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AzTrials

Type 2 Diabetes MellitusPhase 3ENDURENCT00856284

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

A Phase 3 study testing Alogliptin, Metformin and Glipizide in people with Type 2 Diabetes Mellitus, run by Takeda at 261 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Alogliptin, Metformin and Glipizide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,639 participants
Where
261 sitesin 32 countries
Study dates
Mar 2009to Oct 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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 within 90 days prior to Screening other than metformin
  • Prior treatment with alogliptin.
  • Weight-loss drugs
  • Oral or systemically injected glucocorticoids
  • A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide.
  • Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).

Trial locations and contacts

261 sites in 32 countries.

261 sites in 32 countries

United States94 sites

  • Study site

    Addison, Illinois

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Ann Arbor, Michigan

  • Study site

    Arlington, Texas

  • Study site

    Artesia, California

  • Study site

    Arvada, Colorado

  • Study site

    Augusta, Georgia

  • Study site

    Bangor, Maine

  • Study site

    Beachwood, Ohio

  • Study site

    Bloomington, Indiana

  • Study site

    Brooksville, Florida

  • Study site

    Carrollton, Texas

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Chico, California

  • Study site

    Cincinnati, Ohio

  • Study site

    City of Saint Peters, Missouri

  • Study site

    Colorado Springs, Colorado

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Elkridge, Maryland

  • Study site

    Evansville, Indiana

  • Study site

    Fargo, North Dakota

  • Study site

    Flint, Michigan

  • Study site

    Fort Worth, Texas

  • Study site

    Greer, South Carolina

  • Study site

    Hampton, Virginia

  • Study site

    Havertown, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Hurst, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Katy, Texas

  • Study site

    Las Vegas, Nevada

  • Study site

    Lewisburg, West Virginia

  • Study site

    Lexington, Kentucky

  • Study site

    Los Alamitos, California

  • Study site

    Marrero, Louisiana

  • Study site

    Medford, Oregon

  • Study site

    Mesa, Arizona

  • Study site

    Midvale, Utah

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mishawaka, Indiana

  • Study site

    Mission Viejo, California

  • Study site

    Montgomery, Alabama

  • Study site

    Munfordville, Kentucky

  • Study site

    Muscle Shoals, Alabama

  • Study site

    National City, California

  • Study site

    New Port Richey, Florida

  • Study site

    New Tazewell, Tennessee

  • Study site

    New Windsor, New York

  • Study site

    New York, New York

  • Study site

    Norman, Oklahoma

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Dartmouth, Massachusetts

  • Study site

    North Miami Beach, Florida

  • Study site

    Northridge, California

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Opa-locka, Florida

  • Study site

    Orlando, Florida

  • Study site

    Oxon Hill, Maryland

  • Study site

    Pell City, Alabama

  • Study site

    Peoria, Arizona

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Picayune, Mississippi

  • Study site

    Pismo Beach, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Rapid City, South Dakota

  • Study site

    Ridgefield, Connecticut

  • Study site

    Riverside, California

  • Study site

    Rochester, New York

  • Study site

    Roseville, California

  • Study site

    Sacramento, California

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Monica, California

  • Study site

    Savannah, Georgia

  • Study site

    Sierra Vista, Arizona

  • Study site

    South Bend, Indiana

  • Study site

    Spring, Texas

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    Tempe, Arizona

  • Study site

    Temple, Texas

  • Study site

    Tipton, Pennsylvania

  • Study site

    Tucson, Arizona

  • Study site

    Tustin, California

  • Study site

    Waterbury, Connecticut

  • Study site

    Willoughby Hills, Ohio

  • Study site

    Zanesville, Ohio

Other trials in United States

Israel14 sites

  • Study site

    Ashkelon, Southern District

  • Study site

    Beersheba, Southern District

  • Study site

    Hadera, Haifa District

  • Study site

    Haifa, Haifa District

  • Study site

    Holon, Tel Aviv

  • Study site

    Jerusalem, Jerusalem

  • Study site

    Kfar Saba, Center District

  • Study site

    Kfar Saba, Central District

  • Study site

    Matan, Central District

  • Study site

    Nahariya, Northern District

  • Study site

    Petah Tikva, Central District

  • Study site

    Safed, Northern District

  • Study site

    Safed

  • Study site

    Tel Aviv, Tel Aviv

Other trials in Israel

Canada12 sites

  • Study site

    Brampton, Ontario

  • Study site

    Collingwood, Ontario

  • Study site

    Corunna, Ontario

  • Study site

    Etobichoke, Ontario

  • Study site

    Etobicoke, Ontario

  • Study site

    Granby, Quebec

  • Study site

    Mississauga, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Smith Falls, Ontario

