Status:
COMPLETED
Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.
Detailed Description
SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme in...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Diagnosis of type 2 diabetes
- 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.
- Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
- Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
- Fasting plasma glucose less than 13.3 mmol per L.
- Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.
- Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
- Body mass index greater than 23 kg/m2 and less than 45 kg/m2.
- If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
- Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.
- Exclusion Criteria
- History of type 1 diabetes.
- History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
- Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
- History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
- Hemoglobin less than 120 g per L for males and less than100 g per L for females.
- Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
- Serum creatinine level greater than 133 μmol per L.
- Fasting total cholesterol greater than 6.5 mmol per L.
- New York Heart Association heart failure of any Class (I-IV) regardless of therapy.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
- History of acute metabolic diabetic complications.
- History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- History of infection with human immunodeficiency virus.
- History of diabetic gastro paresis.
- History of gastric bypass surgery.
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00655863
Start Date
July 1 2007
End Date
December 1 2009
Last Update
May 27 2013
Active Locations (2)
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1
Amsterdam, Netherlands
2
Gothenburg, Sweden