None listed
Conditions
Interventions
Group 1 Type of group
Sitagliptin 25 mg and the corresponding placebo will be delivered blind as oral tablets and will be administered once a day before breakfast for 54 weeks.
Group name:Group 2 Type of group
The 5 mg glipizide and the corresponding placebo will be delivered blind. Glipizide will be administered at an initial dose of 2.5 mg (1/2 tablet, taped) once a day in the morning before breakfast, and the dose will be adjusted electively (or sham dose adjustment for patients receiving sitagliptin and placebo of glipizide), based on glycemic control up to 20 mg / day (10 mg bid) in 4 steps.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
30 Years to 100 Years
Inclusion criteria
Inclusion criteria: • The patient suffers from type 2 diabetes mellitus (T2DM). • The patient is receiving dialysis (hemodialysis or peritoneal dialysis for at least 6 months) on the day of signing the informed consent. • The patient is> 30 years old on the day of signing the informed consent. • The patient is male. • The patient is a woman sterilized by surgical means. • The patient is a postmenopausal woman> 45 years old with> 2 years since her last menstruation. • The patient is a premenopausal woman, not sterilized and who accepts to abstain from the practice of heterosexual activity or is willing to use an adequate contraceptive method. • The patient understands the study procedures, available alternative treatments and risks involved with the study and voluntarily agrees to participate by providing written informed consent. • The patient is likely to complete the study. • The patient meets one of the following criteria, as indicated by an affirmative response to it: • The patient is not currently in therapy with antihyperglycaemic agents (without therapy for> 12 weeks) and has at Visit 1 an HbA1c> 7% and 7% and 12 weeks) and has an HbA1c> 9% at Visit 1 and after a period of diet and exercise, is likely to have an HbA1c> 7% and 6% and 7% and 85% of the study drug during the simple blind placebo transition period (according to the tablet / capsule count). • The patient complies with the diet, exercises and other transition treatments during the transition period.
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. • The patient is in a weight loss program and is not in the maintenance phase (defined as a weight loss of 5 years without information about remission / cure. • The patient has undergone a surgical procedure within 1 month prior to signing the informed consent or plans to undergo major surgery. • In patient is under treatment for hyperthyroidism. • The patient is pregnant, has a pregnancy test with a positive result in Visit 1, expects to conceive within the projected duration of the study or is breastfeeding. • The patient hopes to donate eggs within the projected duration of the study. • The patient has been diagnosed with HIV (according to the medical history evaluation). • The patient has a current history or evidence of any condition, therapy, laboratory abnormality or other circumstance that, in the opinion of the researcher or Merck´s medical monitor, may pose a risk to the patient or cause the patient´s involvement not to be the most convenient, that could confuse the results of the study or interfere with the participation of the patient throughout the study. • The patient is unlikely to comply with study procedures, keep appointments or plan to move during the study. • The patient currently uses, has used within 3 months prior to signing the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of HbA1c values during the study. Measure:Change from baseline in HbA1c in Week 54 Timepoints:Week 54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Record of hypoglycaemic events during the study Measure:Incidence index of hypoglycaemic events up to Week 54 Timepoints:Week 54 ; Outcome name:Measurement of PPG, insulin and proinsulin levels Measure:Change from baseline in PPG, insulin and proinsulin Timepoints:Week 54 ; Outcome name:Measurement of blood pressure during the study. Measure:Change from baseline in blood pressure Timepoints:Week 54 ; Outcome name:Measurement of low density lipoprotein cholesterol levels [LDL-C], high density lipoprotein cholesterol [HDL-C], and triglycerides [TG] of the lipid panel during the study. Measure:Percentage change with respect to baseline in lipidic endpoints Timepoints:Week 54 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed