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Diabetes Type 2Phase 3NCT00309244

Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

A Phase 3 study testing Technosphere® Insulin Inhalation Powder and 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin) in people with Diabetes Type 2, run by Mannkind Corporation at 151 sites in 10 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 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Type 2
What is being tested?
Technosphere® Insulin Inhalation Powder and 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
677 participants
Where
151 sitesin 10 countries
Study dates
Feb 2006to Sep 2008
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

  • Men or women ≥ 18 and ≤ 80 years old
  • Clinical diagnosis of type 2 diabetes mellitus
  • HbA1c > 7.0% and ≤ 11.0%
  • BMI ≤ 40 kg/m2
  • Negative smoking status and urine cotinine test
  • Written informed consent
Show all 9Show fewer
  • Receiving sc insulin 2-3 times daily administered as any of the following 3 regimens: self-mix regimen, pre-mix regimen, or long-acting analogue and regular or rapid-acting insulin analogue not to exceed 3 daily injections. Subjects may also have received oral antidiabetic agents including metformin or thiazolidinediones.
  • No dose adjustments for insulin and oral antidiabetic agents within the preceding 6 weeks.
  • FEV1 ≥ 70% of NHANES III predicted; TLC) ≥ 80% of predicted (Intermountain Thoracic Society); DLCO uncorrected ≥ 70% of predicted

Who cannot join

  • Total daily dose of insulin ≥1.4 IU/kg body weight
  • Treatment with any sulfonylureas and/or meglitinides and/or alpha-glucosidase inhibitors within the preceding 8 weeks
  • Treatment with pramlintide acetate (Symlin®), and/or any incretins (e.g., exenatide [Byetta®]) within the preceding 8 weeks
  • Unstable diabetes mellitus control, defined as 2 or more episodes of severe hypoglycemia (requiring third party intervention) and/or any hospitalization or emergency room visit due to poor diabetic control or hyperglycemia requiring hospitalization within the preceding 6 months
  • Exposure to an inhaled insulin at any time, treatment with an investigational drug within the preceding 3 months, and/or current participation in another clinical trial
  • Allergy to insulin or to any drugs to be used as part of the clinical trial, or history of hypersensitivity to the investigational drug or to drugs of similar chemical structures
Show all 23Show fewer
  • History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes as evidenced by serum aspartate aminotransferase (AST)and/or alanine aminotransferase (ALT) ≥ 3 x Upper Limit of Normal (ULN)(Includes active hepatitis A, positive hepatitis B and/or hepatitis C serology)
  • Serum creatinine > 1.8 mg/dL in women and > 2.0 mg/dL in men History of chronic obstructive pulmonary disease (COPD), asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease confirmed by documented history, pulmonary function testing, or radiologic findings
  • Congestive heart disease graded as class III or class IV according to New York Heart Association criteria and subjects currently being treated pharmacologically for ventricular dysrhythmias using amiodarone
  • History of myocardial infarction, cardiac surgery, coronary angioplasty, and/or stroke within the preceding 3 months
  • Symptomatic coronary artery disease, including crescendo angina, unstable angina, and/or unstable or symptomatic cardiac arrhythmias
  • Poorly controlled arterial hypertension despite pharmacologic treatment, defined as systolic blood pressure (BP) > 180 mm Hg and/or diastolic BP > 110 mm Hg at screening
  • History of malignancy within the preceding 5 years (other than excised basal cell carcinoma of the skin), any history of lung neoplasm, and/or subjects with current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity
  • History of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), or positive human immunodeficiency virus (HIV) serology
  • Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
  • Visit 1/Screening (Week -3), but prior to Visit 1 PFTs and before Visit 3/Baseline (Week 0), subject will be scheduled for PFTs after 30 days from resolution of respiratory infection. An additional hemoglobin and urine β-HCG (for women of childbearing potential age only) will be required
  • Women who are pregnant, lactating or planning to become pregnant
  • Women of childbearing potential (defined as pre-menopausal and not surgically sterilized or postmenopausal for less than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous and/or transdermal contraceptives; condoms and diaphragms with a spermicide, or intrauterine devices
  • Current drug and/or alcohol abuse
  • Subjects who in the opinion of the Investigator will be unable to comply with the requirements of the protocol
  • Severe complications of diabetes mellitus, in the opinion of the Investigator, including: symptomatic autonomic neuropathy, disabling peripheral neuropathy, active proliferative retinopathy; nephropathy with renal failure, renal transplant and/or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene;and/or vascular claudication
  • Any other concurrent medical or major psychiatric condition which, in the opinion of the Investigator, makes the subject unsuitable for the clinical trial, or could limit the validity of the ICF and/or impair the subject's ability to participate in the trial
  • Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) acceptability and repeatability criteria.

