PER-132-08
Completed
未知
A Phase II, Randomized, Double-Blind, Placebo-and Active-Controlled, Multi-center Study to Determine the Efficacy and Safety of TAK-379 in Subjects With Type 2 Diabetes
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject is a man or woman 18 to 80 years of age, inclusive, and meets one of the following criteria: A historical diagnosis of type 2 diabetes mellitus without chronic use (defined as\> 7 days) of antidiabetic treatment and history of 8 weeks of diet and exercise at the time of selection o A historical diagnosis of type 2 diabetes mellitus with a stable dose of metformin as monotherapy for at least 3 months before selection.
- •The subject has an HbA1c between 7\.5% and 10\.0%, inclusive
- •The subject has a fasting C\-peptide concentration\> 0\.8 ng / mL (0\.26 nmol / L).
- •The subject has other chronic medications that have been stable (no dose or medication changes) for at least 4 weeks before Selection,
- •The body mass index (BMI) of the subject at the time of Selection is\> 23 kg / m2 and \<45 kg / m2\.
- •The subject is able to understand and comply with the requirements of the protocol.
- •The subject or his legally authorized representative signs a written informed consent form before the start of any study procedure.
- •The subject is able and willing to monitor their own blood glucose concentrations with a homemade glucose monitor.
- •A female subject who is not pregnant or nursing. A female subject of childbearing age must have a pregnancy test using negative human chorionic gonadotropin (HCG) in the Selection and in Week \-1 before the administration of the first dose of the double\-blind study medication.
- •Women of childbearing age who are sexually active agree to use an appropriate contraceptive method from the selection and for the entire duration of the study and up to 1 month after the last dose of the study medication. Women who are NOT of childbearing age are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation) or who are postmenopausal (defined as at least 2 years since the last regular menstruation). Acceptable contraceptive methods are defined in Section 9\.1\.11 Procedure for Contraceptives and Pregnancy Prevention.
Exclusion Criteria
- •The subject´s systolic blood pressure is\> 160 mmHg or the diastolic blood pressure is\> 100 mmHg in repeated measurements.
- •The subject has a history of bladder cancer or a history of a cancer that has been in remission for \<5 years prior to Selection (the history of basal cell carcinoma or squamous cell carcinoma is allowed in Stage 1\).
- •The subject has an HbAlc \<7\.5% and\> 10\.0%.
- •Creatine phosphokinase (CPK)\> 5 x LNS in the selection.
- •The subject has a hemoglobin \<12 g / dL (120 gm / L) for men and \<10 g / dL (100 gm / L) for women.
- •The subject has a alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\> 2\.5 the upper normal limit (LNS).
- •The subject has a total bilirubin\> 1\.5 x LNS in the selection.
- •The subject has a serum triglyceride concentration\> 400 mg / dL (4\.5 mmoI / L),
- •The subject has an estimated glomerular filtration rate (VFG) \<60 mL / min using the Diet Modification equation in Kidney Disease (MDER) or the Cockroft\-Gauli equation.
- •The subject has an abnormal level of thyroid stimulating hormone (TSH) defined according to the normal values of the central laboratory.
Outcomes
Primary Outcomes
Not specified
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