None listed
Conditions
Interventions
Group 1 Type of group
Glipizide will be administered at an initial dose of 2.5 mg (1/2 tablet, slotted) once a day in the morning before breakfast. The dose of glipizide (or placebo of glipizide) will be adjusted electively to a maximum dose of 4 tablets per day (2 tablets b.i.d., providing 10 mg b.i.d. to patients in the treatment group with glipizide). For 54 weeks.
Group name:Group 2 Type of group
Patients with moderate renal impairment will receive 2 tablets / day of sitagliptin at a dose of 25 mg or the corresponding placebo, and patients with severe renal insufficiency will receive 1 tablet / day of sitagliptin at a dose of 25 mg or the corresponding placebo. For 54 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient has type 2 diabetes mellitus (T2DM). • The patient has moderate or severe renal insufficiency as indicated by an estimated glomerular filtration rate (eGFR) 30 years old on the day of signing the informed consent. • The patient is a man. • The patient is a woman surgically sterilized. • The patient is a postmenopausal woman> 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 having heterosexual activity or using 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 seems to be able to complete the study. • The patient is not currently receiving an antihyperglycemic agent (without therapy for> 12 weeks) and has an HbA1c> 7% and 7% to 12 weeks), has an HbA1c> 9% at Visit 1, and after a period of diet and exercise, probably has an HbA1c> 7% and 6.5% and 7% and 85% with respect to the study drug during the simple blind placebo transition (as determined by the tablet / capsule count). • The patient complies with the diet, exercises and other treatments of the transition 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 losing weight in a weight loss program and is not in the maintenance phase (defined as 2 drinks per day or> 14 drinks per week, or rampant alcohol consumption in a short period of time. • The patient has a clinically important hematologic disorder (eg, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia). • The patient has cirrhosis or active liver disease (different from hepatic steatosis), chronic progressive neuromuscular disorder (for example, multiple sclerosis or polymyositis), or any other condition or therapy that, in the opinion of the researcher or Merck´s medical monitor, could put it at risk or make their participation not the most convenient for him. • The patient has acute or rapidly progressive nephropathy, or has a history of kidney transplantation. • The patient is on dialysis or seems to need to start receiving dialysis during the course of the study. • The patient has been diagnosed with a significant cardiovascular disorder (eg, MI or unstable angina) or has undergone cardiovascular surgery (eg, CABG or PTCA) within 3 months of signing the informed consent. • The patient presents new signs or symptoms of congestive heart failure, or worsening thereof, within 3 months of signing the informed consent (see Appendix 6.6). • The patient suffers from a severe active 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 has recently had (within 3 months prior to signing the informed consent) a diagnosis / episode / recurrence of stroke, TIA or neurological disorder, including, without limitation, seizures, fainting, or a recent change ( within 3 months prior to signing the informed consent) in the dose or class of drug used to treat these conditions. • The patient has a history of malignancy 5 years without documentation of remission / cure. • The patient has undergone surgery within 1 month before signing the informed consent or has planned major surgery. • The patient is pregnant, has a urine pregnancy test with 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 (as assessed by medical history). • The patient has a history or current evidence of a condition, therapy, laboratory abnormality or other circumstance that, in the opinion of the researcher or the Merck medical monitor, could pose a risk to the patient or make their participation not the most convenient for him, it could confuse the results of the study, or interfere with the patient´s participation throughout the study. • The patient is unlikely to stick
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of HbA1c during the study Measure:change with respect to the baseline in HbA1c Timepoints:Week 54 ; Outcome name:Record of hypoglycemic events by the researcher. Measure:Incidence rate of hypoglycemic events Timepoints:Week 54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of body weight during the study Measure:Change with respect to the basal body weight 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