Trial locations and contacts

151 sites in 10 countries.

151 sites in 10 countries

United States80 sites

  • New Mexico Clinical Research & Osteoporosis Center

    Albuquerque, New Mexico, 87106

  • University of New Mexico HCS

    Albuquerque, New Mexico, 87131

  • Israel Hartman MD

    Arlington, Texas, 76014

  • South Arlington Primary Care Assoc PA

    Arlington, Texas, 76017

  • Laureate Clinical Research Group

    Atlanta, Georgia, 30308

  • Joslin Diabetes Center University of Maryland Medicine

    Baltimore, Maryland, 21201

  • AM Diabetes and Endocrinology Center

    Bartlett, Tennessee, 38133

  • Pennsylvania Research Institute

    Bensalem, Pennsylvania, 19020

  • Billings Clinic Research Division

    Billings, Montana, 59101

  • Montana Health Research Institute

    Billings, Montana, 59102

  • Valley Medical Primary Care

    Centerville, Ohio, 45459

  • Sensenbrenner Primary Care

    Charlotte, North Carolina, 28277

  • John H Stoger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • International Clinical Research Network

    Chula Vista, California, 91911

  • Amin Radparvar's Private Practice

    City of Saint Peters, Missouri, 63376

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Radiant Research Dallas-North

    Dallas, Texas, 75231

  • Baylor Endocrine Center

    Dallas, Texas, 75246

  • Galenos Research

    Dallas, Texas, 75251

  • Providence Health Partners - Center of Clinical Research

    Dayton, Ohio, 45439

  • Wayne State University

    Detroit, Michigan, 48201

  • Atlanta Pharmaceutical Research Center

    Dunwoody, Georgia, 30338

  • Cleveland Clinic Health System

    East Cleveland, Ohio, 44112

  • Radiant Research Inc (Minneapolis)

    Edina, Minnesota, 55435

  • Oregon Medical Group Clinical Resesarch

    Eugene, Oregon, 97401

  • Lane Medical Research Group

    Eugene, Oregon, 97404

  • Larry D Stonesifer MD Inc PS

    Federal Way, Washington, 98003

  • Saad Hijazi MD Inc

    Fresno, California, 93710

  • Valley Research

    Fresno, California, 93720

  • Spuhler Medical Associates

    Friendswood, Texas, 77546

  • East Carolina University (Tanenberg)

    Greenville, North Carolina, 27834

  • Physician's East PA

    Greenville, North Carolina, 27834

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • Clinical Trial Network

    Houston, Texas, 77074

  • Diabetes/Lipid Management and Research Center

    Huntington Beach, California, 92648

  • South Bay Clinical Research

    Inglewood, California, 90301

  • Wells Institute for Health Awareness

    Kettering, Ohio, 45429

  • North Atlanta Endocrinology & Diabetes PC

    Lawrenceville, Georgia, 30045

  • Michigan Institute of Medicine

    Livonia, Michigan, 48152

  • Memphis Internal Medicine PLLC

    Memphis, Tennessee, 38119

  • The Endocrine Clinic

    Memphis, Tennessee, 38119

  • Medical Research of Louisiana

    Metairie, Louisiana, 70002

  • University of Miami Diabetes Research Institute

    Miami, Florida, 33136

  • International Research Associates LLC

    Miami, Florida, 33156

  • Winthrop University Hospital

    Mineola, New York, 11501

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Center for Urologic Clinical Trials University of Minnesota

    Minneapolis, Minnesota, 55455

  • Coastal Clinical Research Inc

    Mobile, Alabama, 36608

  • North Shore Diabetes and Endocrine Associates

    New Hyde Park, New York, 11042

  • Sentara Medical Group

    Norfolk, Virginia, 23502

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Creighton Diabetes Center

    Omaha, Nebraska, 68131

  • Southern California Endocrine Center

    Pasadena, California, 91105

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Portland Diabetes & Endocrinology Center

    Portland, Oregon, 97210

  • New Hope Research of Oregon

    Portland, Oregon, 97219

  • Covance CRU Inc.

    Portland, Oregon, 97239

  • Rainier Clinical Research Center Inc

    Renton, Washington, 98055

  • Atlanta Center for Clinical Research

    Roswell, Georgia, 30075

  • KMED Research

    Saint Clair Shores, Michigan, 48081

  • Salt Lake Research

    Salt Lake City, Utah, 84107

  • Quality Assurance Research Center Inc

    San Antonio, Texas, 78205

  • Covenant Clinic Research

    San Antonio, Texas, 78229

  • Diabetes & Glandular Disease Research Assoc PA

    San Antonio, Texas, 78229

  • SAM Clinical Research Center

    San Antonio, Texas, 78229

  • Coastal Biomedical Research Inc

    Santa Monica, California, 90404

  • Clintell Inc

    Skokie, Illinois, 60076

  • Clintell Inc (Ellyin)

