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

NCT00332488 | Completed Phase 3 Results

• 1 other identifier: MKC-TI-103
• Study Type: interventional
• Target: 547
• Locations: 11 countries
• Sites: 120

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 12

Secondary Outcomes (2)

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

  Baseline to Week 12

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

  Week 24

Study Arms (3)

1

EXPERIMENTAL

Technosphere Insulin

Drug: Technosphere Insulin

2

ACTIVE COMPARATOR

Metformin \& Secretagogues

Drug: Metformin & Secretagogues

3

EXPERIMENTAL

Technosphere \& Metformin

Drug: Technosphere Insulin & Metformin

Interventions

Technosphere Insulin DRUG

Inhalation, 15U/30U, prandial

1

Metformin & Secretagogues DRUG

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

2

Technosphere Insulin & Metformin DRUG

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

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (120)

Radiant Research-Birmingham

Birmingham, Alabama, 35209, United States

Location

Parkway Medical Center

Birmingham, Alabama, 35215, United States

Location

Redpoint Research

Phoenix, Arizona, 85029, United States

Location

Arizona Center for Clinical Research

Phoenix, Arizona, 85032, United States

Location

International Clinical Research Network

Chula Vista, California, 91911, United States

Location

National Jewish Medical & Research Center

Denver, Colorado, 80206, United States

Location

Creekside Endocrine Associates

Denver, Colorado, 80209, United States

Location

Jennifer Hone MD

Denver, Colorado, 80220, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Center for Diabetes & Endocrine Care

Hollywood, Florida, 33021, United States

Location

International Research Associates LLC

Miami, Florida, 33156, United States

Location

Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States

Location

John H Stoger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Clintell Inc

Skokie, Illinois, 60076, United States

Location

James A Dicke MDPA

Towson, Maryland, 21204, United States

Location

East Coast Clinical Research Inc

Haverhill, Massachusetts, 01830, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Michigan Institute of Medicine

Livonia, Michigan, 48152, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Clayton Medical Research

St Louis, Missouri, 63117, United States

Location

Raidant Research-St Louis

St Louis, Missouri, 63141, United States

Location

Creighton Diabetes Center

Omaha, Nebraska, 68131, United States

Location

Lovelace Scientific Resources (Albuquerque)

Albuquerque, New Mexico, 87108, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, 11042, United States

Location

Metrolina Internal Medicine

Charlotte, North Carolina, 28204, United States

Location

Charlotte Clinical Research Inc

Charlotte, North Carolina, 28211, United States

Location

Sensenbrenner Primary Care

Charlotte, North Carolina, 28277, United States

Location

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

Providence Health Partners - Center of Clinical Research

Dayton, Ohio, 45439, United States

Location

Radiant Research

Portland, Oregon, 97239, United States

Location

Upstate Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

Collierville Medical Specialists

Collierville, Tennessee, 38017, United States

Location

Memphis Internal Medicine (Kathawala)

Memphis, Tennessee, 38119, United States

Location

GoodLife Medical Center PLLC

Memphis, Tennessee, 38120, United States

Location

Baylor Endocrine Center

Dallas, Texas, 75246, United States

Location

Quality Assurance Research Center Inc

San Antonio, Texas, 78205, United States

Location

Clinical Trials of Texas Inc

San Antonio, Texas, 78229, United States

Location

Covenant Clinic Research

San Antonio, Texas, 78229, United States

Location

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, 78229, United States

Location

SAM Clinical Research Center

San Antonio, Texas, 78229, United States

Location

Cedar Research

Tacoma, Washington, 98405, United States

Location

Hospital Interzonal de Agudos Pedro Fiorito

Avellaneda, Buenos Aires, B1870ARG, Argentina

Location

Centro Endocrinologic Tiempo

Buenos Aires, C1117ABH, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Cons Asoc de Endocrinologia

Buenos Aires, C1425AGC, Argentina

Location

CIMeL

Buenos Aires, Argentina

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Sao Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda

Rio de Janeiro, 22271-100, Brazil

Location

Hospital Guilherme Alvaro

Santos, 11045-904, Brazil

Location

CPClin-Centro de Pesquisas Clinicas

São Paulo, 01244-030, Brazil

Location

UNIFRSP

São Paulo, 04020-050, Brazil

Location

Hospital do Rim e Hipertensao

São Paulo, 04025-011, Brazil

Location

Instituto de Pesquisa Clinica e Medicina Avancada

São Paulo, 05437-010, Brazil

Location

Quest Clinical Trials

Markham, Ontario, L6B 1A1, Canada

Location

Lifestyle Metabolism Center

Oakville, Ontario, L6H 3P1, Canada

Location

Lifestyle Metabolism Center

Thornhill, Ontario, L4J 8L7, Canada

Location

Lifestyle Metabolism Center

Toronto, Ontario, M4R 2G4, Canada

Location

Trial Management Group Inc (Henein

Toronto, Ontario, M4T 1N5, Canada

Location

Unimedico Management

Richmond Hill, L4C 9M7, Canada

Location

Hospital Padre Alberto Hurtado

Santiago, Santiago Metropolitan, Chile

Location

Hospital Clinico Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

Hospital del Salvador

Santiago, Chile

Location

Instituto de Informacion de Tramiento y Educacion en Salud

Santiago, Chile

Location

Diabetologicka a interni ambulance

Ostrava-Kunčice, CZE, 70702, Czechia

Location

Institute for Clinical and Exp Medicine

Prague, CZE, 140 21, Czechia

Location

University Hospital Na Bulovce

Prague, CZE, 180 81, Czechia

Location

Interní a diabetologická Outpatient

Ostrava, Ostrava, 70900, Czechia

Location

Diabetologicka ambulance (Chmura)

