Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
ENDURE
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
7 other identifiers
interventional
2,639
31 countries
257
Brief Summary
The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Mar 2009
Longer than P75 for phase_3 type-2-diabetes-mellitus
257 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 4, 2009
CompletedFirst Posted
Study publicly available on registry
March 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
December 3, 2013
CompletedDecember 3, 2013
September 1, 2013
3.6 years
March 4, 2009
September 25, 2013
September 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Baseline and Week 52
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104
The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Baseline and Week 104
Secondary Outcomes (5)
Change From Baseline in Glycosylated Hemoglobin at Other Time Points
Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.
Change From Baseline in Fasting Plasma Glucose Over Time
Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%
Weeks 26, 52, 78, and 104.
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%
Weeks 26, 52, 78, and 104.
Change From Baseline in Body Weight Over Time
Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.
Study Arms (3)
Metformin + Alogliptin 12.5 mg
EXPERIMENTALAlogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
Metformin + Alogliptin 25 mg
EXPERIMENTALAlogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
Metformin + Glipizide
ACTIVE COMPARATORGlipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
Interventions
Alogliptin tablets
Metformin tablets
Eligibility Criteria
You may qualify if:
- Has a diagnosis of type 2 diabetes mellitus.
- Must meet one of the following:
- Has been 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.
- Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 - 10%, inclusive) on metformin \<1500 mg without documented maximum tolerated dose.
- No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B).
- Has body mass index within 23 kg/m\^2 and 45 kg/m\^2 unless the patient is Asian or of Asian descent, for whom the allowable body mass index will be ≥ 20 kg/m\^2 and ≤ 35 kg/m\^2, inclusive.
- 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 weeks prior to Screening/Pre-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.
You may not qualify if:
- 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 at Screening Visit.
- Alanine aminotransferase greater than or equal to 2.5 times the upper limit of normal at Screening Visit.
- Serum creatinine greater than or equal to 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance less than 60 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 years.
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (261)
Unknown Facility
Montgomery, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
Unknown Facility
Pell City, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Peoria, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Sierra Vista, Arizona, United States
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Artesia, California, United States
Unknown Facility
Chico, California, United States
Unknown Facility
Los Alamitos, California, United States
Unknown Facility
Mission Viejo, California, United States
Unknown Facility
National City, California, United States
Unknown Facility
Northridge, California, United States
Unknown Facility
Pismo Beach, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
Roseville, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
Arvada, Colorado, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Ridgefield, Connecticut, United States
Unknown Facility
Waterbury, Connecticut, United States
Unknown Facility
Brooksville, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
North Miami Beach, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Opa-locka, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Savannah, Georgia, United States
Unknown Facility
Addison, Illinois, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Bloomington, Indiana, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Mishawaka, Indiana, United States
Unknown Facility
South Bend, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Munfordville, Kentucky, United States
Unknown Facility
Marrero, Louisiana, United States
Unknown Facility
Bangor, Maine, United States
Unknown Facility
Elkridge, Maryland, United States
Unknown Facility
Oxon Hill, Maryland, United States
Unknown Facility
North Dartmouth, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Flint, Michigan, United States
Unknown Facility
