Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Subjects With Type 2 Diabetes Mellitus

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Alogliptin and metformin (Drug); Alogliptin and metformin (Drug); Glipizide and metformin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
Vice President Biological Sciences, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.

Overall contact:
Takeda Study Registration Call Center, Phone: 800-778-2860, Email: medicalinformation@tpna.com

The purpose of this study is to determine the safety and effectiveness of adding alogliptin compared to glipizide with metformin in diabetic subjects.

Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from Baseline in Glycosylated Hemoglobin.

Secondary outcome:

Change from Baseline in Glycosylated Hemoglobin.

Change from Baseline in Fasting Plasma Glucose.

Incidence of Glycosylated Hemoglobin less than or equal to 6.5%

Incidence of Glycosylated Hemoglobin less than to 7.0%

Change from Baseline in Body Weight

Detailed description: For patients diagnosed with type 2 diabetes mellitus, metformin is the usual first-line therapy in addition to diet control and exercise. For those patients with inadequate glycemic control with metformin monotherapy or experiencing serious side effects of metformin, sulfonylurea is a popular choice as a second-line oral antidiabetic treatment.

Alogliptin is a dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus.

This study is designed to further explore the durability of efficacy and safety of alogliptin compared to glipizide in type 2 diabetes mellitus subjects whose blood sugar level is inadequately controlled with metformin therapy.

The duration of this study will be approximately 2 years.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Has a diagnosis of type 2 diabetes mellitus.

- Must be inadequately controlled on a stable daily dose of ≥1500 mg (or documented

maximum tolerated dose) of metformin for at least 2 months prior to Screening.

- No treatment with antidiabetic agents other than metformin for 2 months prior to

Screening.

- Has body mass index within 23kg/m2 and 45kg/m2.

- Has fasting C-peptide concentration at least 0. 8 ng.

- If regularly using non-excluded medications, must be on a stable dose at least 4 wks

prior to screening.

- Females of childbearing potential who are sexually active must agree to use adequate

contraception, and can neither be pregnant, lactating or intends to donate ova from Screening throughout the duration of the study.

- Must be able and willing to monitor their blood glucose concentrations with a home

monitor, and comply with protocol requirements including scheduled clinic appointments.

Exclusion Criteria:

- Systolic blood pressure greater than or equal to 150 mmHg and/or diastolic pressure

greater than or equal to 90.

- Hemoglobin less than or equal to 12 g/dL for males and less than or equal to 10 g/dL

for females.

- Alanine aminotransferase greater than or equal to 2. 5 times the upper limit of

normal.

- Serum creatinine greater than or equal to 1. 5 mg/dL for males and 1. 4 for females, or

calculated creatinine clearance less than or equal to 50 L/min.

- Males intending to impregnate others or donate sperm before, during or within 1 month

after participating in the study.

- A history of cancer other than squamous or basal cell carcinoma of the skin that has

not been in full remission for at least 5 yrs.

- A history of laser treatment for diabetic retinopathy within 6 months of screening.

- Treated for diabetic gastric paresis, gastric banding, or gastric bypass.

- New York Heart Association Class III or IV heart failure.

- History of coronary angioplasty, coronary stent placement, coronary bypass surgery,

myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening.

- Known history of human immunodeficiency virus, hepatitis B or C.

- Alcohol or substance abuse within 2 years prior to screening.

- Is required to take or intends to continue taking any disallowed medication, any

prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

- Any investigational drug within 30 days

- Any investigational diabetic drug within 3 months

- Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like

peptide-1 mimetics classes anytime other than metformin

- Prior treatment with alogliptin.

- Weight-loss drugs

- Investigational antidiabetics

- Oral or systemically injected glucocorticoids

- A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4

drug, metformin or glipizide.

