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

October 9, 2014 updated by: Mannkind Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

677

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1117ABH
        • Centro Endocrinologic Tiempo
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1425AGC
        • Cons Asoc de Endocrinologia
      • Buenos Aires, Argentina, C1426ABP
        • Centro Médico Dra de Salvo
      • Buenos Aires, Argentina, B1824KAJ
        • FUNDAPRES/CIMel
    • Buenos Aires
      • Avellaneda, Buenos Aires, Argentina, B1870ARG
        • Hospital Interzonal de Agudos Pedro Fiorito
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • CITDEEM - Centro de Investigacion y Tratamiento En Diabetes y Enfermedades Endocrino-Metabolicas
  • Brazil
      • Maringa Parana, Brazil, 87020-900
        • Universidade Estabual de Maringa
      • Mogi das Cruzes, Brazil, 08780-090
        • Nucleo de Medicina Integrada
      • Rio de Janeiro, Brazil, 20211-340
        • Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione
      • Rio de Janeiro, Brazil, 22271-100
        • CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
      • Santos, Brazil, 11045-904
        • Hospital Guilherme Alvaro
      • Sao Paulo, Brazil, 01244-030
        • CPClin-Centro de Pesquisas Clinicas
      • Sao Paulo, Brazil, 05302-001
        • Blumenau Servicos Medicos S/C Ltda
      • Sao Paulo, Brazil, 04025-011
        • Hospital do Rim e Hipertensao
      • Sao Paulo, Brazil, 04062-003
        • Instituto da Saude e Bem Estar da Mulher
      • Sao Paulo, Brazil, 05437-010
        • Centro de Pesquisa Clinica e Medicina Avancada
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital São Lucas da PUCRS
  • Canada
    • Ontario
      • Downsview, Ontario, Canada, M3M 3E5
        • Keele Medical Place
      • Markham, Ontario, Canada, L6B 1A1
        • Quest Clinical Trials
      • Oakville, Ontario, Canada, L6H 3P1
        • Lifestyle Metabolism Center
      • Sarnia, Ontario, Canada, N7T 4X3
        • Sarnia Institute of Clinical Research
      • Thornhill, Ontario, Canada, L4J 8L7
        • Lifestyle Metabolism Center
      • Toronto, Ontario, Canada, M4R 2G4
        • Lifestyle Metabolism Center
  • Chile
      • Santiago, Chile
        • Hospital San Borja ArriaranUniversidad de Chile
      • Santiago, Chile
        • Hospital Clínico Pontificia Universidad Católica de Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile
        • Hospital del Salvador
      • Santiago, Region Metropolitana, Chile
        • Hospital Padre Alberto Hurtado
  • Mexico
      • Garza Garcia, Mexico, 66260
        • Hospital Santa Engracia-CIMA
      • Mexico City, Mexico, 01120
        • Centro de Estudios en Diabetes
      • Mexico City, Mexico, CP14050
        • Cifbiotec
    • Durango
      • Mexico City, Durango, Mexico, 06700
        • Instituto Mexicano de Investigacion
    • MX
      • Monterrey, Nuevo Leon, MX, Mexico, 64000
        • Hospital OCA
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario Dr Jose E Gonzalez
  • Poland
      • Warszawa, Poland, 01-911
        • NZOZ Diabetologiczna Poradnia Specjalistyczna
    • POL
      • Bialystock, POL, Poland, 15-950
        • Oddzial Chorob Wewnetrznych
      • Bialystok, POL, Poland, 15-435
        • NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
      • Krakow, POL, Poland, 31 501
        • Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
      • Lodz, POL, Poland, 93-338
        • Instytut Centrum Zdrowia (009) Matki Polki
      • Lodz, POL, Poland, 90 153
        • Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
      • Pruszkow, POL, Poland, 05 800
        • Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii
  • Russian Federation
      • Moscow, Russian Federation, 119 048
        • City Clinical Hospital # 61
      • Moscow, Russian Federation, 117 593
        • NI Central Clinical Hospital of RAS
    • RUS
      • Kemerovo, RUS, Russian Federation, 650061
        • NHI Kemerovo Regional Clinical Hospital
      • Moscow, RUS, Russian Federation, 105229
        • NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
      • Moscow, RUS, Russian Federation, 111399
        • NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
      • Moscow, RUS, Russian Federation, 115280
        • Moscow City Clinical Hospital # 13
      • Moscow, RUS, Russian Federation, 119435
        • SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
      • Moscow, RUS, Russian Federation, 125299
        • SI Internal Affairs of Moscow- Clinical Hospital
      • Moscow, RUS, Russian Federation, 125315
        • RAAMS Endocrinology and Diabetology Department
      • Smolensk, RUS, Russian Federation, 214018
        • NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
