Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.

Key facts

Study ID

NCT01023581

Run by

Takeda

People needed

784

Starts

2009-11-01

Expected to finish

2011-06-01

Last updated by the study team

2013-03-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has historical diagnosis of Type 2 Diabetes Mellitus.
• Has been treated with diet and exercise for at least 2 months prior to Screening, and has a Glycosylated Hemoglobin concentration between 7.5% and 10.0%, inclusive at Screening.
• Has received less than 7 days of any antidiabetic medication within 2 months prior to Screening.
• Body mass index greater than or equal to 23 kg/m\^2 and less than or equal to 45 kg/m\^2 (except for Asian or Asian-descendant subjects for whom the range is between 20 and 35 kg/ m\^2, inclusive).
• Fasting C-peptide concentration greater than or equal to 0.8 ng/mL.
• Regularly using other, non-excluded, medications must be on a stable dose for at least the 4 weeks prior to Screening.
• Females of childbearing potential and males who are sexually active agree to routinely use adequate contraception from Screening throughout the duration of the study.
• Able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete patient diaries.

You may not qualify if…

• Hemoglobin less than 12 g/dL for males and less than 10 g/dL for females at Screening Visit.
• Has a history of any hemoglobinopathy that may affect determination of Glycosylated Hemoglobin.
• Has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
• Has a history of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
• Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
• Has systolic blood pressure greater than or equal to 150 mmHg and /or diastolic pressure greater than or equal to 90 mmHg at Screening visit.
• Has New York Heart Association Class III to IV heart failure.
• Has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 90 days prior to Screening.
• Has Alanine aminotransferase greater than 3 times the upper limit of normal at Screening.
• Has a history of alcohol or substance abuse with the 2 years prior to Screening.
• Serum creatinine greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.4 mg/dL for females.
• Has 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.
• Has a history of infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus.
• Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
• Has received any investigational drug within the 90 days prior to Screening.
• Has a history of hypersensitivity or allergy to alogliptin, other DPP-4 inhibitors, metformin or related compounds.
• Has used oral or systematically injected glucocorticoids or weight loss drugs prior to 2 months to screening.

Where it is running

• Study site — Muscle Shoals, Alabama, United States
• Study site — Pell City, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Searcy, Arkansas, United States
• Study site — Tempe, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Buena Park, California, United States
• Study site — Cathedral City, California, United States
• Study site — National City, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Roseville, California, United States
• Study site — Santa Ana, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Boca Raton, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Cutler Bay, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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