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Diabetes Mellitus, Type 2Phase 3NCT00332488

Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

A Phase 3 study testing Technosphere Insulin, Metformin & Secretagogues and Technosphere Insulin & Metformin in people with Diabetes Mellitus, Type 2, run by Mannkind Corporation at 120 sites in 11 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

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Technosphere Insulin, Metformin & Secretagogues and Technosphere Insulin & Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
547 participants
Where
120 sitesin 11 countries
Study dates
Dec 2004to Mar 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

  • Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months
  • Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
  • Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
  • HbA1c >or= to 7.5% and < or= to 11.0%
  • BMI < or = to 40kg/m2.
  • FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%

Who cannot join

  • Treatment with any type of anti-diabetic therapy, other than metformin \& secretagogues within the preceding 12 weeks
  • Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects
  • History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
  • Evidence of serious complications of diabetes (e.g. autonomic neuropathy)

Trial locations and contacts

120 sites in 11 countries.

120 sites in 11 countries

United States43 sites

  • Lovelace Scientific Resources (Albuquerque)

    Albuquerque, New Mexico, 87108

  • Radiant Research-Birmingham

    Birmingham, Alabama, 35209

  • Parkway Medical Center

    Birmingham, Alabama, 35215

  • Metrolina Internal Medicine

    Charlotte, North Carolina, 28204

  • Charlotte Clinical Research Inc

    Charlotte, North Carolina, 28211

  • Sensenbrenner Primary Care

    Charlotte, North Carolina, 28277

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • John H Stoger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • International Clinical Research Network

    Chula Vista, California, 91911

  • Collierville Medical Specialists

    Collierville, Tennessee, 38017

  • Baylor Endocrine Center

    Dallas, Texas, 75246

  • Dayton Clinical Research

    Dayton, Ohio, 45406

  • Providence Health Partners - Center of Clinical Research

    Dayton, Ohio, 45439

  • National Jewish Medical & Research Center

    Denver, Colorado, 80206

  • Creekside Endocrine Associates

    Denver, Colorado, 80209

  • Jennifer Hone MD

    Denver, Colorado, 80220

  • Wayne State University

    Detroit, Michigan, 48201

  • Duke Medical Center

    Durham, North Carolina, 27710

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • East Coast Clinical Research Inc

    Haverhill, Massachusetts, 01830

  • Center for Diabetes & Endocrine Care

    Hollywood, Florida, 33021

  • Michigan Institute of Medicine

    Livonia, Michigan, 48152

  • Memphis Internal Medicine (Kathawala)

    Memphis, Tennessee, 38119

  • GoodLife Medical Center PLLC

    Memphis, Tennessee, 38120

  • International Research Associates LLC

    Miami, Florida, 33156

  • Winthrop University Hospital

    Mineola, New York, 11501

  • North Shore Diabetes and Endocrine Associates

    New Hyde Park, New York, 11042

  • Creighton Diabetes Center

    Omaha, Nebraska, 68131

  • Redpoint Research

    Phoenix, Arizona, 85029

  • Arizona Center for Clinical Research

    Phoenix, Arizona, 85032

  • Radiant Research

    Portland, Oregon, 97239

  • Quality Assurance Research Center Inc

    San Antonio, Texas, 78205

  • Clinical Trials of Texas Inc

    San Antonio, Texas, 78229

  • 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

  • Clintell Inc

    Skokie, Illinois, 60076

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Clayton Medical Research

    St Louis, Missouri, 63117

  • Raidant Research-St Louis

    St Louis, Missouri, 63141

  • Cedar Research

    Tacoma, Washington, 98405

  • James A Dicke MDPA

    Towson, Maryland, 21204

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

Other trials in United States

Ukraine14 sites

  • Bukovinian State Medical University Dept of Clinical Immun

    Chernivtsy, UKR, 58022

  • Dniepropetrovsh State Medical Academy

    Dniepropetrovsk, UKR, 49023

  • Donetsk State Medical University

    Donetsk, UKR, 83003

  • Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin)

    Donetsk, UKR, 83099

  • Railway Clinical Hospital on Donetsk Station

    Donetsk, UKR, 83114

  • Chair Family Med of National Med University

    Kiev, UKR, 04050

  • Institute of Endocrinology and Metabolism

    Kiev, UKR, 04114

  • Ukr Scientifically Practical Centre of Endocrine Surgery

    Kiev, UKR, 2175

  • Outpatient Clinic of Family Physician "Rusanovka"

    Kiev, 02147

  • Odessa State Medical University Dept of Gen Practice and Med Rehab

    Odesa, UKR, 65009

  • Odessa Reg. Clinical Hosp Outpatient Department

    Odesa, UKR, 65025

  • Odessa State Med Dept of Family Med and Gen Practice

    Odesa, UKR, 65039

  • Public Institution City Policlinic #20 Odessa

    Odesa, 65114

  • Vinnitsa State Medical University

    Vinnitsa, UKR, 21010

Other trials in Ukraine

Russia13 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

  • NI Endrocrinological Research Centre of RAMS In patient replacing technologies department

