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Diabetes Mellitus, Type 2Phase 3NCT01481116

Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes

A Phase 3 study testing TAK-875 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Takeda at 226 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
TAK-875 and Glimepiride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,454 participants
Where
226 sitesin 23 countries
Study dates
Jan 2012to Apr 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  • The participant is male or female and 18 years of age or older with a historical diagnosis of T2DM.
  • The participant meets one of the following criteria:
  • The participant has an HbA1c level ≥7.0 and <10.0%, and has been on a stable daily dose of ≥1500 mg (or documented MTD) of metformin for at least 2 months prior to Screening. This participant will immediately enter the Placebo Run-in Period, or;
  • The participant has an HbA1c level ≥ 7.5 and <10.5%, and has been on a stable daily dose of <1500 mg of metformin without documented MTD for at least 2 months prior to Screening. After completing the Screening Visit, this participant will have their metformin dose immediately increased to ≥1500 mg (or MTD) for an 8-week Titration Period. Following this 8-week period, the participant must qualify for entry into the Placebo Run-in Period by completing the Week -3 procedures and having an HbA1c concentration ≥7.0 and <10.0%.
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  • The participant has had no treatment with antidiabetic agents other than metformin within 2 months prior to Screening (Exception: if a participant has received other antidiabetic therapy for ≤7 days within the 2 months prior to Screening).
  • The participant has a body mass index (BMI) of ≤45 kg/m2 at Screening.
  • Participants regularly using other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
  • The participant is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete participant diaries.
  • Additional Inclusion Criteria Prior to Randomization
  • The participant has an HbA1c concentration ≥7.0% and <10.0%, and a FPG ≤270 mg/dL (15.0 mmol/L) at the Week -1 Visit. (If the subject does not qualify for randomization based on these criteria, the assessment may be repeated weekly, for a maximum of 2 additional weeks).
  • The participant's compliance with the single-blind study medication during the Placebo Run-in Period is at least 75% and does not exceed 125% based on tablet/capsule counts performed by the study staff.
  • A female participant of childbearing potential must have a negative urine hCG pregnancy test at Baseline (Day 1) prior to Randomization and prior to administration of the first dose of double-blind study medication.

Who cannot join

  • The participant has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within the 3 months prior to Screening.
  • The participant has been randomized into a previous TAK-875 study
  • The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
  • The participant donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
  • The participant has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening.
  • The participant has a systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement).
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  • The participant has history of cancer that has been in remission for <5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
  • The participant has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x upper limit of normal (ULN) at Screening.
  • The participant has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome the participant will be allowed with an elevated bilirubin level per the investigator's discretion.
  • The participant has a serum creatinine ≥1.5 mg/dL(males) and ≥1.4 mg/dL(females) and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at Screening.
  • The participant has uncontrolled thyroid disease.
  • The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
  • The participant has had gastric banding, or gastric bypass surgery within one year prior to Screening.
  • The participant has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
  • The participant had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram (ECG), cerebrovascular accident or transient ischemic attack within 3 months prior to or at Screening.
  • The participant has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875, metformin, or glimepiride.
  • The participant has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
  • The participant received excluded medications prior to Screening or is expected to receive excluded medication.
  • If female, the participant is pregnant (confirmed by laboratory testing, i.e., serum/urine human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
  • The participant is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
  • The participant has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the participant according to the protocol.
  • Additional Exclusion Criteria Prior to Randomization
  • The participant has received excluded medications listed in the protocol during the Placebo Run-in Period (topical and inhaled corticosteroids are allowed).
  • The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Baseline (Day 1) (If the subject meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).
  • The participant has a serum creatinine ≥1.5 mg/dL(≥133µmol/L) [males] and ≥1.4 mg/dL (≥124 µmol/L) [females] and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at Visit 3 (Schedule B subjects only).

Trial locations and contacts

226 sites in 23 countries.