Ostrava, 70200, Czechia

Location

II interni klinika FN Kralovske Vinohrady

Prague, 10034, Czechia

Location

Endokrinologicky ustav

Prague, 11694, Czechia

Location

3rd Medical Department General Faculty Hospital

Prague, 12801, Czechia

Location

Instituto Mexicano de Investigacion

Mexico City, Durango, 06700, Mexico

Location

Hospital Universitario Dr Jose E Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Hospital Santa Engracia-CIMA

Garza García, 66260, Mexico

Location

Centro de Estudios en Diabetes

Mexico City, 01120, Mexico

Location

Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio

Mexico City, 06726, Mexico

Location

OCA-MIRC

Monterrey, 64020, Mexico

Location

Klinika Endocrinologii Diabetologii I

Bialystock, POL, 15-276, Poland

Location

NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny

Bialystok, POL, 15-435, Poland

Location

Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego

Krakow, POL, 31 501, Poland

Location

Instytut Centrum Zdrowia (009) Matki Polki

Lodz, POL, 93-338, Poland

Location

Spzital Kolejowy imm Wlodzimierza Roeflera

Pruszków, POL, 05-800, Poland

Location

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

Lodz, 90-153, Poland

Location

Centrum Leczenia Chorob cywilizacyjnych

Warsaw, 02 777, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

Warsaw, 03 580, Poland

Location

NHI Kemerovo Regional Clinical Hospital

Kemerovo, RUS, 650061, Russia

Location

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

Moscow, RUS, 105229, Russia

Location

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

Moscow, RUS, 111399, Russia

Location

NI Endrocrinological Research Centre of RAMS In patient replacing technologies department

Moscow, RUS, 115478, Russia

Location

NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky

Moscow, RUS, 129110, Russia

Location

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

Saint Petersburg, RUS, 193012, Russia

Location

Central Medical Sanitary Unit #122

Saint Petersburg, RUS, 194291, Russia

Location

St Petersburg NHI Municipal Multi-Speciality Hospital # 2

Saint Petersburg, RUS, 194354, Russia

Location

TUV Medico-Military Academy

Saint Petersburg, RUS, 198013, Russia

Location

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

Smolensk, RUS, 214018, Russia

Location

MHI Clinical Hospital for Emergency Care na NV Soloviev

Yaroslavl, RUS, 150003, Russia

Location

NHI Yaroslavl Regional Clinical Hospital

Yaroslavl, RUS, 150062, Russia

Location

NI Central Clinical Hospital of RAS

Moscow, 117 593, Russia

Location

Complejo Hospitalario Nuestra Senora de Valme

Seville, Andalusia, 41014, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Hospital Universitario de la Princessa

Madrid, 28006, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia

Sabadell, 08208, Spain

Location

Bukovinian State Medical University Dept of Clinical Immun

Chernivtsy, UKR, 58022, Ukraine

Location

Dniepropetrovsh State Medical Academy

Dniepropetrovsk, UKR, 49023, Ukraine

Location

Donetsk State Medical University

Donetsk, UKR, 83003, Ukraine

Location

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

Donetsk, UKR, 83099, Ukraine

Location

Railway Clinical Hospital on Donetsk Station

Donetsk, UKR, 83114, Ukraine

Location

Chair Family Med of National Med University

Kiev, UKR, 04050, Ukraine

Location

Institute of Endocrinology and Metabolism

Kiev, UKR, 04114, Ukraine

Location

Ukr Scientifically Practical Centre of Endocrine Surgery

Kiev, UKR, 2175, Ukraine

Location

Odessa State Medical University Dept of Gen Practice and Med Rehab

Odesa, UKR, 65009, Ukraine

Location

Odessa Reg. Clinical Hosp Outpatient Department

Odesa, UKR, 65025, Ukraine

Location

Odessa State Med Dept of Family Med and Gen Practice

Odesa, UKR, 65039, Ukraine

Location

Vinnitsa State Medical University

Vinnitsa, UKR, 21010, Ukraine

Location

Outpatient Clinic of Family Physician "Rusanovka"

Kiev, 02147, Ukraine

Location

Public Institution City Policlinic #20 Odessa

Odesa, 65114, Ukraine

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Secretagogues

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

Wks 12-24 was a non-randomized treatment period of the trial; outcomes were not analyzed for Wks 12-24. Safety results include entire trial; patients counted in multiple treatments for safety.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MannKind Corporation

aboss@mannkindcorp.com

201-983-5000

Study Officials

• For MannKind sponsored trials, the Overall Study Official is the Chief Scientific Officer

  Mannkind Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2006
• First Posted: June 1, 2006
• Study Start: December 1, 2004
• Primary Completion: March 1, 2008
• Last Updated: October 16, 2014
• Results First Posted: October 16, 2014

Record last verified: 2014-10

Locations

AR (5); CL (4); PL (8); UA (14); ME (6); CZ (8); CA (6); BR (8); RU (13); US (43); ES (5)