  • Study site

    Smiths Falls, Ontario

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

Other trials in Canada

Ukraine10 sites

  • Study site

    Dnepropertovsk

  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Vinnytsa

  • Study site

    Vinnytsia

  • Study site

    Zaporizhye

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Hungary9 sites

  • Study site

    Budapest, Budapest

  • Study site

    Gyula, Bekes County

  • Study site

    Kalocsa, Bács-Kiskun county

  • Study site

    Makó, Csongrád megye

  • Study site

    Miskolc, Borsod-Abauj Zemplen county

  • Study site

    Nyíregyháza, Szabolcs-Szatmár-Bereg

  • Study site

    Pécs, Baranya

  • Study site

    Szentes, Csongrád megye

  • Study site

    Zalaegerszeg, Zala County

Other trials in Hungary

India8 sites

  • Study site

    Bangalore, Karnataka

  • Study site

    Belagavi, Karnataka

  • Study site

    Bhopal, Madhya Pradesh

  • Study site

    Hyderabad, Andhra Pradesh

  • Study site

    Karnāl, Haryana

  • Study site

    Mumbai, Maharashtra

  • Study site

    Patna, Bihar

  • Study site

    Trichy, Tamil Nadu

Other trials in India

Latvia8 sites

  • Study site

    Daugavpils

  • Study site

    Liepāja

  • Study site

    Limbaži

  • Study site

    Ogre

  • Study site

    Riga

  • Study site

    Talsi

  • Study site

    Tukums

  • Study site

    Valmiera

Other trials in Latvia

New Zealand8 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Hamilton

  • Study site

    Otahuhu

  • Study site

    Palmerston North

  • Study site

    Takapuna

  • Study site

    Tauranga

  • Study site

    Wellington

Other trials in New Zealand

Germany7 sites

  • Study site

    Kelkheim, Hesse

  • Study site

    Mainz, Rhineland-Palatinate

  • Study site

    Münster, North Rhine-Westphalia

  • Study site

    Neuwied, Rhineland-Palatinate

  • Study site

    Offenbach, Hesse

  • Study site

    Potsdam, Brandenburg

  • Study site

    Rhaunen, Rhineland-Palatinate

Other trials in Germany

Lithuania7 sites

  • Study site

    Alytus

  • Study site

    Kaunas

  • Study site

    Kėdainiai

  • Study site

    Klaipėda

  • Study site

    Palanga

  • Study site

    Panevezys

  • Study site

    Vilnius

Other trials in Lithuania

Malaysia7 sites

  • Study site

    Ipoh

  • Study site

    Kajang

  • Study site

    Kota Bharu

  • Study site

    Kuala Terengganu

  • Study site

    Kuantan

  • Study site

    Malacca

  • Study site

    Taiping

Other trials in Malaysia

Poland7 sites

  • Study site

    Bytom

  • Study site

    Gniewkowo

  • Study site

    Krakow

  • Study site

    Radom

  • Study site

    Rzeszów

  • Study site

    Tychy

  • Study site

    Warsaw

Other trials in Poland

Russia7 sites

  • Study site

    Arkhangelsk

  • Study site

    Irkutsk

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Smolensk

  • Study site

    Yaroslavl

Other trials in Russia

United Kingdom7 sites

  • Study site

    Aintree-Liverpool

  • Study site

    Bath

  • Study site

    Bournemouth

  • Study site

    Dundee

  • Study site

    London

  • Study site

    Stevenage

  • Study site

    Swansea

Other trials in United Kingdom

Mexico6 sites

  • Study site

    Guadalajara, Jalisco

  • Study site

    Huixquilucan Edo. de Mexico

  • Study site

    Mexico City, Mexico City

  • Study site

    Mexico City

  • Study site

    Monterrey, Nuevo León

  • Study site

    Tlalnepantla, Edo de Mexico

Other trials in Mexico

Romania6 sites

  • Study site

    Bacau

  • Study site

    Bucharest

  • Study site

    Galati

  • Study site

    Oradea

  • Study site

    Sibiu

  • Study site

    Târgu Mureş

Other trials in Romania

South Africa6 sites

  • Study site

    Cape Town, Western Cape

  • Study site

    Durban, KwaZulu-Natal

  • Study site

    Johannesburg, Gauteng

  • Study site

    Port Elizabeth, Eastern Cape

  • Study site

    Pretoria, Gauteng

  • Study site

    Tongaat, KwaZulu-Natal

Other trials in South Africa

Brazil5 sites

  • Study site

    Brasília - DF, Planalto Central

  • Study site

    Fortaleza

  • Study site

    Mogi das Cruzes, São Paulo

  • Study site

    Recife, Pernambuco

  • Study site

    São Paulo, São Paulo

Other trials in Brazil

Australia4 sites

  • Study site

    Garran, Australian Capital Territory

  • Study site

    Herston, Queensland

  • Study site

    Nedlands, Western Australia

  • Study site

    Wollongong, New South Wales

Other trials in Australia

Thailand4 sites

  • Study site

    Amphure Muang

  • Study site

    Bangkok

  • Study site

    Chiang Mai

  • Study site