      • St Petersburg, RUS, Russian Federation, 193012
        • St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
      • St Petersburg, RUS, Russian Federation, 194291
        • Central Medical Sanitary Unit #122
      • St Petersburg, RUS, Russian Federation, 197022
        • Pavlov State Medical Univ of St Petersburg
      • Yaroslavl, RUS, Russian Federation, 150003
        • MHI Clinical Hospital for Emergency Care na NV Soloviev
      • Yaroslavl, RUS, Russian Federation, 150023
        • MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
      • Yaroslavl, RUS, Russian Federation, 150062
        • NHI Yaroslavl Regional Clinical Hospital
  • Spain
      • Barcelona, Spain, 08022
        • Centro Medico Teknon
      • Barcelona, Spain, 08003
        • Hospital del Mar (Cano)
      • Madrid, Spain, 28034
        • Hospital Ramón Y Cajal
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princessa
      • Sabadell, Spain, 08208
        • Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia
      • Sevilla, Spain, 41013
        • Complejo Hospitalario Virgen del Rocío
      • Sevilla, Spain, 41071
        • Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion
    • Andalucia
      • Sevilla, Andalucia, Spain, 41014
        • Complejo Hospitalario Nuestra Senora de Valme
    • Barcelona
      • Mataro, Barcelona, Spain, 08304
        • Hospital de Mataró
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's & St Thomas Hospital
      • Peterborough, United Kingdom, PE7 3JL
        • Yaxley Group Practice
    • Herts
      • Letchworth, Herts, United Kingdom, SG6 4UB
        • Birchwood Surgery
      • Stevenage, Herts, United Kingdom, SG1 4AB
        • Lister Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research Inc
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Quality of Life Medical & Research Center
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Healthcare System
      • Tucson, Arizona, United States, 85741
        • Tucson Clinical Research
    • California
      • Chula Vista, California, United States, 91911
        • International Clinical Research Network
      • Fresno, California, United States, 93720
        • Valley Research
      • Fresno, California, United States, 93710
        • Saad Hijazi MD Inc
      • Huntington Beach, California, United States, 92648
        • Diabetes/Lipid Management and Research Center
      • Inglewood, California, United States, 90301
        • South Bay Clinical Research
      • Pasadena, California, United States, 91105
        • Southern California Endocrine Center
      • Santa Monica, California, United States, 90404
        • Coastal Biomedical Research Inc
      • Tustin, California, United States, 92780
        • Diabetes Research Center
    • Florida
      • Miami, Florida, United States, 33156
        • International Research Associates LLC
      • Miami, Florida, United States, 33136
        • University of Miami Diabetes Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Laureate Clinical Research Group
      • Dunwoody, Georgia, United States, 30338
        • Atlanta Pharmaceutical Research Center
      • Lawrenceville, Georgia, United States, 30045
        • North Atlanta Endocrinology & Diabetes PC
      • Roswell, Georgia, United States, 30075
        • Atlanta Center for Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stoger Jr Hospital of Cook County
      • Skokie, Illinois, United States, 60076
        • Clintell Inc
      • Skokie, Illinois, United States, 60077
        • Clintell Inc (Ellyin)
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Medical Research of Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Joslin Diabetes Center University of Maryland Medicine
      • Towson, Maryland, United States, 21204
        • James A Dicke MDPA
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Livonia, Michigan, United States, 48152
        • Michigan Institute of Medicine
      • St Clair Shores, Michigan, United States, 48081
        • KMED Research
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Radiant Research Inc (Minneapolis)
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
      • Minneapolis, Minnesota, United States, 55455
        • Center for Urologic Clinical Trials University of Minnesota
    • Missouri
      • St Louis, Missouri, United States, 63117
        • Medex Healthcare Research Inc
      • St Peters, Missouri, United States, 63376
        • Amin Radparvar's Private Practice
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Research Division
      • Billings, Montana, United States, 59102
        • Montana Health Research Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton Diabetes Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico HCS
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Clinical Research & Osteoporosis Center
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11042
        • North Shore Diabetes and Endocrine Associates
      • Staten Island, New York, United States, 10301
        • Univeristy of Physicians Group Endocrine Division
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Sensenbrenner Primary Care
      • Greenville, North Carolina, United States, 27834
        • Physician's East PA
      • Greenville, North Carolina, United States, 27834
        • East Carolina University (Tanenberg)
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Valley Medical Primary Care
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Dayton, Ohio, United States, 45439
        • Providence Health Partners - Center of Clinical Research
      • East Cleveland, Ohio, United States, 44112
        • Cleveland Clinic Health System
      • Kettering, Ohio, United States, 45429
        • Wells Institute for Health Awareness
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Medical Group Clinical Resesarch
      • Eugene, Oregon, United States, 97404
        • Lane Medical Research Group
      • Portland, Oregon, United States, 97210
        • Portland Diabetes & Endocrinology Center
      • Portland, Oregon, United States, 97239
        • Covance CRU Inc.
      • Portland, Oregon, United States, 97219
        • New Hope Research of Oregon
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Pennsylvania Research Institute
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Upstate Pharmaceutical Research
      • Taylors, South Carolina, United States, 29687
        • Southeastern Research Associates Inc
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • AM Diabetes And Endocrinology Center
      • Memphis, Tennessee, United States, 38119
        • The Endocrine Clinic
      • Memphis, Tennessee, United States, 38119
        • Memphis Internal Medicine PLLC
    • Texas
      • Arlington, Texas, United States, 76014
        • Israel Hartman MD
      • Arlington, Texas, United States, 76017
        • South Arlington Primary Care Assoc PA
      • Dallas, Texas, United States, 75231
        • Radiant Research Dallas-North
      • Dallas, Texas, United States, 75251
        • Galenos Research
      • Dallas, Texas, United States, 75246
        • Baylor Endocrine Center
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes & Endocrine Center
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Friendswood, Texas, United States, 77546
        • Spuhler Medical Associates
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Research Assoc PA
      • San Antonio, Texas, United States, 78229
        • Sam Clinical Research Center
      • San Antonio, Texas, United States, 78205
        • Quality Assurance Research Center Inc
      • San Antonio, Texas, United States, 78229
        • Covenant Clinic Research
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake Research
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater
      • Norfolk, Virginia, United States, 23502
        • Sentara Medical Group
    • Washington
      • Federal Way, Washington, United States, 98003
        • Larry D Stonesifer MD Inc PS
      • Renton, Washington, United States, 98055
        • Rainier Clinical Research Center Inc
      • Tacoma, Washington, United States, 98405
        • Cedar Research
      • Tacoma, Washington, United States, 98405
        • Liberty Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TI + Insulin glargine
Technosphere® Insulin Inhalation Powder + insulin glargine
Drug: Technosphere® Insulin Inhalation Powder
Inhalation, 15U/30U
Active Comparator: BPR 70/30
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
Drug: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in HbA1c to Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Weight to Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Change From Baseline in Fasting Plasma Glucose to Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
Time Frame: Week 52
Week 52
Incidence of Total Hypoglycemia
Time Frame: 52 Weeks
Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.
52 Weeks
Incidence of Severe Hypoglycemia
Time Frame: 52 Weeks

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.
52 Weeks
Total Hypoglycemia Event Rate
Time Frame: 52 Weeks
Number of Hypoglycemic Events/Total Subject Exposure Time (in months)
52 Weeks
Severe Hypoglycemia Event Rate
Time Frame: 52 Weeks
Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)
52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mannkind Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 29, 2006

First Posted (Estimate)

March 31, 2006

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-TI-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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