Status:
COMPLETED
Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin...
Detailed Description
Of the approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2 diabetes mellitus varies ...
Eligibility Criteria
Inclusion
- Has type 2 diabetes mellitus and were either receiving no current treatment or currently treated with a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin but experiencing inadequate glycemic control. Subjects qualified as receiving no current treatment if 1 of the following conditions applied:
- Subject was newly diagnosed (ie, had not received any treatment).
- Subject was treated with diet and exercise alone for the 3 months prior to Screening
- Subject had received \<7 continuous days of any antidiabetic therapy within the 3 months prior to Screening.
- Subject had a diagnosis of type 2 diabetes mellitus based on current American Diabetes Association criteria: fasting plasma glucose ≥126 mg/dL, oral glucose tolerance test at 2 hours after administration of the glucose load must have been ≥200 mg/dL, or symptoms of diabetes plus casual plasma glucose ≥200 mg/dL.
- Body mass index ≥23 kg/m2 and ≤40 kg/m2.
- Fasting C-peptide concentration ≥0.8 ng/mL.
- Glycosylated hemoglobin concentration between 6.8% and 11.0%.
- Fasting plasma glucose \>126 mg/dL at Screening.
- No treatment within the 3 months prior to Screening with any other agents known to have effects on glucose (other than as described above, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin in subjects on antidiabetics), including but not limited to the following:
- Other antidiabetic agents
- Investigational antidiabetic agents
- Niacin
- Regular use of systemic glucocorticoids.
- No treatment within the 3 months prior to Screening with weight-loss drugs
- If taking other non-excluded medications, must have been on a stable dose of medication for at least 4 weeks.
- Diastolic blood pressure ≤110 mm Hg and a systolic pressure of ≤180 mm Hg.
- Female subjects could neither be pregnant (confirmed by laboratory testing) nor lactating, and if of childbearing potential must have been practicing adequate contraception.
- 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 prohibited the subject from completing the study.
- Hemoglobin ≥12 g/dL for males and ≥10 g/dL for females.
- Hepatic transaminase ≤2 x upper limit of normal.
Exclusion
- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 1 year prior to Screening.
- History of proteinuria \>1000 mg/day on a 12- or 24-hour urine collection OR a urine albumin/creatinine ratio \>1000 μg/mg at Screening. If elevated, the subject was to be rescreened within 1 week.
- Serum creatinine ≥2.0 mg/dL.
- History of proliferative diabetic retinopathy OR any history of laser-treated retinopathy.
- History of treated peripheral or autonomic neuropathy.
- History of systolic dysfunction congestive heart failure.
- History of myocardial infarction within 1 year prior to Screening.
- History of ulcerative colitis or Crohn's disease.
- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- History of a psychiatric disorder that would affect the subject's ability to participate in the study.
- History of anaphylactic reaction(s) to any drug.
- History of angioedema.
- History of alcohol or substance abuse within the last 2 years.
- History of any surgery that could potentially affect the absorption of the study drug.
- Receipt of any investigational drug within the preceding 30 days or a history of receipt of an investigational antidiabetic drug within the preceding 90 days.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00755846
Start Date
March 1 2005
End Date
October 1 2005
Last Update
February 3 2012
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