Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00286442

Run by

Takeda

People needed

527

Starts

2006-03-01

Expected to finish

2007-06-01

Last updated by the study team

2012-02-03

Who can join

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

You may qualify if…

• 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

Where it is running

• Study site — Anaheim, California, United States
• Study site — Artesia, California, United States
• Study site — Fresno, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Northridge, California, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Cocoa Beach, Florida, United States
• Study site — Longwood, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Ocoee, Florida, United States
• Study site — Saint Cloud, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Avon, Indiana, United States
• Study site — Elkhart, Indiana, United States
• Study site — Evansville, Indiana, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Berlin, New Jersey, United States
• Study site — Burlington, North Carolina, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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