OPEN STUDY PHASE IIIA PROLONGED ON THE SAFETY OF ORAL ADMINISTRATION OF 32 MG TAK-559 (QD) IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS TYPE 2
- Conditions
- -E119 Non-insulin-dependent diabetes mellitus, without complicationsNon-insulin-dependent diabetes mellitus, without complicationsE119
- Registration Number
- PER-063-04
- Lead Sponsor
- TAKEDA PHARMACEUTICALS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Patients who have signed the informed consent before the inclusion evaluations are made.
• Male or female patients> 25 years of age at the time of inclusion. Patients> 80 years of age require TGRD approval.
• Patients who have participated in Protocol 01-02-TL-559-013 or 01-02-TL-559- 014 and have completed it, have prematurely terminated the same due to the criterion of withdrawal from the study about the HbA1c level after at least 12 weeks of treatment, or at the investigator´s discretion, the patient demonstrated a lack of efficacy after at least 16 weeks of treatment and will be removed from Protocol 01-02-TL-559-013 or 01 -02-TL-559-014. Patients who have been withdrawn from Protocols 01-02-TL-559-013 or 01-02-TL-559-014 due to lack of efficacy after at least 16 weeks of treatment will require the approval of the sponsor to enter to Protocol 01-03-TL-559-017.
• Post-menopausal women (defined as 2 years without menstrual cycles at least), surgically sterile or using an adequate contraceptive method (suitable contraceptive methods are: hormonal contraceptives, double barrier methods and / or intrauterine devices; contraceptive methods NOT acceptable are: abstinence, vasectomy and stereotyping of the couple), that are not breastfeeding and women of childbearing age whose pregnancy test has had a negative result in the inclusion and before receiving the first dose of the medication study.
• Patients willing to continue carrying out an individualized diet to maintain weight during the study period.
• Patients with evidence of ability to secrete insulin, demonstrated by a fasting C-peptide concentration> 1.5 ng / ml (0.50 nmol / 1) in the previous visit of Protocol 01-02-TL-559-013 or 01-02-TL-559-014.
• Patients willing to perform daily self-monitoring of blood glucose level (SMBG).
• Patients in good health at the time of inclusion, determined by a doctor at the final visit of Protocol 01-02-TL-559-013 or 01-02-TL-559-014 (that is, through the clinical history and physical examination), in addition to type 2 diabetes mellitus and congestive heart failure (CCI) category I according to the New York Heart Association (NYHA) classification (if applicable) .
• Patients whose clinical laboratory evaluations (which include serum chemistry, hematology, and complete urinalysis after a minimum of 8 hours of fasting) are within the normal reference range for laboratory analyzes unless the investigator or the sponsor consider that the results are not clinically significant in the previous visit of Protocol 01-02-TL-559-013 or 01-02-TL-559-014.
• Patients with a normal level of thyroid stimulating hormone (TSH) less than 5.5 mlU / ml (5.5 mIU / 1) and greater than or equal to 0.35 ulU / ml (0.35 mIU / 1) in the previous visit of Protocol 01-02-TL-559-013 or 01-02-TL-559-014. If the patient´s TSH level is higher than 5.5 ulU / ml (5.5 mIU / 1), the level of free T4 can be determined. If the level of free T4 is within the normal limits of that patient, the patient can remain in the study.
• Patients with significant cardiovascular disease including, without limitation, a category III or IV CHF according to the NYHA classification at the time of inclusion.
• Patients who plan to undergo surgery or a coronary angioplasty catheterization within 12 months after the Inclusion visit.
• Patients with a systolic blood pressure (SBP)> 140 mm Hg or a diastolic blood pressure> 95 mm Hg at the time of inclusion.
• Patients with symptomatic orthostatic hypotension or SBP <90 mm Hg at the time of inclusion.
• Patients with a history of a clinically significant abnormal ECG or who have experienced a cardiovascular event including without limitation myocardial infarction, coronary angioplasty or aortocoronary bypass, unstable angina pectoris, transient ischemic attacks or stroke registered during the Protocols 01- 02-TL -559-013 or 01-02-TL-559-014.
• Patients with a CPK value of> 3 times higher than the upper limit of the normal range (LSN) in the previous visit of Protocol 01-02-TL-559-013 or 01-02-TL-559-014.
• Patients with a triglyceride value> 500 mg / dl (5.6 nmol / 1) in the previous visit of Protocol 01-02-TL-559-013 or 01-02-11 ^ 559-014.
• Patients who have had a level of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 3 greater than the ULN, active liver disease or hepatitis at any time during Protocol 01-02-TL-559-013 or 01-02 -TL-559-014.
• Patients who do not wish or can not comply with the requirements of the protocol, diet or scheduled visits.
• Pregnant patients, who wish to become pregnant during the course of the study or who are breastfeeding.
• Patients who have donated and / or received blood products within 3 months prior to inclusion.
• Patient who have used illicit drugs or abused alcohol (defined as regular or daily consumption of more than 4 alcoholic beverages per day) while participating in Protocol 01-02-TL-559-013 or 01-02-TL -559-014.
• Patients who have experienced intercurrent illnesses that required admission during the 3 weeks prior to the Inclusion visit.
• Patients who have experienced any other illness or serious condition while participating in Protocol 01-02-TL-559-013 or 01-02-TL-559-014, which could affect life expectancy or hinder the correct management and Patient follow-up according to the protocol.
• Patients who have experienced persistent microscopic or macroscopic unexplained hematuria or who have developed bladder cancer while participating in Protocol 01-02-TL-559-013 or 01-02-TL-559-014.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Measured according to clinical laboratory tests, physical exams, vital signs, ECGs and the presence of adverse events.<br>Measure:Safety<br>Timepoints:During the study<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Glycemic control, measured as a function of the changes observed from the baseline condition (Month 0) in the level of glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), fasting insulin and fasting C-peptide.<br>Measure:Glycemic control<br>Timepoints:Months 6, 12, 18, and Final Visit<br>;<br>Outcome name:The serum level of lipids: triglycerides (TG), total cholesterol, high density lipoproteins (HDL), low density lipoproteins (LDL) [LDL fraction] and very low density lipoproteins (VLDL).<br>Measure:Serum level of lipids<br>Timepoints:Months 6, 12, 18, and Final Visit<br>;<br>Outcome name:Markers of inflammation / atherosclerosis including interleukin-6 (IL-6), fibrinogen, C-reactive protein (CRP), IAP-1.<br>Measure:Markers of inflammation / atherosclerosis<br>Timepoints:Months 6, 12, 18, and Final Visit<br>