None listed
Conditions
Interventions
GROUP 1 Type of group
Stable dose period / dose adjustment: Duration of 12 weeks. All patients will discontinue their usual hypoglycaemic drugs and will take Metformin with a minimum dose of 1500 mg, PO, QD, the dose may be increased according to clinical presentation.
Single Blind Period: Duration of 2 weeks. This group will continue with the dose of Metformin established PO, QD + Sitagliptin Placebo PO, QD.
Double Blind Treatment Period: Duration of 30 weeks. This group will be treated with the individual dos
Stable dose period / dose adjustment: Duration of 12 weeks. All patients will discontinue their usual hypoglycaemic drugs and will take Metformin with a minimum dose of 1500 mg, PO, QD, the dose may be increased according to clinical evaluation.
Single Blind Period: Duration of 2 weeks. This group will continue with the dose of Metformin established PO, QD + Sitagliptin Placebo PO, QD.
Double Blind Treatment Period: Duration of 30 weeks. This group will be treated with the established indi
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient has T2DM. 2. The patient is ≥ 18 and ≤ 78 years of age. 3. The patient is not pregnant or breastfeeding and does not plan to become pregnant during the study or during the post-study follow-up period. 4. The patient is male, or is a woman with a high probability of not conceiving: a) The patient is male. b) The patient is a surgically sterilized woman. c) The patient is a post-menopausal woman of ≥ 45 years of age whose last menstrual period was> 2 years ago. d) The patient is a non-sterilized pre-menopausal woman and agrees to: (1) Use 2 adequate contraceptive methods to avoid pregnancy OR (2) Refrain from having heterosexual relationships throughout the study, starting with the Visit 1 and for 14 days after receiving the last dose of study medication. 5. The patient understands the study procedures and agrees to participate in the study by providing written informed consent. 6. The patient falls into one of the following categories and according to the review of the current diet and medical regimen as well as the level of HbA1c in the Screening Visit A ​​/ Visit 1, the investigator considers that the patient has probabilities of meet the inclusion criteria of HbA1c ≥ 8% and ≤ 11% of Visit 4 after the stable dose period with metformin monotherapy ≥1500 mg / day, as indicated by a yes response to one of the following statements : a) The patient is currently receiving monotherapy with metformin or other single oral AHA and has an HbA1c level ≥ 8% at the A / Visit Screening Visit 1. OR b) The patient is currently receiving metformin in combination with another oral AHA and has a HbA1c level ≥ 7.5% and ≤ 10.5% in the A / Visit 1 Screening Visit.
Exclusion criteria
Exclusion criteria: 1. The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. 2. The patient required insulin therapy within the previous 8 weeks. 3. The patient has been receiving a PPARy or Byetta® agent within the previous 12 weeks. 4. The patient is participating in a weight loss program and is not in the maintenance phase, or the patient has begun receiving medication to lose weight within the previous 8 weeks. 5. The patient is receiving, or is likely to require, treatment with corticosteroids for ≥ 14 consecutive days or repeated courses of pharmacological doses of corticosteroids. 6. The patient is receiving an immunosuppressive / immunomodulatory agent. 7. The patient has received treatment with an investigational drug within 12 weeks prior to Visit 1 or is currently participating in any other clinical trial or has been previously participating in a sitagliptin study. 8. The patient has undergone surgery within the previous 30 days or has been scheduled for major surgery during the study. 9. The patient has a history of intolerance or hypersensitivity to metformin or has a contraindication to taking metformin. 10. The patient has a level of AST and / or ALT> 2 times the upper limit of normal (ULN). 11. Serum creatinine level ≥ 1.4 mg / dL (123.8 pmol / L) in men and ≥1.3 mg / dL (114.9 pmol / L) in women or estimated creatinine clearance 600 mg / dL (> 6.8 mmol / L) and is not likely to respond to the diet / exercise regimen and / or medication. 23. The patient has a history of malignant disease. 24. The patient has a BMI 43 kg / m2 25. The patient has a history of alcohol or drug abuse within the last 3 years or is unwilling to abide by the restrictions of alcohol consumption. 26. The patient has any other condition or therapy that could pose a risk to the patient or make his participation not beneficial to him. 27. The patient has poor mental function or there is any other reason to anticipate that the patient will have difficulties in meeting the requirements of the study. 28. The patient has a past history of recurrent poor compliance with medications or the patient is unlikely to be able to maintain consistent good compl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement in peripheral blood of glycosylated hemoglobin (HbA1c). Measure:Change in HbA1c in Week 18. Timepoints:Week 18. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement in peripheral blood of glycosylated hemoglobin (HbA1c). Postprandial Glucose: Glucose samples will be taken at 0 minutes (just before food intake) and at 60 and 120 minutes, after the patient begins to eat food. This test will use a predominantly solid standardized meal. Fasting glucose: Glucose samples will be taken, after an 8-hour fast. Measure:Secondary efficacy: 1) Change from baseline in postprandial glucose concentration of 2 hours in Week 18. 2) Change from baseline in FPG in Week 18. 3) Change from baseline in HbA1c in Week 30. Timepoints:Postprandial and fasting glucose: Week 18 HbA1C: Week 30 ; Outcome name:Proinsulin, Insulin and Peptide C: Serum concentrations will be measured at 0 minutes (just before food intake) and at 60 and 120 minutes, after the patient begins to ingest the food. This test will use a predominantly solid standardized meal. B-cell pancreatic function (HOMA-B) and insulin resistance index (HOMA-IR): These are models that quantify B cell function and insulin resistance based on glucose and insulin levels. The area under the total curve (AUC) and the excursion AUC (AUC of the increase above the level at the beginning of the consumption of the food): It will be calculated based on the variation of the glucose in the oral tolerance test to the glucose. Lipid profile: LDL-C, HDL-C, triglycerides, total cholesterol. Measure:1) Change with respect to the Proinsulin baseline. 2) Change with respect to the basal of the proinsulin to insulin ratio. 3) Change with respect to the baseline in insulin and peptide C concentrations before food and 2 hours after food. 4) Change with respect to the baseline of HOMA-B and HOMA-IR. 5) Change with respect to the basal values ​​of the total AUC and the AUC of the excursion. 6) Change with respect to basal lipid parameters. Timepoints:Proinsulin, insulin, C-peptide, HOMA-b, HOMAR-IR, total AUC and AUC excursion: Week 18. | — |
Countries
Austria, Israel, Mexico, Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed