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

October 9, 2014 updated by: Mannkind Corporation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

547

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
        • CIMEL
    • Buenos Aires
      • Avellaneda, Buenos Aires, Argentina, B1870ARG
        • Hospital Interzonal de Agudos Pedro Fiorito
  • Brazil
      • 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, 05437-010
        • Instituto de Pesquisa Clinica e Medicina Avancada
      • Sao Paulo, Brazil, 04025-011
        • Hospital Do Rim E Hipertensão
      • Sao Paulo, Brazil, 04020-050
        • UNIFRSP
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital São Lucas da PUCRS
  • Canada
      • Richmond Hill, Canada, L4C 9M7
        • Unimedico Management
    • Ontario
      • Markham, Ontario, Canada, L6B 1A1
        • Quest Clinical Trials
      • Oakville, Ontario, Canada, L6H 3P1
        • Lifestyle Metabolism Center
      • Thornhill, Ontario, Canada, L4J 8L7
        • Lifestyle Metabolism Center
      • Toronto, Ontario, Canada, M4R 2G4
        • Lifestyle Metabolism Center
      • Toronto, Ontario, Canada, M4T 1N5
        • Trial Management Group Inc (Henein
  • Chile
      • Santiago, Chile
        • Instituto de Informacion de Tramiento y Educacion en Salud
      • Santiago, Chile
        • Hospital Clínico Pontificia Universidad Católica de Chile
      • Santiago, Chile
        • Hospital del Salvador
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile
        • Hospital Padre Alberto Hurtado
  • Czech Republic
      • Ostrava, Czech Republic, 70200
        • Diabetologicka ambulance (Chmura)
      • Ostrava, Czech Republic, 70900
        • Interní a diabetologická Outpatient
      • Praha 1, Czech Republic, 11694
        • Endokrinologicky ustav
      • Praha 10, Czech Republic, 10034
        • II interni klinika FN Kralovske Vinohrady
      • Praha 2, Czech Republic, 12801
        • 3rd Medical Department General Faculty Hospital
    • CZE
      • Ostrava-Kuncice, CZE, Czech Republic, 70702
        • Diabetologicka a interni ambulance
      • Prague 4, CZE, Czech Republic, 140 21
        • Institute for Clinical and Exp Medicine
      • Prague 8, CZE, Czech Republic, 180 81
        • University Hospital Na Bulovce
  • Mexico
      • Garza Garcia, Mexico, 66260
        • Hospital Santa Engracia-CIMA
      • Mexico City, Mexico, 01120
        • Centro de Estudios en Diabetes
      • Mexico City, Mexico, 06726
        • Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio
      • Monterrey, Mexico, 64020
        • OCA-MIRC
    • Durango
      • Mexico City, Durango, Mexico, 06700
        • Instituto Mexicano de Investigacion
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario Dr Jose E Gonzalez
  • Poland
      • Lodz, Poland, 90-153
        • Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
      • Warsaw, Poland, 03 580
        • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
      • Warszawa, Poland, 02 777
        • Centrum Leczenia Chorob Cywilizacyjnych
    • POL
      • Bialystock, POL, Poland, 15-276
        • Klinika Endocrinologii Diabetologii I
      • 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
      • Pruszkow, POL, Poland, 05-800
        • Spzital Kolejowy imm Wlodzimierza Roeflera
  • Russian Federation
      • 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, 115478
        • NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
      • Moscow, RUS, Russian Federation, 129110
        • NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
      • 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, 198013
        • TUV Medico-Military Academy
      • St. Petersburg, RUS, Russian Federation, 194354
        • St Petersburg NHI Municipal Multi-Speciality Hospital # 2
      • Yaroslavl, RUS, Russian Federation, 150003
        • MHI Clinical Hospital for Emergency Care na NV Soloviev
      • Yaroslavl, RUS, Russian Federation, 150062
        • NHI Yaroslavl Regional Clinical Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • 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
    • Andalucia
      • Sevilla, Andalucia, Spain, 41014
        • Complejo Hospitalario Nuestra Senora de Valme
  • Ukraine
      • Kiev, Ukraine, 02147
        • Outpatient Clinic of Family Physician "Rusanovka"
      • Odessa, Ukraine, 65114
        • Public Institution City Policlinic #20 Odessa
    • UKR
      • Chernivtsy, UKR, Ukraine, 58022
        • Bukovinian State Medical University Dept of Clinical Immun
      • Dniepropetrovsk, UKR, Ukraine, 49023
        • Dniepropetrovsh State Medical Academy
      • Donetsk, UKR, Ukraine, 83003
        • Donetsk State Medical University
      • Donetsk, UKR, Ukraine, 83114
        • Railway Clinical Hospital on Donetsk Station
      • Donetsk, UKR, Ukraine, 83099
        • Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin)
      • Kiev, UKR, Ukraine, 04050
        • Chair Family Med of National Med University
      • Kiev, UKR, Ukraine, 04114
        • Institute of Endocrinology and Metabolism
      • Kiev, UKR, Ukraine, 2175
        • Ukr Scientifically Practical Centre of Endocrine Surgery
      • Odessa, UKR, Ukraine, 65009
        • Odessa State Medical University Dept of Gen Practice and Med Rehab
      • Odessa, UKR, Ukraine, 65025
        • Odessa Reg. Clinical Hosp Outpatient Department
      • Odessa, UKR, Ukraine, 65039
        • Odessa State Med Dept of Family Med and Gen Practice
      • Vinnitsa, UKR, Ukraine, 21010
        • Vinnitsa State Medical University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
      • Birmingham, Alabama, United States, 35209
        • Radiant Research-Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85029
        • Redpoint Research
      • Phoenix, Arizona, United States, 85032
        • Arizona Center For Clinical Research
    • California
      • Chula Vista, California, United States, 91911
        • International Clinical Research Network
    • Colorado
      • Denver, Colorado, United States, 80209
        • Creekside Endocrine Associates
      • Denver, Colorado, United States, 80206
        • National Jewish Medical & Research Center
      • Denver, Colorado, United States, 80220
        • Jennifer Hone MD
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Hollywood, Florida, United States, 33021
        • Center for Diabetes & Endocrine Care
      • Miami, Florida, United States, 33156
        • International Research Associates LLC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stoger Jr Hospital of Cook County
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
      • Skokie, Illinois, United States, 60076
        • Clintell Inc
    • Maryland
      • Towson, Maryland, United States, 21204
        • James A Dicke MDPA
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
        • East Coast Clinical Research Inc
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Livonia, Michigan, United States, 48152
        • Michigan Institute of Medicine
    • Missouri
      • St Louis, Missouri, United States, 63117
        • Clayton Medical Research
      • St Louis, Missouri, United States, 63141
        • Raidant Research-St Louis
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton Diabetes Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resources (Albuquerque)
    • 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
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Metrolina Internal Medicine
      • Charlotte, North Carolina, United States, 28277
        • Sensenbrenner Primary Care
      • Charlotte, North Carolina, United States, 28211
        • Charlotte Clinical Research Inc
      • Durham, North Carolina, United States, 27710
        • Duke Medical Center
    • Ohio
      • Dayton, Ohio, United States, 45406
        • Dayton Clinical Research
      • Dayton, Ohio, United States, 45439
        • Providence Health Partners - Center of Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97239
        • Radiant Research
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Upstate Pharmaceutical Research
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Collierville Medical Specialists
      • Memphis, Tennessee, United States, 38119
        • Memphis Internal Medicine (Kathawala)
      • Memphis, Tennessee, United States, 38120
        • GoodLife Medical Center PLLC
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Endocrine Center
      • 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, 78229
        • Clinical Trials of Texas Inc
      • San Antonio, Texas, United States, 78205
        • Quality Assurance Research Center Inc
      • San Antonio, Texas, United States, 78229
        • Covenant Clinic Research
    • Washington
      • Tacoma, Washington, United States, 98405
        • Cedar Research

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:

  • 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%

Exclusion Criteria:

  • 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)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Technosphere Insulin
Drug: Technosphere Insulin
Inhalation, 15U/30U, prandial
Active Comparator: 2
Metformin & Secretagogues
Drug: Metformin & Secretagogues
Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
Experimental: 3
Technosphere & Metformin
Drug: Technosphere Insulin & Metformin
Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue
Time Frame: Baseline to Week 12
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue
Time Frame: Baseline to Week 12
(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)
Baseline to Week 12
Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)
Time Frame: Week 24
Week 24

Collaborators and Investigators

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

Sponsor

Mannkind Corporation

Investigators

  • Study Director: For MannKind sponsored trials, the Overall Study Official is the Chief Scientific Officer, Mannkind Corporation

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

December 1, 2004

Primary Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 31, 2006

First Submitted That Met QC Criteria

May 31, 2006

First Posted (Estimate)

June 1, 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-103

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Technosphere Insulin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe