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Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

NCT00286494•Takeda

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone 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 ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes. The aim of the current study is to evaluate the efficacy of alogliptin in combination with pioglitazone in subjects who are inadequately controlled on a thiazolidinedione (pioglitazone or rosiglitazone) alone or in combination with metformin or a sulfonylurea. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of type 2 diabetes mellitus currently treated with a thiazolidinedione either alone or in combination with metformin or a sulfonylurea but who are experiencing inadequate glycemic control. The subject should have received the thiazolidinedione therapy (rosiglitazone or pioglitazone) either alone or in combination with metformin or a sulfonylurea for at least the 3 months prior to Screening and must have been on a stable dose for all their antidiabetic treatments for at least the month prior to Screening.
•No treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject 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 subject 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 to10 g per dL for females.
•Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
•Serum creatinine less than or equal to 2.0 mg per dL.
+6 more criteria

Exclusion Criteria

•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. (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 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 the subject's ability to participate in the study.
•History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
+7 more criteria

Locations (77)

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Anaheim, California, United States

Artesia, California, United States

Fresno, California, United States

Mission Viejo, California, United States

Northridge, California, United States

Orange, California, United States

San Diego, California, United States

Walnut Creek, California, United States

Key Dates

Start Date

February 1, 2006

Primary Completion Date

August 1, 2007

Completion Date

August 1, 2007

Last Updated

February 3, 2012

Enrollment

493

ACTUAL participants

Conditions

Diabetes Mellitus

Interventions

Alogliptin and pioglitazone

DRUG

Alogliptin and pioglitazone

DRUG

Pioglitazone

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

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