Picayune, Mississippi, United States
Unknown Facility
City of Saint Peters, Missouri, United States
Unknown Facility
Springfield, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New Windsor, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Fargo, North Dakota, United States
Unknown Facility
Beachwood, Ohio, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Willoughby Hills, Ohio, United States
Unknown Facility
Zanesville, Ohio, United States
Unknown Facility
Norman, Oklahoma, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Havertown, Pennsylvania, United States
Unknown Facility
Norristown, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Tipton, Pennsylvania, United States
Unknown Facility
Anderson, South Carolina, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Rapid City, South Dakota, United States
Unknown Facility
New Tazewell, Tennessee, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Carrollton, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Hurst, Texas, United States
Unknown Facility
Katy, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Spring, Texas, United States
Unknown Facility
Temple, Texas, United States
Unknown Facility
Midvale, Utah, United States
Unknown Facility
Hampton, Virginia, United States
Unknown Facility
Lewisburg, West Virginia, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Mar del Plata, Argentina
Unknown Facility
Garran, Australian Capital Territory, Australia
Unknown Facility
Wollongong, New South Wales, Australia
Unknown Facility
Herston, Queensland, Australia
Unknown Facility
Nedlands, Western Australia, Australia
Unknown Facility
Graz, Austria
Unknown Facility
Salzburg, Austria
Unknown Facility
Recife, Pernambuco, Brazil
Unknown Facility
Brasília - DF, Planalto Central, Brazil
Unknown Facility
Mogi das Cruzes, São Paulo, Brazil
Unknown Facility
São Paulo, São Paulo, Brazil
Unknown Facility
Fortaleza, Brazil
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Brampton, Ontario, Canada
Unknown Facility
Collingwood, Ontario, Canada
Unknown Facility
Corunna, Ontario, Canada
Unknown Facility
Etobichoke, Ontario, Canada
Unknown Facility
Etobicoke, Ontario, Canada
Unknown Facility
Mississauga, Ontario, Canada
Unknown Facility
Smith Falls, Ontario, Canada
Unknown Facility
Smiths Falls, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Granby, Quebec, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Providencia, Santiago Metropolitan, Chile
Unknown Facility
Santiago, Santiago Metropolitan, Chile
Unknown Facility
Potsdam, Brandenburg, Germany
Unknown Facility
Kelkheim, Hesse, Germany
Unknown Facility
Offenbach, Hesse, Germany
Unknown Facility
Münster, North Rhine-Westphalia, Germany
Unknown Facility
Mainz, Rhineland-Palatinate, Germany
Unknown Facility
Neuwied, Rhineland-Palatinate, Germany
Unknown Facility
Rhaunen, Rhineland-Palatinate, Germany
Unknown Facility
Guatemala City, Departamento de Guatemala, Guatemala
Unknown Facility
Kowloon, Kowloon, Hong Kong
Unknown Facility
Wong Tai Sin, Kowloon, Hong Kong
Unknown Facility
Pok Fu Lam, Southern District, Hong Kong
Unknown Facility
Pécs, Baranya, Hungary
Unknown Facility
Gyula, Bekes County, Hungary
Unknown Facility
Miskolc, Borsod-Abauj Zemplen county, Hungary
Unknown Facility
Budapest, Budapest, Hungary
Unknown Facility
Kalocsa, Bács-Kiskun county, Hungary
Unknown Facility
Makó, Csongrád megye, Hungary
Unknown Facility
Szentes, Csongrád megye, Hungary
Unknown Facility
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Unknown Facility
Zalaegerszeg, Zala County, Hungary
Unknown Facility
Hyderabad, Andhra Pradesh, India
Unknown Facility
Patna, Bihar, India
Unknown Facility
Karnāl, Haryana, India
Unknown Facility
Bangalore, Karnataka, India
Unknown Facility
Belagavi, Karnataka, India
Unknown Facility
Bhopal, Madhya Pradesh, India
Unknown Facility
Mumbai, Maharashtra, India
Unknown Facility
Trichy, Tamil Nadu, India
Unknown Facility
Kfar Saba, Center District, Israel
Unknown Facility
Kfar Saba, Central District, Israel
Unknown Facility
Matan, Central District, Israel
Unknown Facility
Petah Tikva, Central District, Israel
Unknown Facility
Hadera, Haifa District, Israel
Unknown Facility
Haifa, Haifa District, Israel
Unknown Facility
Jerusalem, Jerusalem, Israel
Unknown Facility
Nahariya, Northern District, Israel
Unknown Facility
Safed, Northern District, Israel
Unknown Facility
Ashkelon, Southern District, Israel
Unknown Facility
Beersheba, Southern District, Israel
Unknown Facility
Holon, Tel Aviv, Israel
Unknown Facility
Tel Aviv, Tel Aviv, Israel
Unknown Facility
Safed, Israel
Unknown Facility
Milan, Milan, Italy
Unknown Facility
Perugia, Perugia, Italy
Unknown Facility