    Skokie, Illinois, 60077

  • MedEx Healthcare Research Inc

    St Louis, Missouri, 63117

  • Univeristy of Physicians Group Endocrine Division

    Staten Island, New York, 10301

  • Cedar Research

    Tacoma, Washington, 98405

  • Liberty Research Center

    Tacoma, Washington, 98405

  • Southeastern Research Associates Inc

    Taylors, South Carolina, 29687

  • James A Dicke MDPA

    Towson, Maryland, 21204

  • Quality of Life Medical & Research Center

    Tucson, Arizona, 85712

  • Southern Arizona VA Healthcare System

    Tucson, Arizona, 85723

  • Tucson Clinical Research

    Tucson, Arizona, 85741

  • Diabetes Research Center

    Tustin, California, 92780

Other trials in United States

Russia16 sites

  • NHI Kemerovo Regional Clinical Hospital

    Kemerovo, RUS, 650061

  • NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense

    Moscow, RUS, 105229

  • NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70

    Moscow, RUS, 111399

  • Moscow City Clinical Hospital # 13

    Moscow, RUS, 115280

  • SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology

    Moscow, RUS, 119435

  • SI Internal Affairs of Moscow- Clinical Hospital

    Moscow, RUS, 125299

  • RAAMS Endocrinology and Diabetology Department

    Moscow, RUS, 125315

  • NI Central Clinical Hospital of RAS

    Moscow, 117 593

  • City Clinical Hospital # 61

    Moscow, 119 048

  • St Petersburg NHI City Polytclinic #77 City Diabetological Center #4

    Saint Petersburg, RUS, 193012

  • Central Medical Sanitary Unit #122

    Saint Petersburg, RUS, 194291

  • Pavlov State Medical Univ of St Petersburg

    Saint Petersburg, RUS, 197022

  • NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital

    Smolensk, RUS, 214018

  • MHI Clinical Hospital for Emergency Care na NV Soloviev

    Yaroslavl, RUS, 150003

  • MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant

    Yaroslavl, RUS, 150023

  • NHI Yaroslavl Regional Clinical Hospital

    Yaroslavl, RUS, 150062

Other trials in Russia

Brazil12 sites

  • Universidade Estabual de Maringa

    Maringa Parana, 87020-900

  • Nucleo de Medicina Integrada

    Mogi das Cruzes, 08780-090

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione

    Rio de Janeiro, 20211-340

  • Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda

    Rio de Janeiro, 22271-100

  • Hospital Guilherme Alvaro

    Santos, 11045-904

  • CPClin-Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01244-030

  • Hospital do Rim e Hipertensao

    São Paulo, 04025-011

  • Instituto da Saude e Bem Estar da Mulher

    São Paulo, 04062-003

  • Blumenau Servicos Medicos S/C Ltda

    São Paulo, 05302-001

  • Centro de Pesquisa Clinica e Medicina Avancada

    São Paulo, 05437-010

Other trials in Brazil

Spain9 sites

  • Hospital del Mar (Cano)

    Barcelona, 08003

  • Centro Médico Teknon

    Barcelona, 08022

  • Hospital Universitario de la Princessa

    Madrid, 28006

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital de Mataro

    Mataró, Barcelona, 08304

  • Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia

    Sabadell, 08208

  • Complejo Hospitalario Nuestra Senora de Valme

    Seville, Andalusia, 41014

  • Complejo Hospitalario Virgen del Rocio

    Seville, 41013

  • Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion

    Seville, 41071

Other trials in Spain

Argentina7 sites

  • Hospital Interzonal de Agudos Pedro Fiorito

    Avellaneda, Buenos Aires, B1870ARG

  • FUNDAPRES/CIMel

    Buenos Aires, B1824KAJ

  • Centro Endocrinologic Tiempo

    Buenos Aires, C1117ABH

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • Cons Asoc de Endocrinologia

    Buenos Aires, C1425AGC

  • Centro Medico Dra De Salvo

    Buenos Aires, C1426ABP

  • CITDEEM - Centro de Investigacion y Tratamiento En Diabetes y Enfermedades Endocrino-Metabolicas

