Status:
COMPLETED
Efficacy of Alogliptin With Pioglitazone (Actos®) 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 combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exerci...
Detailed Description
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% is type 2. The prevalence of type 2 diabetes varies among racial and ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Historical diagnosis of type 2 diabetes.
- Failed treatment with diet and exercise for at least 2 months prior to Screening.
- Is experiencing inadequate glycemic control as defined as glycosylated hemoglobin concentration between 7.5-11%, inclusive.
- Has received any antidiabetic therapy for less than 7 days within 3 months prior to Screening.
- Has a body mass index greater than or equal to 23 kg/m2 and less than or equal to45 kg/m2.
- Fasting C-peptide greater than or equal to 0.8 ng per mL.
- Regular use of other, non-excluded medications is allowed if participant is on a stable dose for at least 4 weeks prior to Screening.
- 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.
- Must be willing and able to monitor their blood concentrations with a home glucose monitor.
- Exclusion Criteria
- Systolic blood pressure greater than or equal to 160 mmHg and diastolic blood pressure greater than or equal to 100 mmHg.
- Hemoglobin 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 greater than or equal to 2.5times the upper limit of normal.
- Serum creatinine greater than 2.0 mg per dL.
- Thyroid stimulating hormone level greater than the upper limit of normal range.
- Major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
- Urine albumin to creatinine ratio of greater than 1000 ug 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
- History of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
- History of gastroparesis.
- Has New York Heart Association Class I to IV heart failure regardless of therapy.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 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 participant's ability to participate in the study.
- History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
- Any alteration in angiotensin-II receptor inhibitors within 2 months prior to Randomization, if applicable.
- History of alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day) or substance abuse (defined as illicit drug use) within 2 years prior to Screening.
- Received any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening.
- Previously participated in an investigational study of SYR-322.
- Glycosylated hemoglobin concentration between 7.5-11%, inclusive, and a fasting plasma glucose less than 310 mg per dL.
- At least 75% compliant with the single-blind placebo regimen during the run-in/stabilization period.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
655 Patients enrolled
Trial Details
Trial ID
NCT00395512
Start Date
November 1 2006
End Date
February 1 2008
Last Update
March 27 2013
Active Locations (161)
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1
Columbiana, Alabama, United States
2
Hueytown, Alabama, United States
3
Huntsville, Alabama, United States
4
Northport, Alabama, United States