Pistoia, Pistoia, Italy
Unknown Facility
Daugavpils, Latvia
Unknown Facility
Liepāja, Latvia
Unknown Facility
Limbaži, Latvia
Unknown Facility
Ogre, Latvia
Unknown Facility
Riga, Latvia
Unknown Facility
Talsi, Latvia
Unknown Facility
Tukums, Latvia
Unknown Facility
Valmiera, Latvia
Unknown Facility
Alytus, Lithuania
Unknown Facility
Kaunas, Lithuania
Unknown Facility
Kėdainiai, Lithuania
Unknown Facility
Klaipėda, Lithuania
Unknown Facility
Palanga, Lithuania
Unknown Facility
Panevezys, Lithuania
Unknown Facility
Vilnius, Lithuania
Unknown Facility
Ipoh, Malaysia
Unknown Facility
Kajang, Malaysia
Unknown Facility
Kota Bharu, Malaysia
Unknown Facility
Kuala Terengganu, Malaysia
Unknown Facility
Kuantan, Malaysia
Unknown Facility
Malacca, Malaysia
Unknown Facility
Taiping, Malaysia
Unknown Facility
Tlalnepantla, Edo de Mexico, Mexico
Unknown Facility
Guadalajara, Jalisco, Mexico
Unknown Facility
Mexico City, Mexico City, Mexico
Unknown Facility
Monterrey, Nuevo León, Mexico
Unknown Facility
Huixquilucan Edo. de Mexico, Mexico
Unknown Facility
Mexico City, Mexico
Unknown Facility
Auckland, New Zealand
Unknown Facility
Christchurch, New Zealand
Unknown Facility
Hamilton, New Zealand
Unknown Facility
Otahuhu, New Zealand
Unknown Facility
Palmerston North, New Zealand
Unknown Facility
Takapuna, New Zealand
Unknown Facility
Tauranga, New Zealand
Unknown Facility
Wellington, New Zealand
Unknown Facility
Chiclayo, Lambayeque, Peru
Unknown Facility
Lima, San Juan de Miraflores, Peru
Unknown Facility
Ica, Peru
Unknown Facility
Manila, Philippines
Unknown Facility
Bytom, Poland
Unknown Facility
Gniewkowo, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Radom, Poland
Unknown Facility
Rzeszów, Poland
Unknown Facility
Tychy, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Ponce, Puerto Rico
Unknown Facility
San Juan, Puerto Rico
Unknown Facility
Bacau, Romania
Unknown Facility
Bucharest, Romania
Unknown Facility
Galati, Romania
Unknown Facility
Oradea, Romania
Unknown Facility
Sibiu, Romania
Unknown Facility
Târgu Mureş, Romania
Unknown Facility
Arkhangelsk, Russia
Unknown Facility
Irkutsk, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Samara, Russia
Unknown Facility
Smolensk, Russia
Unknown Facility
Yaroslavl, Russia
Unknown Facility
Singapore, Singapore
Unknown Facility
Port Elizabeth, Eastern Cape, South Africa
Unknown Facility
Johannesburg, Gauteng, South Africa
Unknown Facility
Pretoria, Gauteng, South Africa
Unknown Facility
Durban, KwaZulu-Natal, South Africa
Unknown Facility
Tongaat, KwaZulu-Natal, South Africa
Unknown Facility
Cape Town, Western Cape, South Africa
Unknown Facility
Gwangju, Honam, South Korea
Unknown Facility
Daejeon, Hoseo, South Korea
Unknown Facility
Daegu, Yeongnam, South Korea
Unknown Facility
Barcelona, Catalonia, Spain
Unknown Facility
Santiago de Compostela, Galicia, Spain
Unknown Facility
Alicante, Spain
Unknown Facility
Amphure Muang, Thailand
Unknown Facility
Bangkok, Thailand
Unknown Facility
Chiang Mai, Thailand
Unknown Facility
Khon Kaen, Thailand
Unknown Facility
Dnepropertovsk, Ukraine
Unknown Facility
Dnipropetrovsk, Ukraine
Unknown Facility
Donetsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Kyiv, Ukraine
Unknown Facility
Lviv, Ukraine
Unknown Facility
Vinnytsa, Ukraine
Unknown Facility
Vinnytsia, Ukraine
Unknown Facility
Zaporizhye, Ukraine
Unknown Facility
Zaporizhzhya, Ukraine
Unknown Facility
Aintree-Liverpool, United Kingdom
Unknown Facility
Bath, United Kingdom
Unknown Facility
Bournemouth, United Kingdom
Unknown Facility
Dundee, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Stevenage, United Kingdom
Unknown Facility
Swansea, United Kingdom
Related Publications (1)
Gordon J, McEwan P, Hurst M, Puelles J. The Cost-Effectiveness of Alogliptin Versus Sulfonylurea as Add-on Therapy to Metformin in Patients with Uncontrolled Type 2 Diabetes Mellitus. Diabetes Ther. 2016 Dec;7(4):825-845. doi: 10.1007/s13300-016-0206-7. Epub 2016 Oct 27.
PMID: 27787778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The Week 52 results summarized in herein differ from the Week 52 results summarized in an interim analysis, because the per protocol set (PPS) defined for the final analysis included fewer subjects than the PPS defined for the interim analysis.
Results Point of Contact
- Title
- Medical Director, Clinical Science
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director, Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2009
First Posted
March 5, 2009
Study Start
March 1, 2009
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
December 3, 2013
Results First Posted
December 3, 2013
Record last verified: 2013-09