226 sites in 23 countries

United States46 sites

  • Study site

    Avon, Indiana

  • Study site

    Bradenton, Florida

  • Study site

    Burke, Virginia

  • Study site

    Calabash, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Clearwater, Florida

  • Study site

    Coral Gables, Florida

  • Study site

    Dallas, Texas

  • Study site

    Decatur, Georgia

  • Study site

    Dothan, Alabama

  • Study site

    El Paso, Texas

  • Study site

    Elizabeth, New Jersey

  • Study site

    Flint, Michigan

  • Study site

    Fort Worth, Texas

  • Study site

    Goodyear, Arizona

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Hampton, Virginia

  • Study site

    Hialeah, Florida

  • Study site

    Houston, Texas

  • Study site

    Jackson, Mississippi

  • Study site

    Long Beach, California

  • Study site

    Manassas, Virginia

  • Study site

    Maumee, Ohio

  • Study site

    Mission Hills, California

  • Study site

    Mooresville, North Carolina

  • Study site

    Morganton, North Carolina

  • Study site

    Muscle Shoals, Alabama

  • Study site

    New Braunfels, Texas

  • Study site

    North Hollywood, California

  • Study site

    Norwalk, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Oxon Hill, Maryland

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Pismo Beach, California

  • Study site

    Raleigh, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Spartanburg, South Carolina

  • Study site

    Spring, Texas

  • Study site

    Tempe, Arizona

  • Study site

    Tomball, Texas

  • Study site

    Topeka, Kansas

Other trials in United States

Poland20 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Gdansk

  • Study site

    Grodzisk Mazowiecki

  • Study site

    Kamieniec Ząbkowicki

  • Study site

    Katowice

  • Study site

    Łęczyca

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Oświęcim

  • Study site

    Parczew

  • Study site

    Płock

  • Study site

    Poznan

  • Study site

    Puławy

  • Study site

    Ruda Śląska

  • Study site

    Rzeszów

  • Study site

    Sopot

  • Study site

    Torun

  • Study site

    Wroclaw

  • Study site

    Zgierz

Other trials in Poland

Israel17 sites

  • Study site

    Ashkelon

  • Study site

    Beer Yaakov

  • Study site

    Beersheba

  • Study site

    Giv‘atayim

  • Study site

    Hadera

  • Study site

    Haifa

  • Study site

    Holon

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Nahariya

  • Study site

    Petah Tikva

  • Study site

    Raanana

  • Study site

    Ramat Gan

  • Study site

    Rehovot

  • Study site

    Rishon LeZiyyon

  • Study site

    Safed

  • Study site

    Tel Aviv

Other trials in Israel

Czechia13 sites

  • Study site

    Benátky nad Jizerou

  • Study site

    Brno

  • Study site

    České Budějovice

  • Study site

    Choceň

  • Study site

    Jindřichův Hradec

  • Study site

    Mariánské Lázně

  • Study site

    Olomouc

  • Study site

    Ostrava

  • Study site

    Ostrava - Moravska Ostrava

  • Study site

    Ostrava - Vitkovice

  • Study site

    Prague

  • Study site

    Praha 4 - Krc

  • Study site

    Znojmo

Other trials in Czechia

South Africa12 sites

  • Study site

    Bloemfontein, Free State

  • Study site

    Cape Town, Western Cape

  • Study site

    Durban, KwaZulu-Natal

  • Study site

    Johannesburg, Gauteng

  • Study site

    Kempton Park, Gauteng

  • Study site

    Krugersdorp, Gauteng

  • Study site

    Middelburg, Mpumalanga

  • Study site

    Port Elizabeth, Eastern Cape

  • Study site

    Pretoria, Gauteng

  • Study site

    Somerset West, Western Cape

  • Study site

    Stellenbosch, Western Cape

  • Study site

    Worcester, Western Cape

Other trials in South Africa

Ukraine12 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Luhansk

  • Study site

    Lviv

  • Study site

    Mykolayiv

  • Study site

    Poltava

  • Study site

    Ternopil

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

Other trials in Ukraine

United Kingdom11 sites

  • Study site

    Bath, Somerset

  • Study site

    Bexhill-on-Sea, East Sussex

  • Study site

    Cardiff, Cardiff

  • Study site

    Cheadle, Cheshire

  • Study site

    Hull, East Riding of Yorkshire

  • Study site

    Liverpool, Merseyside

  • Study site

    Northwood, Middlesex

  • Study site

    Plymouth, Devon

  • Study site

    Swansea, South Glamorgan

  • Study site

    Thornton-Cleveleys, Lancashire

  • Study site

    Watford, Hertfordshire

Other trials in United Kingdom

Canada10 sites

  • Study site

    Laval, Quebec

  • Study site

    Longueuil, Quebec

  • Study site

    Mirabel, Quebec

  • Study site

    Oakville, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Saint-Laurent, Quebec

  • Study site

    Thornhill, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Victoria, British Columbia

