None listed
Conditions
Interventions
Group 1 Type of group
sitagliptin 100 mg / pioglitazone 15 mg orally once a day
Group name:Group 7 Type of group
100 mg sitagliptin orally once a day
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: • The patient has T2DM and is> 18 and 45 years of age in which> 2 years have passed since her last menstruation. and. The patient is a non-sterilized premenopausal woman who agrees to use an adequate contraceptive method. • The patient understands the study procedures, alternative treatments available, and the risks involved in the study, and voluntarily agrees to participate in the study by providing written informed consent. • The patient has not had prior contact with any of the therapies with an AHA (has not received any of the therapies with an AHA for a minimum of 3 months and has not received an AHA for more than 4 weeks in total in the past 3 years before Visit 1) and has an HbAic> 7.5% and 7.5% and 8 weeks) and has an HbA1c> 7.5% and 7% and 7.5% and 85% compliance with the placebo treatment during the simple blind transition, according to the measurement of the tablet count made by the site (for example, in the case of a patient with an interval of 14 days between the visit). 3 and Visit 4, you must have taken at least 12 tablets per bottle).
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis or the patient has a C peptide 14 consecutive days or repeated cycles of fannacologic doses of coiticosteroids. • The patient has received treatment with an investigational drug during the 12 weeks prior to Visit 1 / Screening Visit or is currently participating in any other clinical study (studies with or without drugs). • The patient has had surgery in the past 30 days or has planned major surgery during the study. • The patient has a contraindication to sitagliptin or pioglitazone based on the country label of the research site. • The patient has a medical history of active liver disease such as primary biliary cirrhosis, chronic active hepatitis B or C, or symptomatic cholecystotic disease. • The patient is HIV positive (as assessed by medical history). • The patient presents new signs or symptoms of coronary heart disease, or worsening thereof, in the last 3 months • The patient has congestive heart failure or a history of congestive heart failure. • The patient has a history of malignancy or hematological disorder. • The patient presents any other condition or therapy that, in the opinion of the researcher or Clinical Monitor of Merck, could represent a risk for the patient or make his participation not the most convenient for him. This includes, without limitation, patients who: have poor mental performance, are users of recreational or illicit drugs, or have had a recent history (within the last year) of drug addiction or alcoholism or dependence on drugs or alcohol, or any other reason whereby it is anticipated that the patient will have difficulty in meeting the requirements of the study, such as self-monitoring of blood glucose (SBM), or the ability to maintain high drug compliance. • The patient presents a clinically significant laboratory abnormality based on the results of Visit 1, which, in the opinion of the investigator, represents a risk to the patient if enrolled in the study. • The patient has a positive urine pregnancy test. • The patient presents a clinically significant abnormality in the ECG that, in the opinion of the investigator, represents a risk for the patient if he enrolls in the study. • The patient has a positive urine pregnancy test. • The patient has developed a new medical condition, underwent a change in the status of an established medical condition, developed a laboratory abnormality, or required a new treatment or drug during the placebo transition period, which meets one of the criteria of study exclusion described above or that, in the opinion of the investigator, represents a risk to the patient if enr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Laboratory tests to determine HbA1c levels in blood during the study. Measure:Variation in HbA1c levels Timepoints:Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A mid-urine urine sample will be obtained for urine dipstick analysis and blood samples will be drawn for the biochemical panel with FPG Measure:Variation of FPG Timepoints:Week 24 ; Outcome name:Laboratory tests to determine HbA1c levels in blood during the study. Measure:Achieve target levels of HbA1c (<7.0%; <6.5%) Timepoints:24 weeks ; Outcome name:Laboratory tests to determine levels of Glucose, Insulin, Proinsulin, C-peptide in blood during the study. Measure:Variation in the values of Glucose, Insulin, Proinsulin, Ratio Proinsulin / Insulin, Peptide C Timepoints:Week 24 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed