Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of TAK-875 in Subjects With Type 2 Diabetes
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-68 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending-doses of TAK-875 in subjects with type 2 diabetes mellitus.
Detailed Description
TAK-875 is being developed as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Nonclinical data suggest that TAK-875 stimulates insulin secretion ...
Eligibility Criteria
Inclusion
- Participants with type 2 diabetes who are newly diagnosed, managed with diet and exercise alone, or taking up to 2 oral antidiabetic agents (except thiazolidinediones) and willing to discontinue the antidiabetic medication(s) 2 weeks prior to randomization.
- Meets one of the following glycosylated hemoglobin criteria (diagnosis must be based on current American Diabetes Association criteria) at Screening:
- If treatment naïve, should have a glycosylated hemoglobin concentration greater than or equal to 6.5% and less than or equal to 10.0%.
- If on a single antidiabetic agent (stable dose for at least 28 days), should have a glycosylated hemoglobin greater than or equal to 6% and less than or equal to 9.5%.
- If on a combination of up to 2 antidiabetic agents (stable doses for at least 28 days), should have a glycosylated hemoglobin greater than or equal to 6% and less than or equal to 9.0%.
- Has fasting plasma glucose greater than 126 mg/dL and less than 260 mg/dL if not on any antidiabetic medication, or less than 220 mg/dL if on any single antidiabetic agent, and less than 200 mg/dL if on any combination of 2 oral antidiabetic agents at Screening.
- Has fasting C-peptide concentration greater than or equal to 0.8 ng/mL at Screening.
- Weighs at least 50 kg (110 lb) and has a body mass index between 18 and 40 kg/m2, inclusive at Screening.
- Has not received treatment with weight-loss drugs within the 3 months prior to Screening.
- Has a systolic blood pressure less than or equal to 160 mm Hg and a diastolic blood pressure of less than or equal to 100 mm Hg at Screening and at Check-in (Day -2).
- Female participant is not of child-bearing potential (ie, surgically sterile \[hysterectomy, bilateral oophorectomy, or 2 years post-tubal ligation\] or postmenopausal \[2 years since last menses\]).
- Is able and willing to monitor blood glucose concentrations with a home glucose monitor during the Washout Interval and record results in the daily diary.
- Has negative test results at Screening and Check-in for selected substances of abuse, including alcohol and cotinine.
- Has Screening and Check-in clinical laboratory evaluations \[including fasting clinical chemistry, hematology, and complete urinalysis (excluding glucose results)\] within the reference range for the testing laboratory, unless the investigator deems the out-of-range results to be not clinically significant.
- Has negative test results for hepatitis B surface antigen and antibody to hepatitis C virus, and no known history of human immunodeficiency virus.
- Is willing to refrain from strenuous exercise from 72 hours before Check-in and throughout the study.
- Is considered by the investigator to be in a good health (other than being diabetic) as determined during the medical history review, physical examination findings, electrocardiogram and vital sign results, and clinical laboratory evaluations.
- Has creatinine clearance greater than 60 mL/min at Screening and Check-in.
Exclusion
- Has a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy), thoracic, or nonperipheral vascular surgery within 6 months prior to Check-in.
- Has a known hypersensitivity to TAK-875, or other related compounds.
- Has a history of cardiac arrhythmia, systolic dysfunction congestive heart failure, angina, myocardial ischemia or infarction, or stroke within 1 year prior to Screening, or the presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically significant.
- Has a history of drug abuse or a history of alcohol abuse within 2 years prior to Screening.
- Has used any tobacco (ie, nicotine) products within 90 days prior to Check-in, and is unwilling to abstain from these products for the duration of the study.
- Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. This criterion does not apply to basal cell or stage I squamous cell carcinoma of the skin.
- Has an alanine aminotransferase, alkaline phosphatase or aspartate aminotransferase level greater than or equal to 2 times the upper limit normal for the testing laboratory, active liver disease, or jaundice at Screening or Check-in.
- Has a total bilirubin greater than 2 mg/dL at Screening or Check-in.
- Has donated blood or experienced acute blood loss (including plasmapheresis) of greater than 500 mL within 90 days prior to the first dose of study drug.
- Participant is on any insulin treatment.
- The subject has a history of proteinuria greater than 300 mg/day on a 12- or 24-hour urine collection or an albumin/creatinine ratio greater than 300 μg/mg at Screening. If elevated, the subject may be rescreened within 1 week, and may be included in study with agreement between Principal Investigator and the Takeda Global Research and Development Medical Monitor.
- Has a history of any clinically significant retinopathy, which is defined as more than moderate nonproliferative diabetic retinopathy or any stage of proliferative diabetic retinopathy or any history of laser-treated retinopathy.
- Has history of treated or clinically significant peripheral or autonomic neuropathy.
- The subject has a history of ulcerative colitis or Crohn's disease, or has undergone gastric resection.
- The subject has a history of a psychiatric disorder that will affect the subject's ability to participate in the study.
- Has a history of angioedema.
- Had an acute, clinically significant illness within 30 days prior to Check-in, or any other condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.
- Participant took or requires the use of any restricted medication or products within the timeframes listed.
- Is participating in another investigational study or has taken any investigational drug within 30 days prior to Check-in.
- Has poor venous access.
- Has been randomized in a previous TAK-875 study within 6 months prior to the first dose of study drug.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00949091
Start Date
January 1 2009
End Date
July 1 2009
Last Update
June 11 2010
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