None listed
Conditions
Interventions
GROUP 1 Type of group
All patients will start with a period of dose stabilization of 6 to 12 weeks, in which the ideal doses of Metformin (at least 1500 mg, QD) and Rosiglitazone (at least 4 mg, QD) will be established. After this, a Simple Blind Transition Period will follow, in which the doses of Metformin and Rosiglitazone will be continued and Sitagliptin Placebo, PO, QD will be added. for a total of 2 weeks. Finally this group will enter the Period of Active Treatment: Where it will continue with the established
All patients will start with a period of dose stabilization of 6 to 12 weeks, in which the ideal doses of Metformin (at least 1500 mg, QD) and Rosiglitazone (at least 4 mg, QD) will be established. After this, a Simple Blind Transition Period will follow, in which the doses of Metformin and Rosiglitazone will be continued and Sitagliptin Placebo, PO, QD will be added. for a total of 2 weeks. Finally this group will enter the Period of Active Treatment: Where will continue with the established do
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a) The patient suffers from diabetes mellitus type 2 (T2DM). b) The patient is a man or woman and is ≥ 18 and ≤ 78 years of age on the day he signs the consent. c) The patient understands the study procedures, alternative treatments available and the risks involved in the study and voluntarily accepts to participate in the study. d) The patient is male, or a woman whose chances of conceiving are very improbable: 1) The patient is male. 2) The patient is a woman surgically sterilized. 3) The patient is a post-menopausal woman ≥ 45 years of age whose last menstruation occurred> 2 years ago. 4) The patient is a non-sterilized pre-menopausal woman who agrees to: (1) use 2 adequate contraceptive methods to prevent pregnancy OR (2) abstain from having heterosexual relationships throughout the study, starting with the Screening Visit and during 14 days after taking the last dose of the study drug. e) The patient currently receives stable doses of dual AHA therapy. f) The patient has a body mass index (BMI)> 20 kg / m2 and <43 kg / m2.
Exclusion criteria
Exclusion criteria: a) The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. b) The patient required insulin within the previous 3 months. c) The patient has been taking Byetta® (exenatide) within the previous 3 months. d) The patient is following a weight reduction program and is not in the maintenance phase or has started a treatment with a weight loss drug within the previous two months. e) The patient is receiving or is likely to require treatment with immunosuppressive / immunomodulatory agents during the study or the patient is receiving or is likely to require treatment for ≥ 14 consecutive days or repeated courses of pharmacological doses of corticosteroids. f) The patient has undergone surgery within the previous 30 days or has scheduled major surgery. g) The patient has received treatment with an investigational drug within the previous 3 weeks or is participating in a clinical trial. h) The patient has been previously treated with sitagliptin (MK-0431). i) The patient has a history of hypersensitivity or intolerance to the use of metformin or a PPARy agonist. j) The patient presents new signs or symptoms of coronary heart disease or the worsening thereof within the last 3 months or suffers from any of the following disorders within the last 6 months: • Acute coronary syndrome. • Coronary artery intervention. • Stroke or transient ischemic neurological disorder. k) The patient has a severe peripheral vascular disease. l) The patient suffers from congestive heart failure requiring pharmacological therapy or NYHA Class II, III or IV congestive heart failure. m) The patient is pregnant or nursing or expects to conceive within the projected duration of the study. n) The patient expects to donate their eggs within the projected duration of the study. o) The patient is HIV positive. p) The patient suffers from viral hepatitis. q) The patient has a clinically important hematologic disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Glycosylated hemoglobin (HbA1c) in peripheral blood. Measure:Change in Week 18 with respect to baseline HbA1c. Timepoints:Week 18. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Laboratory evaluations: Serum glucose values ​​in fasting (FPG), glucose at 2 hours after eating food, HbA1c. Pre and post prandial concentrations of insulin, proinsulin, proinsulin to insulin ratio and C-peptide. Using these data, the B cell reserve and insulin resistance will be calculated using mathematical models: HOMA-B and HOMA-IR. The total area under the curve (AUC) and its oscillation will be calculated based on the food tolerance test (glucose, insulin, proinsulin and C-peptide). For the lipid profile will be requested: Total cholesterol, HDL-C, LDL-C, triglycerides. Measure:1) Change with respect to the FPG baseline of 2 hours in week 18. 2) Change with respect to baseline FPG in week 18. 3) Change from baseline in HbA1c in week 54. 4) Change with respect to the FPG baseline of 2 hours in week 18. 5) Change with respect to the FPG baseline in week 54. 6) Change with respect to the baseline in pre and postprandial concentrations of 2 hours of glucose, insulin, proinsulin, proportion of proinsulin to insulin and peptide C, and in HOMA-B and in HOMA-IR in Week 18 and Week 54. 7) Change from the baseline in the total AUC and AUC values for level oscillation. 8) Percentage of change from the baseline in the lipid parameters. Timepoints:Weeks 18 and 54. ; Outcome name:Evaluation of adverse effects, determining its severity, duration, the action performed and its relationship with the test drug. Alterations in the physical examination, vital signs and body weight. Laboratory tests: Biochemical, hepatic and hematological panels. Urinalysis and urine pregnancy tests. 12-lead ECG. Measure:Safety of the treatment. Timepoints:Adverse effects, weight and vital signs: Day 1 and weeks 6, 12, 18, 24, 30, 36, 42, 48 and 54. Physical exam, ECG: Day 1 and weeks 18 and 54. Laboratory tests: Day 1 and weeks 6, 18, 30, 42 and 54. | — |
Countries
Canada, China, Italy, Malasya, Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed