Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

Diabetes, Type I Clinical Trial

Official title:

A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308308
• Other study ID #: MKC-TI-009
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2006
• Last updated: October 9, 2014
• Start date: February 2006
• Est. completion date: August 2008

Study information

• Verified date: October 2014
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of type 1 diabetes for at least 1 year

• Nonsmokers for prior 6 months

• BMI less than or equal to 35kg/m2

• HbA1c > or = 7% and < or = 11%

• Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects

• FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted

• Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day

• Urine cotinine < or = 100 ng/mL

Exclusion Criteria:

• History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings

• Evidence of severe complications of diabetes

• Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Type I

Intervention

Drug:
• Technosphere Insulin
Inhalation, 15U/30U
• Active comparator
sc injectable insulin

Locations

Country	Name	City	State
Argentina	Hospital Interzonal de Agudos Pedro Fiorito	Avellaneda	Buenos Aires
Argentina	Centro Endocrinologic Tiempo	Buenos Aires
Argentina	Centro Medico Dra De Salvo	Buenos Aires
Argentina	CIMeL	Buenos Aires
Argentina	Cons Asoc de Endocrinologia	Buenos Aires
Argentina	Hospital Durand /Buenos Aires	Buenos Aires
Argentina	Hospital Gral De Agudos Dr. Teodoro Alvarez	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Brazil	Universidade Estabual de Maringa	Maringa Parana
Brazil	Nucleo de Medicina Integrada	Mogi das Cruzes
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Hospital Sao Lucas da PUCRS	Porto Alegre	Rio Grande do Sul
Brazil	Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda	Rio de Janeiro
Brazil	Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione	Rio de Janeiro
Brazil	Hospital Guilherme Alvaro	Santos
Brazil	Blumenau Servicos Medicos S/C Ltda	Sao Paulo
Brazil	Centro de Diabetes/UNIFESP-EPM	Sao Paulo
Brazil	CPClin-Centro de Pesquisas Clinicas	Sao Paulo
Brazil	Instituto de Pesquisa Clinica e Medicina Avancada	Sao Paulo
Canada	Lifestyle Metabolism Center	Oakville	Ontario
Canada	Lifestyle Metabolism Center	Thornhill	Ontario
Canada	Lifestyle Metabolism Center	Toronto	Ontario
Canada	Windsor Professional Research	Windsor	Ontario
Chile	Hospital Clinico Pontificia Universidad (009)Catolica de Chile	Santiago
Chile	Hospital del Salvador	Santiago	Region Metropolitana
Chile	Hospital Padre Alberto Hurtado	Santiago
Chile	Hospital San Borja ArriaranUniversidad de Chile	Santiago
Chile	Hospital San Jose	Santiago
Chile	Instituto de Informacion de Tramiento y Educacion en Salud	Santiago
Mexico	Hospital Santa Engracia-CIMA	Garza Garcia
Mexico	Centro de Estudios en Diabetes	Mexico City
Mexico	Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio	Mexico City
Mexico	Instituto Mexicano de Investigacion	Mexico City	Durango
Mexico	Hospital OCA-MIRC (009)	Monterrey
Poland	NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny	Bialystok	POL
Poland	Oddzial Chorob Wewnetrznych (009 Endokrynologii I Diabetologii Szpitala Wojewodzkiego	Bialystok
Poland	Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego	Krakow	POL
Poland	Instytut Centrum Zdrowia (009) Matki Polki	Lodz	POL
Poland	Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego	Lodz
Poland	Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii	Pruszkow	POL
Poland	NZOZ Diabetologiczna Poradnia Specjalistyczna	Warszawa
Russian Federation	NHI Kemerovo Regional Clinical Hospital	Kemerovo	RUS
Russian Federation	City Clinical Hospital # 61	Moscow
Russian Federation	Moscow City Clinical Hospital # 13	Moscow	RUS
Russian Federation	NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70	Moscow	RUS
Russian Federation	NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense	Moscow	RUS
Russian Federation	RAAMS Endocrinology and Diabetology Department	Moscow	RUS
Russian Federation	Russian Scientific Center of Restoration Medicine & Balneology	Moscow
Russian Federation	SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology	Moscow	RUS
Russian Federation	SI Internal Affairs of Moscow- Clinical Hospital	Moscow	RUS
Russian Federation	SIH of Moscow City Clinical Hopsital #81Endocrinology and Diabetology	Moscow	RUS
Russian Federation	Central Medical Sanitary Unit #122	St Petersburg	RUS
Russian Federation	Pavlov State Medical Univ of St Petersburg	St Petersburg	RUS
Russian Federation	St Petersburg NHI City Polytclinic #77 City Diabetological Center #4	St Petersburg	RUS
Russian Federation	St Petersburg NHI Municipal Multi-Speciality Hospital # 2	St. Petersburg	RUS
Russian Federation	MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant	Yaroslavl	RUS
Russian Federation	MHI Clinical Hospital for Emergency Care na NV Soloviev	Yaroslavl	RUS
Russian Federation	NHI Yaroslavl Regional Clinical Hospital	Yaroslavl	RUS
Spain	Hospital del Mar	Barcelona
Spain	Hospital Ramon y Cajal	Madrid
Spain	Complejo Hospitalario Nuestra Senora de Valme	Sevilla	Andalucia
Spain	Complejo Hospitalario Virgen del Rocio	Sevilla
Spain	Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion	Sevilla
United Kingdom	Birchwood Surgery	Letchworth	Herts
United Kingdom	Guy's & St Thomas Hospital	London
United Kingdom	Sandwell General Hospital	Lyndon	West Bromwich
United Kingdom	Yaxley Group Practice	Peterborough
United Kingdom	Lister Hospital	Stevenage	Herts
United States	University of New Mexico HCS	Albuquerque	New Mexico
United States	Israel Hartman MD	Arlington	Texas
United States	Laureate Clinical Research Group	Atlanta	Georgia
United States	AM Diabetes and Endocrinology Center	Bartlett	Tennessee
United States	Pennsylvania Research Institute	Bensalem	Pennsylvania
United States	Billings Clinic Research Division	Billings	Montana
United States	Radiant Research (Phoenix)	Chandler	Arizona
United States	John H Stoger Jr Hospital of Cook County	Chicago	Illinois
United States	International Clinical Research Network	Chula Vista	California
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor Endocrine Center	Dallas	Texas
United States	Dallas Diabetes & Endocrine Center	Dallas	Texas
United States	Radiant Research Dallas-North	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Providence Health Partners - Center of Clinical Research	Dayton	Ohio
United States	Wayne State University	Detroit	Michigan
United States	Atlanta Pharmaceutical Research Center	Dunwoody	Georgia
United States	Radiant Research Inc (Minneapolis)	Edina	Minnesota
United States	Larry D Stonesifer MD Inc PS	Federal Way	Washington
United States	Hurley Medical Center	Flint	Michigan
United States	Healthcare Research	Florissant	Missouri
United States	Family Medical Center	Foothill Ranch	California
United States	Spuhler Medical Associates	Friendswood	Texas
United States	Endocrine Research - Physician's East PA	Greenville	North Carolina
United States	Diabetes/Lipid Management and Research Center	Huntington Beach	California
United States	South Bay Clinical Research	Inglewood	California
United States	North Atlanta Endocrinology & Diabetes PC	Lawrenceville	Georgia
United States	Michigan Institute of Medicine	Livonia	Michigan
United States	The Endocrine Clinic	Memphis	Tennessee
United States	Medical Research of Louisiana	Metairie	Louisiana
United States	International Research Associates LLC	Miami	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	Center for Urologic Clinical Trials University of Minnesota	Minneapolis	Minnesota
United States	International Diabetes Center	Minneapolis	Minnesota
United States	Coastal Clinical Research Inc	Mobile	Alabama
United States	North Shore Diabetes and Endocrine Associates	New Hyde Park	New York
United States	Oschner Clinic Foundation	New Orleans	Louisiana
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	Covance CRU Inc.	Portland	Oregon
United States	Legacy Clinical Research	Portland	Oregon
United States	Portland Diabetes & Endocrinology Center	Portland	Oregon
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Radiant Research Salt Lake City	Salt Lake City	Utah
United States	Salt Lake Research	Salt Lake City	Utah
United States	Diabetes & Glandular Disease Research Assoc PA	San Antonio	Texas
United States	Quality Assurance Research Center (900)	San Antonio	Texas
United States	SAM Clinical Research Center	San Antonio	Texas
United States	Radiant Research	San Diego	California
United States	Coastal Biomedical Research Inc	Santa Monica	California
United States	Edward Bali MD PA	Seguin	Texas
United States	Clintell Inc	Skokie	Illinois
United States	KMED Research	St Clair Shores	Michigan
United States	MedEx Healthcare Research Inc(009)	St Louis	Missouri
United States	Amin Radparvar's Private Practice	St Peters	Missouri
United States	University of Physicians Group Endocrine Division	Staten Island	New York
United States	Cedar Research	Tacoma	Washington
United States	Liberty Research Center	Tacoma	Washington
United States	James A Dicke MDPA	Towson	Maryland
United States	Diabetes Research Center	Tustin	California
United States	Sentara Medical Group	Virginia Beach	Virginia
United States	Southeastern Research Associates Inc	Williamston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Chile,  Mexico,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the Mean Change From Baseline to Week 52 in HbA1c		Baseline to Week 52	No
Secondary	Change From Baseline in Weight to Week 52	Change from baseline in weight at Week 52	Baseline to Week 52	No
Secondary	Change From Baseline in Fasting Plasma Glucose to Week 52	Change from baseline in fasting plasma glucose at Week 52	Baseline to Week 52	No
Secondary	Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%	Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%	Baseline to Week 52	No
Secondary	Incidence of Total Hypoglycemia	Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.	Baseline to Week 52	Yes
Secondary	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.	Baseline to Week 52	Yes
Secondary	Total Hypoglycemia Event Rate	Number of Hypoglycemic Events/Total Subject Exposure Time (in months)	Baseline to Week 52	Yes
Secondary	Severe Hypoglycemia Event Rate	Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)	Baseline to Week 52	Yes