Other trials in Canada

Malaysia9 sites

  • Study site

    Ipoh, Perak

  • Study site

    Kuala Lumpur, Kuala Lumpur

  • Study site

    Malacca, Melaka

  • Study site

    Petaling Jaya, Selangor

  • Study site

    Putrajaya, Putrajaya

  • Study site

    Taiping, Perak

  • Study site

    Taiping, Perak, Perak

  • Study site

    Terengganu, Terengganu

  • Study site

    Terengganu

Other trials in Malaysia

Romania9 sites

  • Study site

    Bacau

  • Study site

    Baia Mare

  • Study site

    Bucharest

  • Study site

    Constanța

  • Study site

    Iași

  • Study site

    Oradea

  • Study site

    Ploieşti

  • Study site

    Târgu Mureş

  • Study site

    Timișoara

Other trials in Romania

Bulgaria8 sites

  • Study site

    Blagoevgrad

  • Study site

    Gabrovo

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Sevlievo

  • Study site

    Sofia

  • Study site

    Stara Zagora

  • Study site

    Varna

Other trials in Bulgaria

New Zealand7 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Hamilton

  • Study site

    Palmerston North

  • Study site

    Rotorua

  • Study site

    Tauranga

  • Study site

    Wellington

Other trials in New Zealand

Philippines7 sites

  • Study site

    Cebu City

  • Study site

    Davao City

  • Study site

    Iloilo City

  • Study site

    Lipa City

  • Study site

    Quezon City

  • Study site

    Tarlac City

  • Study site

    Taytay

Other trials in Philippines

Russia7 sites

  • Study site

    Kazan'

  • Study site

    Kemerovo

  • Study site

    Krasnoyarsk

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Saint Petersburg

  • Study site

    Yaroslavl

Other trials in Russia

Argentina6 sites

  • Study site

    Buenos Aires, Ciudad Autonoma Buenos Aires

  • Study site

    Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires

  • Study site

    Córdoba, Córdoba Province

  • Study site

    Córdoba

  • Study site

    Corrientes, Corrientes Province

  • Study site

    Rosario, Santa Fe Province

Other trials in Argentina

Estonia6 sites

  • Study site

    Paide

  • Study site

    Rakvere

  • Study site

    Saku

  • Study site

    Tallinn

  • Study site

    Tartu

  • Study site

    Võru

Other trials in Estonia

Latvia6 sites

  • Study site

    Jelgava

  • Study site

    Limbaži

  • Study site

    Ogre

  • Study site

    Riga

  • Study site

    Talsi

  • Study site

    Valmiera

Other trials in Latvia

Australia5 sites

  • Study site

    Brookvale, New South Wales

  • Study site

    Canberra, Australian Capital Territory

  • Study site

    Canberra

  • Study site

    Mosman, New South Wales

  • Study site

    Woy Woy, New South Wales

Other trials in Australia

Taiwan5 sites

  • Study site

    Chia-Yi City

  • Study site

    New Taipei City

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

Other trials in Taiwan

Lithuania4 sites

  • Study site

    Alytus

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Vilnius

Other trials in Lithuania

Colombia2 sites

  • Study site

    Bogotá

  • Study site

    Medellín

Other trials in Colombia

Hong Kong2 sites

  • Study site

    Hong Kong

  • Study site

    New Territories

Other trials in Hong Kong

Mexico2 sites

  • Study site

    Cuernavaca, Morelos

  • Study site

    Mexico City, Mexico City

Other trials in Mexico

About this study

Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Glimepiride When Used in Combination With Metformin in Subjects With Type 2 Diabetes

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).

Read the detailed description

Type 2 diabetes mellitus (T2DM) has increased dramatically throughout the world over the past decades despite the availability of several different treatment options. Current pharmacologic treatments include insulin, thiazolidinediones, sulfonylureas, metformin, dipeptidyl-peptidase-4 (DPP-4) inhibitors, and glucagon-like peptide-1 (GLP-1) mimetics. A number of these treatments are associated with clinically important side effects such as low blood sugar (hypoglycemia), weight gainflud retention, exaggeration of pre-existent heart failure, and gastrointestinal side effects. These side effects and the disadvantages associated with many of the currently available antidiabetic agents can reduce compliance and limit their long-term use.

Insulin is a hormone that is produced by the body to regulate blood sugar (glucose). In individuals with T2DM, the insulin produced by the body does not effectively control the amount of sugar in the bloodstream. If not properly managed, T2DM may cause elevated blood sugar levels (hyperglycemia) and ultimately result in serious health problems.

In response to this problem, Takeda is developing TAK-875 (an investigational drug) as an addition to diet and exercise to improve blood sugar control in patients with T2DM. TAK-875 may affect the production of insulin and may improve how the body uses the sugar in the blood.

