Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.

Key facts

Study ID

NCT00286429

Run by

Takeda

People needed

390

Starts

2006-02-01

Expected to finish

2007-05-01

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 and currently treated with insulin alone (with or without metformin), and is inadequately controlled. Metformin dose must be stable for at least 8 weeks prior to Randomization.
• No treatment with antidiabetic agents other than insulin and metformin within the 8 weeks prior to Randomization.
• 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 subject still qualifies if C-peptide greater than or equal to 1.5 ng per mL after a challenge test).
• Glycosylated hemoglobin concentration greater than or equal to 8.0% at Screening.
• Using a stable dose of insulin of at least 15 units but not more than 100 units per day for at least 8 weeks prior to Randomization. A dose of insulin that varies by up to 15% of the mean will be considered as stable.
• 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 to180 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 to10 g per dL for females.
• Alanine aminotransferase less than or equal to 3 times the upper limit of normal.
• Serum creatinine less than or equal to 2.0 mg per dL.
• Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.
• Neither pregnant (confirmed by laboratory testing in females of childbearing potential) nor lactating.
• Female subjects 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 own blood glucose concentrations with a home glucose monitor
• No major illness or debility that in the investigator's opinion prohibits the individual from completing the study
• Able and willing to provide written informed consent

You may not qualify if…

• Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject 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. (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 subjects 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 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 insulin and metformin is not allowed within the 8 weeks prior to Randomization and through the completion of the end-of treatment or early termination procedures. (Exception: if has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
• 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 or early termination procedures. Inhaled corticosteroids are allowed.
• Must not take any medications, including over-the-counter products, without first consulting with the investigator.

Where it is running

• Study site — Anaheim, California, United States
• Study site — Artesia, California, United States
• Study site — Fresno, 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 — Tustin, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Denver, Colorado, United States
• Study site — Cocoa Beach, Florida, United States
• Study site — Longwood, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Saint Cloud, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Lawrenceville, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Avon, Indiana, United States
• Study site — Evansville, Indiana, United States
• Study site — Lafayette, 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 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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