    Khon Kaen

Other trials in Thailand

Hong Kong3 sites

  • Study site

    Kowloon, Kowloon

  • Study site

    Pok Fu Lam, Southern District

  • Study site

    Wong Tai Sin, Kowloon

Other trials in Hong Kong

Italy3 sites

  • Study site

    Milan, Milan

  • Study site

    Perugia, Perugia

  • Study site

    Pistoia, Pistoia

Other trials in Italy

Peru3 sites

  • Study site

    Chiclayo, Lambayeque

  • Study site

    Ica

  • Study site

    Lima, San Juan de Miraflores

Other trials in Peru

South Korea3 sites

  • Study site

    Daegu, Yeongnam

  • Study site

    Daejeon, Hoseo

  • Study site

    Gwangju, Honam

Other trials in South Korea

Spain3 sites

  • Study site

    Alicante

  • Study site

    Barcelona, Catalonia

  • Study site

    Santiago de Compostela, Galicia

Other trials in Spain

Austria2 sites

  • Study site

    Graz

  • Study site

    Salzburg

Other trials in Austria

Chile2 sites

  • Study site

    Providencia, Santiago Metropolitan

  • Study site

    Santiago, Santiago Metropolitan

Other trials in Chile

Puerto Rico2 sites

  • Study site

    Ponce

  • Study site

    San Juan

Other trials in Puerto Rico

Argentina1 site

  • Study site

    Mar del Plata

Other trials in Argentina

Guatemala1 site

  • Study site

    Guatemala City, Departamento de Guatemala

Other trials in Guatemala

Philippines1 site

  • Study site

    Manila

Other trials in Philippines

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

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

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.

Read the 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 patients whose blood sugar level is inadequately controlled with metformin therapy.

The duration of this study will be approximately 2 years.

Being tested
Alogliptin, Metformin, Glipizide
Keywords
Diabetes Mellitus, Drug Therapy, Hyperinsulinism, Hyperglycemia, Glucose Intolerance
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Hyperinsulinism, Hyperglycemia, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlogliptinDrug

    Also called SYR-322, Nesina

    Alogliptin tablets

  • MetforminDrug

    Also called Glucophage

    Metformin tablets

  • GlipizideDrug

    Also called Glucotrol

    Glipizide tablets

Study groups in NCT00856284
Study groupRoleWhat they receive
Metformin + Alogliptin 12.5 mgExperimentalAlogliptin 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.
Receives: Drug: Alogliptin; Drug: Metformin
Metformin + Alogliptin 25 mgExperimentalAlogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
Receives: Drug: Alogliptin; Drug: Metformin
Metformin + GlipizideActive 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.
Receives: Drug: Metformin; Drug: Glipizide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 52

  2. 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.

    Measured: Baseline and Week 104

Secondary outcomes (5)

  1. Change From Baseline in Glycosylated Hemoglobin at Other Time Points

    The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.

  2. Change From Baseline in Fasting Plasma Glucose Over Time

    The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates.

    Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.

  3. Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%

    The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.

    Measured: Weeks 26, 52, 78, and 104.

  4. Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%

    Percentage of participants with HbA1c ≤ 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.

    Measured: Weeks 26, 52, 78, and 104.

  5. Change From Baseline in Body Weight Over Time

    LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates.

    Measured: Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,639 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00856284
Sponsor's protocol ID
SYR-322_305
Other IDs
2008-007444-34, U1111-1111-7397, HKCTR-862, DOH-27-0709-2825, 09/H0703/66, NMRR-09-203-3590, 2008
Acronym
ENDURE
Status last verified
Sep 2013
First submitted
4 Mar 2009
Last updated
3 Dec 2013
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27787778

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alogliptin, Metformin and Glipizide in people with Type 2 Diabetes Mellitus, run by Takeda at 261 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 261 sites in United States, Israel, Canada, Ukraine, Hungary and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 (time frame: Baseline and Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00856284, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2013.

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