely to require an immunosuppressive / immunomodulatory agent (eg, cyclosporine, methotrexate, etanercept). • The patient has undergone surgery that required general anesthesia within the previous 30 days or the patient has planned surgery. Note: Patients who have planned minor surgery can enroll after approval of the Merck medical monitor. • The patient has received treatment with an investigational drug within the previous 8 weeks. • The patient has a serum ALT or AST> 2.0 times the Upper Normal Limit (ULN). Note: Patients whose ALT or serum AST exceeds this limit can be re-evaluated once if the investigator considers that the value does not reflect the clinical status of the patient. • The patient has either a serum creatinine> 1.4 mg / dL (123.8 | umoI / L) in men and> 1.3 mg / dL (114.9 umol / L) in women or estimated creatinine clearance (using the Cockcroft-Gault formula) ) 160 mm Hg or diastolic> 90 mm Hg). • The patient has a triglyceride (TG) level> 500 mg / dL (6.78 mmol / L). • The patient has a TSH value outside of the normal laboratory range. Note: Patients with mild subclinical hypothyroidism [ie without symptoms, slight elevation of TSH (ie <8 mlU / mL) and normal levels of thyroxine] and for whom the investigator determines that the treatment is not clinically indicated, can participate • The patient has cirrhosis or active liver disease (different from fatty liver). • The patient suffers from a severe peripheral vascular disease (for example, manifested by claudication with minimal activity, ischemic ulcer that does not heal, or disease that probably requires surgery, such as a bypass or angioplasty) • The patient suffers from congestive heart failure that requires pharmacological therapy or any other condition (s) for which metformin is contraindicated in accordance with the approved metformin label in the country in which it is administered. which is the location of the study. • The patient is HIV positive (according to the medical history evaluation). • The patient has a clinically important hematologic frastoma (for example, aplastic anemia, myeloproliferat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting blood will be drawn (at least 12 hours after the last meal / food intake, with the exception of water and drugs different from those of the study) at the designated visits to determine the glycemic efficacy parameters Measure:Variation in HbA1c levels Timepoints:Week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of plasma glucose during the study Measure:Change from baseline in fasting plasma glucose (FPG) Timepoints:Week 30 ; Outcome name:Fasting blood will be drawn (at least 12 hours after the last meal / food intake, with the exception of water and drugs different from those of the study) at the designated visits to determine the glycemic efficacy parameters Measure:Objective of HbA1c <6.5% and <7.0% Timepoints:Week 30 ; Outcome name:Measurement of low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], and triglycerides [TG] during the study. Measure:Variation in the levels of the lipid panel, the percentage change with respect to the baseline in Week 30 Timepoints:Week 30 ; Outcome name:Record of hypoglycaemic events during the study Measure:incidence of hypoglycemic events until Week 30 Timepoints:Week 30 ; Outcome name:Measurement of body weight during the study Measure:The change from the baseline in body weight will be analyzed in Week 30 Timepoints:Week 30 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed