Efficacy and Safety of TAK-379 in Adult Subjects With Type 2 Diabetes Mellitus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to evaluate the safety and effectiveness of multiple doses of TAK-379, once daily (QD), in subjects with type 2 diabetes mellitus.

Key facts

Study ID

NCT00722917

Run by

Takeda

People needed

323

Starts

2008-07-01

Expected to finish

2009-04-01

Last updated by the study team

2016-06-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Historical diagnosis of type 2 diabetes mellitus without the chronic use of antidiabetic therapy and an 8 week history of diet and exercise.
• Historical diagnosis of type 2 diabetes mellitus on a stable dose of metformin as mono-therapy for at least 3 months prior to screening.
• Glycosylated hemoglobin between 7.5% and 10.0%, inclusive.
• Fasting C-peptide concentration is greater than or equal to 0.8 ng per mL.
• Any other chronic medications which have been stable for at least 4 weeks prior to Screening.
• Body mass index at Screening is greater than or equal to 23 kg/m2 and less than 45 kg/m2.
• Able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Compliance with single-blinded study medication during the run-in phase is at least 75% and does not exceed 125% based on tablet counts performed by the study staff.

You may not qualify if…

• Systolic blood pressure is greater than 160 mm Hg, or diastolic pressure is greater than 100 mm Hg at repeat measurements.
• Any history of bladder cancer or has a history of cancer that has been in remission for less than 5 years prior to Screening (a history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed).
• Glycosylated hemoglobin is less than 7.5% and greater than 10.0%.
• Creatine phosphokinase is greater than or equal to 5 times the upper limit of normal at screening.
• Hemoglobin is less than or equal to 12 g per dL for males and less than or equal to 10 g per dL for females.
• Alanine aminotransferase and aspartate aminotransferase are greater than or equal to 2.5 upper limit of normal.
• Total bilirubin is greater than or equal to 1.5 times the upper limit of normal at screening.
• Serum triglyceride concentration is greater than or equal to 400 mg per dL.
• Estimated glomerular filtration rate is less than or equal to 60 mL per min using the Modification of Diet in Renal Disease equation or the Cockroft-Gault equation.
• Abnormal thyroid-stimulating hormone as defined by central laboratory normals.
• Positive test result for hepatitis B surface antigen or hepatitis C antibody.
• Urine albumin to creatinine ratio is greater than or equal to 1000 μg per mg at screening.
• History of microscopic or macroscopic hematuria.
• Two consecutive unexplained positive urinalysis dip-stick and greater than or equal to 3 red blood cells per high-powered field on two consecutive measurements.
• History of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• Diabetic gastroparesis that in the investigator's opinion is moderate or severe and hence may impair absorption of study medication.
• The subject has New York Heart Association Class III or IV heart failure.
• Has had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram, cerebrovascular accident or transient ischemic attack within 6 months prior or at Screening.
• History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
• Received treatment with probucol within 1 year of randomization.
• Donated or received any blood products within 12 weeks prior to Screening.
• Received treatment for greater than 7 days within 8 weeks prior to randomization or is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• oral or systemically injected glucocorticoids
• Prescription or over the counter weight-loss drugs
• Peroxisome proliferator-activated receptor agonists, including fibric acid derivatives

Where it is running

• Study site — Artesia, California, United States
• Study site — Norwalk, California, United States
• Study site — Santa Ana, California, United States
• Study site — Santa Monica, California, United States
• Study site — Panama City, Florida, United States
• Study site — Cranston, Rhode Island, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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