Takeda Study Registration Call Center, Phone: 800-778-2860, Email: medicalinformation@tpna.com

Salzburg, Austria; Not yet recruiting

Vienna, Austria; Not yet recruiting

Haifa, Germany; Not yet recruiting

Kelkheim, Germany; Not yet recruiting

Mainz, Germany; Not yet recruiting

Münster, Germany; Not yet recruiting

Offenbach, Germany; Not yet recruiting

Budapest, Hungary; Recruiting

Gyula, Hungary; Not yet recruiting

Kalocsa, Hungary; Not yet recruiting

Mako, Hungary; Recruiting

Miskolc, Hungary; Not yet recruiting

Nyíregyháza, Hungary; Not yet recruiting

Pécs, Hungary; Not yet recruiting

Szentes, Hungary; Not yet recruiting

Zalaegerszeg, Hungary; Recruiting

Ashkelon, Israel; Not yet recruiting

Beer-Sheva, Israel; Not yet recruiting

Hadera, Israel; Not yet recruiting

Holon, Israel; Not yet recruiting

Jerusalem, Israel; Not yet recruiting

Kfar Saba, Israel; Not yet recruiting

Nahariya, Israel; Not yet recruiting

Petach Tikva, Israel; Not yet recruiting

Tel- Aviv, Israel; Not yet recruiting

Zefat, Israel; Not yet recruiting

Milano, Italy; Not yet recruiting

Perugia, Italy; Not yet recruiting

Pistoia, Italy; Not yet recruiting

Daugavpils, Latvia; Not yet recruiting

Liepaja, Latvia; Not yet recruiting

Limbazi, Latvia; Recruiting

Ogre, Latvia; Recruiting

Riga, Latvia; Not yet recruiting

Talsi, Latvia; Not yet recruiting

Tukums, Latvia; Recruiting

Valmiera, Latvia; Not yet recruiting

Alytus, Lithuania; Not yet recruiting

Kaunas, Lithuania; Not yet recruiting

Kedainiai, Lithuania; Not yet recruiting

Klaipeda, Lithuania; Not yet recruiting

Palanga, Lithuania; Not yet recruiting

Panevezys, Lithuania; Not yet recruiting

Vilnius, Lithuania; Not yet recruiting

Bytom, Poland; Not yet recruiting

Gniewkowo, Poland; Not yet recruiting

Krakow, Poland; Not yet recruiting

Plock, Poland; Not yet recruiting

Radom, Poland; Not yet recruiting

Tychy, Poland; Not yet recruiting

Warszawa, Poland; Not yet recruiting

Bacau, Romania; Not yet recruiting

Bucharest, Romania; Not yet recruiting

Galati, Romania; Not yet recruiting

Oradea, Romania; Not yet recruiting

Rzeszow, Romania; Not yet recruiting

Sibiu, Romania; Not yet recruiting

Tg Mures, Romania; Not yet recruiting

Arkhangelsk, Russian Federation; Not yet recruiting

Irkutsk, Russian Federation; Not yet recruiting

Moscow, Russian Federation; Not yet recruiting

Samara, Russian Federation; Not yet recruiting

Smolensk, Russian Federation; Not yet recruiting

St Petersburg, Russian Federation; Not yet recruiting

Yaroslavl, Russian Federation; Not yet recruiting

Cape Town, South Africa; Not yet recruiting

Durban, South Africa; Not yet recruiting

Johannesburg, South Africa; Not yet recruiting

Port Elizabeth, South Africa; Not yet recruiting

Pretoria, South Africa; Not yet recruiting

Alicante, Spain; Not yet recruiting

Barcelona, Spain; Not yet recruiting

Madrid, Spain; Not yet recruiting

Santiago de Compostela, Spain; Not yet recruiting

Valencia, Spain; Not yet recruiting

Dnepropertovsk, Ukraine; Not yet recruiting

Donetsk, Ukraine; Not yet recruiting

Kharkiv, Ukraine; Not yet recruiting

Kyiv, Ukraine; Not yet recruiting

Lviv, Ukraine; Not yet recruiting

Vinnytsa, Ukraine; Not yet recruiting

Zaporizhye, Ukraine; Not yet recruiting

Bath, United Kingdom; Not yet recruiting

Bournemouth, United Kingdom; Not yet recruiting

Dundee, United Kingdom; Not yet recruiting

Liverpool, United Kingdom; Not yet recruiting

London, United Kingdom; Not yet recruiting

Maidstone, United Kingdom; Not yet recruiting

Penarth, United Kingdom; Not yet recruiting

Stevenage, United Kingdom; Not yet recruiting

Swansea, United Kingdom; Not yet recruiting

Birmingham, Alabama, United States; Withdrawn

Montgomery, Alabama, United States; Recruiting

Muscle Shoals, Alabama, United States; Recruiting

Pell City, Alabama, United States; Recruiting

Hyderabad, Andhra Pradesh, India; Recruiting

Mesa, Arizona, United States; Recruiting

Phoenix, Arizona, United States; Recruiting

Sierra Vista, Arizona, United States; Recruiting

Tempe, Arizona, United States; Recruiting

Tucson, Arizona, United States; Recruiting

Patna, Bihar, India; Recruiting

Artesia, California, United States; Recruiting

