Status:
COMPLETED
Efficacy and Safety of Alogliptin Combined With Metformin in Participants 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 metformin 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 metformin alone but, experiencing inadequate glycemic control. The participant should have received the metformin monotherapy for at least the 3 months prior to Screening; and must have a stable dose of greater than or equal to 1500 mg metformin for at least 8 weeks prior to randomization. Participants with a maximum tolerated dose that is documented to be less than 1500 mg of metformin may also be enrolled if this dose has been stable for 8 weeks prior to randomization.
- No treatment with antidiabetic agents other than metformin within the 3 months prior to Screening. (Exception: if a participant 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 per mL. (If this screening criterion is not met, the participant still qualifies if C-peptide is greater than or equal to 1.5 ng per 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 to 180 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 less than1.5 mg per dL for males and less than 1.4 mg per dL for females
- Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the participant is clinically euthyroid.
- Neither pregnant nor lactating.
- Female participants 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 participant 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 participant 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 participants 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 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
- 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:
- Treatment with antidiabetic agents other than study drug or metformin 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, 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.
- Participants must be instructed not to take any medications, including over-the-counter products, without first consulting with the investigator.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT00286442
Start Date
March 1 2006
End Date
June 1 2007
Last Update
February 3 2012
Active Locations (56)
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1
Phoenix, Arizona, United States
2
Anaheim, California, United States
3
Artesia, California, United States
4
Fresno, California, United States