    Moscow, RUS, 115478

  • NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky

    Moscow, RUS, 129110

  • NI Central Clinical Hospital of RAS

    Moscow, 117 593

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

    Saint Petersburg, RUS, 193012

  • Central Medical Sanitary Unit #122

    Saint Petersburg, RUS, 194291

  • St Petersburg NHI Municipal Multi-Speciality Hospital # 2

    Saint Petersburg, RUS, 194354

  • TUV Medico-Military Academy

    Saint Petersburg, RUS, 198013

  • 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

  • NHI Yaroslavl Regional Clinical Hospital

    Yaroslavl, RUS, 150062

Other trials in Russia

Brazil8 sites

  • 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

  • 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, 01244-030

  • UNIFRSP

    São Paulo, 04020-050

  • Hospital do Rim e Hipertensao

    São Paulo, 04025-011

  • Instituto de Pesquisa Clinica e Medicina Avancada

    São Paulo, 05437-010

Other trials in Brazil

Czechia8 sites

  • Interní a diabetologická Outpatient

    Ostrava, Ostrava, 70900

  • Diabetologicka ambulance (Chmura)

    Ostrava, 70200

  • Diabetologicka a interni ambulance

    Ostrava-Kunčice, CZE, 70702

  • Institute for Clinical and Exp Medicine

    Prague, CZE, 140 21

  • University Hospital Na Bulovce

    Prague, CZE, 180 81

  • II interni klinika FN Kralovske Vinohrady

    Prague, 10034

  • Endokrinologicky ustav

    Prague, 11694

  • 3rd Medical Department General Faculty Hospital

    Prague, 12801

Other trials in Czechia

Poland8 sites

  • Klinika Endocrinologii Diabetologii I

    Bialystock, POL, 15-276

  • NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny

    Bialystok, POL, 15-435

  • Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego

    Krakow, POL, 31 501

  • Instytut Centrum Zdrowia (009) Matki Polki

    Lodz, POL, 93-338

  • Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego

    Lodz, 90-153

  • Spzital Kolejowy imm Wlodzimierza Roeflera

    Pruszków, POL, 05-800

  • Centrum Leczenia Chorob cywilizacyjnych

    Warsaw, 02 777

  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

    Warsaw, 03 580

Other trials in Poland

Canada6 sites

  • Quest Clinical Trials

    Markham, Ontario, L6B 1A1

  • Lifestyle Metabolism Center

    Oakville, Ontario, L6H 3P1

  • Unimedico Management

    Richmond Hill, L4C 9M7

  • Lifestyle Metabolism Center

    Thornhill, Ontario, L4J 8L7

  • Lifestyle Metabolism Center

    Toronto, Ontario, M4R 2G4

  • Trial Management Group Inc (Henein

    Toronto, Ontario, M4T 1N5

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

  • Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio

    Mexico City, 06726

  • Hospital Universitario Dr Jose E Gonzalez

    Monterrey, Nuevo León, 64460

  • OCA-MIRC

    Monterrey, 64020

Other trials in Mexico

Argentina5 sites

  • Hospital Interzonal de Agudos Pedro Fiorito

    Avellaneda, Buenos Aires, B1870ARG

  • Centro Endocrinologic Tiempo

    Buenos Aires, C1117ABH

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • Cons Asoc de Endocrinologia

    Buenos Aires, C1425AGC

  • CIMeL

    Buenos Aires

Other trials in Argentina

Spain5 sites

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Hospital Universitario de la Princessa

    Madrid, 28006

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia

    Sabadell, 08208

  • Complejo Hospitalario Nuestra Senora de Valme

    Seville, Andalusia, 41014

Other trials in Spain

Chile4 sites

  • Hospital Padre Alberto Hurtado

    Santiago, Santiago Metropolitan

  • Hospital Clinico Pontificia Universidad Catolica de Chile

    Santiago

  • Hospital del Salvador

    Santiago

  • Instituto de Informacion de Tramiento y Educacion en Salud

    Santiago

Other trials in Chile

About this study

Official title: A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Being tested
Technosphere Insulin, Metformin & Secretagogues, Technosphere Insulin & Metformin
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 InsulinDrug

    Inhalation, 15U/30U, prandial

  • Metformin & SecretagoguesDrug

    Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.

  • Technosphere Insulin & MetforminDrug

    Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Study groups in NCT00332488
Study groupRoleWhat they receive
1ExperimentalTechnosphere Insulin
Receives: Drug: Technosphere Insulin
2Active comparatorMetformin \& Secretagogues
Receives: Drug: Metformin & Secretagogues
3ExperimentalTechnosphere \& Metformin
Receives: Drug: Technosphere Insulin & Metformin

What is being measured

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

  1. Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue

    Measured: Baseline to Week 12

Secondary outcomes (2)

  1. Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue

    (Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)

    Measured: Baseline to Week 12

  2. Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)

    Measured: Week 24

Timeline

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

  1. First posted1 Jun 2006 (estimated)
  2. Study startDec 2004
  3. Primary completionMar 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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
547 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00332488
Sponsor's protocol ID
MKC-TI-103
Status last verified
Oct 2014
First submitted
31 May 2006
Last updated
16 Oct 2014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Technosphere Insulin, Metformin & Secretagogues and Technosphere Insulin & Metformin in people with Diabetes Mellitus, Type 2, run by Mannkind Corporation at 120 sites in 11 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 6 inclusion and 4 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 120 sites in United States, Ukraine, Russia, Brazil, Czechia and 6 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?

Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue (time frame: Baseline to Week 12). 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 NCT00332488.

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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