Chico, California, United States; Recruiting

Irvine, California, United States; Recruiting

Los Alamitos, California, United States; Recruiting

Mission Viejo, California, United States; Recruiting

National City, California, United States; Recruiting

Northridge, California, United States; Recruiting

Pismo Beach, California, United States; Recruiting

Roseville, California, United States; Recruiting

Sacramento, California, United States; Recruiting

San Diego, California, United States; Recruiting

Santa Monica, California, United States; Recruiting

Tustin, California, United States; Recruiting

Anaheim, California, United States; Recruiting

Arvada, Colorado, United States; Recruiting

Colorado Springs, Colorado, United States; Recruiting

Ridgefield, Connecticut, United States; Recruiting

Waterbury, Connecticut, United States; Recruiting

Brooksville, Florida, United States; Recruiting

New Port Richey, Florida, United States; Recruiting

North Miami Beach, Florida, United States; Recruiting

Opa Locka, Florida, United States; Recruiting

Orlando, Florida, United States; Recruiting

St Petersburg, Florida, United States; Withdrawn

Augusta, Georgia, United States; Recruiting

Savannah, Georgia, United States; Recruiting

Karnal, Haryana, India; Recruiting

Addison, Illinois, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Bloomington, Indiana, United States; Recruiting

Indianapolis, Indiana, United States; Recruiting

Mishawaka, Indiana, United States; Recruiting

Evansville, Indiana, United States; Recruiting

Wichita, Kansas, United States; Withdrawn

Bangalore, Karnataka, India; Recruiting

Belgaum, Karnataka, India; Recruiting

Lexington, Kentucky, United States; Recruiting

Munfordville, Kentucky, United States; Recruiting

Marrero, Louisiana, United States; Recruiting

Mumbai, Maharashtra, India; Recruiting

Bangor, Maine, United States; Recruiting

Elkridge, Maryland, United States; Recruiting

Oxon Hill, Maryland, United States; Recruiting

North Dartmouth, Massachusetts, United States; Recruiting

Ann Arbor, Michigan, United States; Recruiting

Flint, Michigan, United States; Recruiting

Picayune, Mississippi, United States; Recruiting

Springfield, Missouri, United States; Recruiting

St. Louis, Missouri, United States; Recruiting

St Peters, Missouri, United States; Recruiting

Omaha, Nebraska, United States; Recruiting

Las Vegas, Nevada, United States; Recruiting

Albuquerque, New Mexico, United States; Recruiting

New Windsor, New York, United States; Recruiting

New York, New York, United States; Recruiting

Rochester, New York, United States; Recruiting

Fargo, North Dakota, United States; Recruiting

Beachwood, Ohio, United States; Recruiting

Cincinnati, Ohio, United States; Recruiting

Dayton, Ohio, United States; Recruiting

Willoughby Hills, Ohio, United States; Recruiting

Zanesville, Ohio, United States; Recruiting

Norman, Oklahoma, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Medford, Oregon, United States; Recruiting

Havertown, Pennsylvania, United States; Recruiting

Norristown, Pennsylvania, United States; Recruiting

Philadelphia, Pennsylvania, United States; Recruiting

Pittsburgh, Pennsylvania, United States; Recruiting

Tipton, Pennsylvania, United States; Recruiting

Anderson, South Carolina, United States; Recruiting

Charleston, South Carolina, United States; Recruiting

Greer, South Carolina, United States; Recruiting

Rapid City, South Dakota, United States; Recruiting

Trichy, Tamil Nadu, India; Recruiting

New Tazewell, Tennessee, United States; Recruiting

Arlington, Texas, United States; Recruiting

Carrollton, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

Fort Worth, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

Hurst, Texas, United States; Recruiting

Katy, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Spring, Texas, United States; Recruiting

Temple, Texas, United States; Recruiting

Midvale, Utah, United States; Recruiting

Hampton, Virginia, United States; Recruiting

Richmond, Virginia, United States; Recruiting

Lewisburg, West Virginia, United States; Recruiting

Milwaukee, Wisconsin, United States; Recruiting

Starting date: April 2009
Ending date: April 2013
Last updated: September 24, 2009