Status:
COMPLETED
Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.
Detailed Description
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Diagnosis of type 2 diabetes mellitus , currently treated with a sulfonylurea alone but experiencing inadequate glycemic control. Should have received the sulfonylurea monotherapy for at least the 3 months prior to Screening; has been on a stable sulfonylurea dose equivalent to at least 10 mg of glyburide (Exception: documented maximum tolerated dose equivalent to less than 10 mg but at least 5 mg glyburide) for at least 8 weeks.
- No treatment with antidiabetic agents other than a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
- Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
- Fasting C-peptide concentration greater than or equal to 0.8 ng/mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng/mL after a challenge test.).
- Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive.
- If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
- Systolic blood pressure less than or equal to180 mm Hg and diastolic pressure less than or equal to 110 mm Hg
- Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to 10 g per dL for females
- Alanine aminotransferase less than or equal to 3 time the upper limit of normal.
- Serum creatinine ≤2.0 mg/dL (≤17 micromol/L)
- Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.
- Neither pregnant nor lactating
- Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study.
- Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
- No major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
- Able and willing to provide written informed consent
- Exclusion Criteria
- Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.
- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)
- History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- History of treated diabetic gastric paresis.
- New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
- History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- History of a psychiatric disorder that will affect the subject's ability to participate in the study.
- History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
- History of alcohol or substance abuse within the 2 years prior to Screening.
- Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.
- Prior treatment in an investigational study of alogliptin.
- Excluded Medications and Treatments:
- Treatment with antidiabetic agents other than study drug or glyburide is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures.
- Treatment with weight-loss drugs, any investigational antidiabetics, Bosentan (used for the treatment of pulmonary hypertension), or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of- treatment/early termination procedures. Inhaled corticosteroids are allowed.
- Subjects must not take any medications, including over-the-counter products, without first consulting with the investigator.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00286468
Start Date
April 1 2006
End Date
June 1 2007
Last Update
February 3 2012
Active Locations (68)
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Birmingham, Alabama, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Anaheim, California, United States