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Poland7 sites

  • Oddzial Chorob Wewnetrznych

    Bialystock, POL, 15-950

  • NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny

    Bialystok, POL, 15-435

  • Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego

    Krakow, POL, 31 501

  • Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, POL, 90 153

  • Instytut Centrum Zdrowia (009) Matki Polki

    Lodz, POL, 93-338

  • Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii

    Pruszków, POL, 05 800

  • NZOZ Diabetologiczna Poradnia Specjalistyczna

    Warsaw, 01-911

Other trials in Poland

Canada6 sites

  • Keele Medical Place

    Downsview, Ontario, M3M 3E5

  • Quest Clinical Trials

    Markham, Ontario, L6B 1A1

  • Lifestyle Metabolism Center

    Oakville, Ontario, L6H 3P1

  • Sarnia Institute of Clinical Research

    Sarnia, Ontario, N7T 4X3

  • Lifestyle Metabolism Center

    Thornhill, Ontario, L4J 8L7

  • Lifestyle Metabolism Center

    Toronto, Ontario, M4R 2G4

Other trials in Canada

Mexico6 sites

  • Hospital Santa Engracia-CIMA

    Garza García, 66260

  • Instituto Mexicano de Investigacion

    Mexico City, Durango, 06700

  • Centro de Estudios en Diabetes

    Mexico City, 01120

  • Cifbiotec

    Mexico City, CP14050

  • Hospital Universitario Dr Jose E Gonzalez

    Monterrey, Nuevo León, 64460

  • Hospital OCA

    Monterrey, Nuevo Leon, MX, 64000

Other trials in Mexico

Chile4 sites

  • Hospital del Salvador

    Santiago, Santiago Metropolitan

  • Hospital Padre Alberto Hurtado

    Santiago, Santiago Metropolitan

  • Hospital Clinico Pontificia Universidad Catolica de Chile

    Santiago

  • Hospital San Borja ArriaranUniversidad de Chile

    Santiago

Other trials in Chile

United Kingdom4 sites

  • Birchwood Surgery

    Letchworth Garden City, Herts, SG6 4UB

  • Guy's & St Thomas Hospital

    London, SE1 9RT

  • Yaxley Group Practice

    Peterborough, PE7 3JL

  • Lister Hospital

    Stevenage, Herts, SG1 4AB

Other trials in United Kingdom

About this study

Official title: A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere /Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

Conditions
Diabetes Type 2
Being tested
Technosphere® Insulin Inhalation Powder, 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
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.

  • Technosphere® Insulin Inhalation PowderDrug

    Inhalation, 15U/30U

  • 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)Drug

    BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

Study groups in NCT00309244
Study groupRoleWhat they receive
TI + Insulin glargineExperimentalTechnosphere® Insulin Inhalation Powder + insulin glargine
Receives: Drug: Technosphere® Insulin Inhalation Powder
BPR 70/30Active comparator70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
Receives: Drug: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

What is being measured

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

  1. Change From Baseline in HbA1c to Week 52

    Measured: Baseline to Week 52

Secondary outcomes (7)

  1. Change From Baseline in Weight to Week 52

    Measured: Baseline to Week 52

  2. Change From Baseline in Fasting Plasma Glucose to Week 52

    Measured: Baseline to Week 52

  3. Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%

    Measured: Week 52

  4. Incidence of Total Hypoglycemia

    Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.

    Measured: 52 Weeks

  5. Incidence of Severe Hypoglycemia

    Severe hypoglycemia occurs when all 3 of the following occur simultaneously:

    • Subject requires the assistance of another person;
    • Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);
    • Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,
    • Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms.

    Measured: 52 Weeks

  6. Total Hypoglycemia Event Rate

    Number of Hypoglycemic Events/Total Subject Exposure Time (in months)

    Measured: 52 Weeks

  7. Severe Hypoglycemia Event Rate

    Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)

    Measured: 52 Weeks

Timeline

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

  1. First posted31 Mar 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionAug 2008
  4. Study completionSep 2008

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
677 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00309244
Sponsor's protocol ID
MKC-TI-102
Status last verified
Oct 2014
First submitted
27 Mar 2006
Last updated
16 Oct 2014

Publications

  • Peyrot M, Rubin RR. Patient-reported outcomes in adults with type 2 diabetes using mealtime inhaled technosphere insulin and basal insulin versus premixed insulin. Diabetes Technol Ther. 2011 Dec;13(12):1201-6. doi: 10.1089/dia.2011.0037. Epub 2011 Oct 14.

    PubMed 21999640

  • Rosenstock J, Lorber DL, Gnudi L, Howard CP, Bilheimer DW, Chang PC, Petrucci RE, Boss AH, Richardson PC. Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial. Lancet. 2010 Jun 26;375(9733):2244-53. doi: 10.1016/S0140-6736(10)60632-0.

    PubMed 20609970

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Technosphere® Insulin Inhalation Powder and 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin) in people with Diabetes Type 2, run by Mannkind Corporation at 151 sites in 10 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 9 inclusion and 23 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 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, Russia, Brazil, Spain, Argentina and 5 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 16 Oct 2014). 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 to Week 52 (time frame: Baseline to Week 52). 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 NCT00309244, which also lists 2 linked publications.

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 16 Oct 2014.

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