A MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SITAGLIPTINE AGAINST GLIPIZIDE IN PATIENTS WITH DIABETES MELLITUS TYPE 2 AND TERMINAL PHASE NEPHROPATHY THAT ARE SUBJECTED TO DIALYSIS AND HAVE AN INAPPROPRIATE GLYCEMIC CONTRO
- Conditions
- -E10 Insulin-dependent diabetes mellitus-E14 Unspecified diabetes mellitusInsulin-dependent diabetes mellitusUnspecified diabetes mellitusE10E14
- Registration Number
- PER-038-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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 <9%. The patient is in one of the following 2 categories and according to the review of the current diet, the patient´s medical regime and HbA1c at Visit 1, the researcher considers that the patient possibly meets the inclusion criteria of Visit 4 / Week -2 of HbA1c> 7% and <9%;
• The patient is not currently in therapy with antihyperglycemic agents (without therapy> 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 <9% at two weeks or within two weeks prior to Visit 4 / Week -2.
• The patient is currently on monotherapy with antihyperglycemic agents (or low dose oral combination therapy [ie <50% of the maximum tolerated dose of each agent]) and has an HbA1c> 6% and <9% in the Visit 1
• HbA1c> 7% and <9% measured on or within 2 weeks before Visit 4 / Week -2.
• The patient has a compliance of> 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.
• 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 <2 kg in 2 months).
• The patient intends to participate in a weight reduction intervention not prescribed in the study.
• The patient is, at the time of signing the informed consent, a user of recreational or illicit drugs or has presented a recent history (within the last year) of drug or alcohol abuse or dependence.
• The patient has a clinically important hematologic disorder (eg, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
• The patient has cirrhosis or an active liver disease (other than fatty liver), a chronic progressive neuromuscular disorder (for example, multiple sclerosis or polymyositis) or has any other condition or therapy that, in the opinion of the researcher or medical monitor of Merck, could put the patient at risk or make the patient´s participation not what is best for him.
• The patient has undergone dialysis for <6 months.
• The patient does not regularly comply with the prescription on dialysis.
• The patient has been diagnosed with a significant cardiovascular disorder (eg, MI or unstable angina) or has undergone a cardiovascular procedure (eg, CABG or PTCA) within 3 months of signing the informed consent.
• The patient presents with new or worsening signs or symptoms of congestive heart failure within 3 months of signing the informed consent (See Appendix 6.6.).
• The patient has an active peripheral vascular disease (for example, manifested by claudication with normal activity, an ischemic ulcer that does not heal or a disease that probably requires an intervention such as a bypass or angioplasty).
• The patient presents a recent diagnosis / episode / recurrence (within 3 months prior to signing the informed consent) of stroke, TIA, or neurological disorder, including, but not limited to, seizures, fainting, or a recent change within of the 3 months prior to signing the informed consent) in the dose or class of drugs used to treat these conditions.
• The patient has a history of malignancy <5 years before signing the informed consent, or> 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Measurement of HbA1c values during the study.<br>Measure:Change from baseline in HbA1c in Week 54<br>Timepoints:Week 54<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Record of hypoglycaemic events during the study<br>Measure:Incidence index of hypoglycaemic events up to Week 54<br>Timepoints:Week 54<br>;<br>Outcome name:Measurement of PPG, insulin and proinsulin levels<br>Measure:Change from baseline in PPG, insulin and proinsulin<br>Timepoints:Week 54<br>;<br>Outcome name:Measurement of blood pressure during the study.<br>Measure:Change from baseline in blood pressure<br>Timepoints:Week 54<br>;<br>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.<br>Measure:Percentage change with respect to baseline in lipidic endpoints<br>Timepoints:Week 54<br>