The aim of this study is to find out if TAK-875, when taken for approximately 2 years in combination with current diabetes medicine (called metformin), is safe and effective at helping people with T2DM control their high blood sugar when compared to glimepiride (a type of medication called a sulfonylurea). The study is being done to find out if the combination of TAK-875 plus metformin works as well as the combination of glimepiride plus metformin.

Approximately 2430 patients worldwide aged 18 or over with T2DM, will take part in this study and will be involved in the study for up to 110 or 120 weeks.

TAK-875 is being developed at Takeda Global Research and Development, Inc. as an adjunct to diet and exercise to improve glycemic control in participants with T2DM.

This study will investigate TAK-875 in participants with type 2 diabetes mellitus whose blood sugar level is inadequately controlled with metformin monotherapy.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Being tested
TAK-875, Glimepiride
Keywords
Drug Therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • TAK-875Drug

    TAK-875 25 mg, tablets, orally, once daily and metformin ≥1500 mg or Maximum Tolerated Dose (MTD) for up to 104 weeks.

  • TAK-875Drug

    TAK-875 50 mg, tablets, orally, once daily and metformin ≥1500 mg or MTD for up to 104 weeks.

  • GlimepirideDrug

    Glimepiride 1 mg, tablets, orally, once daily (up-titrated to 2 mg after 1 week of treatment. Up-titrated to a maximum of 6 mg in 2 mg increments/down titrated if recurrent (or severe) hypoglycemia occurs) and metformin ≥1500 mg or MTD for up to 104 weeks.

Study groups in NCT01481116
Study groupRoleWhat they receive
TAK-875 25 mg QDExperimentalNot described
Receives: Drug: TAK-875
TAK-875 50 mg QDExperimentalNot described
Receives: Drug: TAK-875
Glimepiride 1-2 mg QDActive comparatorNot described
Receives: Drug: Glimepiride

What is being measured

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

  1. Change From Baseline in HbA1c at Weeks 78 and 104

    The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline.

    Measured: Baseline and Weeks 78 and 104

Secondary outcomes (6)

  1. Percentage of Participants With Hypoglycemia

    Participants were provided diaries to document any hypoglycemic events that occurred between study visits. Any experience of hypoglycemic signs and symptoms (regardless of the blood glucose value by glucometer) or had a blood glucose value less than or equal to (<=) 70 milligram per deciliter (mg/dL) (3.9 millimole per liter (mmol/L) by glucometer (regardless of symptoms) were to be recorded.

    Measured: Day 1 up to Weeks 78 and 104

  2. Change From Baseline in Body Weight at Weeks 78 and 104

    The change between the body weight to be collected at Weeks 78 and 104 relative to baseline.

    Measured: Baseline and Weeks 78 and 104

  3. Change From Baseline in HbA1c at Weeks 26 and 52

    The change in the value of HbA1c collected at Weeks 26 and 52 relative to baseline.

    Measured: Baseline and Weeks 26 and 52

  4. Percentage of Participants With HbA1c <7%

    Measured: Weeks 26, 52, 78 and 104

  5. Percentage of Participants With HbA1c <7% for Participants Who Did Not Report Hypoglycemia

    Measured: Weeks 26, 52, 78 and 104

  6. Change From Baseline in Fasting Plasma Glucose at Weeks 26, 52, 78 and 104

    The change between the fasting plasma glucose value to be collected at Weeks 26, 52, 78 and 104 relative to baseline.

    Measured: Baseline and Weeks 26, 52, 78 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 posted29 Nov 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionMar 2014
  4. Study completionApr 2014

Why it stopped: Due to potential concerns about liver safety (See Detailed Description)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,454 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01481116
Sponsor's protocol ID
TAK-875_304
Other IDs
2011-001731-24, U1111-1124-2296, TAK-875_304CTIL, DOH-27-0512-3913, 11-057, NMRR-11-882-10318, HKCTR-1616, 262
Status last verified
Apr 2016
First submitted
25 Nov 2011
Last updated
1 Jun 2016
Data monitoring committee
Yes

Publications

  • Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.

    PubMed 30880443

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-875 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Takeda at 226 sites in 23 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 14 inclusion and 25 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: stopped early, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Poland, Israel, Czechia, South Africa and 18 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 1 Jun 2016). 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 HbA1c at Weeks 78 and 104 (time frame: Baseline and Weeks 78 and 104). 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 NCT01481116, 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 1 Jun 2016.

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