Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

Asthma Clinical Trial

Official title:

A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00332826
• Other study ID #: MKC-TI-105
• Status: Terminated
• Phase: Phase 3
• First received: June 1, 2006
• Last updated: May 3, 2012
• Start date: June 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2012
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines

• Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year

• Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)

• Subjects must exhibit <30% variability in PEF measurements during the 2 week run in period.

• Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period

• Body mass index (BMI) < 40kg/m2

• HbA1c >6.0% to <11.5%

Exclusion Criteria:

• Severe complications of diabetes in the opinion of the investigator

• Seizure disorder

• Significant cardiovascular dysfunction and/or history within 3 months of screening

• Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure >110 mm HG at screening despite pharmacologic therapy.

• Clinical nephrotic syndrome or renal dysfunction or disease

• Total daily insulin requirement of >1.4 U/kg body weight

• Clinical diagnosis of Step 4 asthma

• Use of >6 puffs/day of fast acting bronchodilator

• Currently using an insulin delivery pump

• Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening

• Two or more severe hypoglycemic episodes within the past 6 months.

• Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.

• Current use of systemic steroids

• Subjects who currently smoke tobacco or who have smoked within the past 6 months

• Urine cotinine test of > 100ng/ml

• Current drug or alcohol abuse

• Clinically significant abnormalities on screening laboratory evaluation

• Cancer within the past 5 years or any history of lung neoplasms

• History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.

• Active infection or history of severe infection with 30 days of screening.

• Anemia

• History of anaphylaxis and/or angioneurotic edema

• Diagnosis of chronic obstructive pulmonary disease (COPE)

• Previous exposure to any inhaled insulin product

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Technosphere Insulin

Locations

Country	Name	City	State
Argentina	DIM (Clinica Privada)	Buenos Aires
Argentina	Ins De Inv Cardiovascular La Plata	La Plata
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre
Brazil	Hospital Sao Lucas - PUCRS (Fritscher)	Porto Alegre
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda	Rio de Janeiro
Brazil	Clinica de Endocrinologia	Sao Paulo
Brazil	CPClin-Centro de Pesquisas Clinicas	Sao Paulo
Canada	Finchlea Medical Group	Brampton	Ontario
Canada	Courtice Health Centre	Courtice	Ontario
Canada	Parkwood Hospital	London	Ontario
Canada	The London Road Diagnostic Clinic and Medical Centre	Sarnia	Ontario
Canada	Albany Medical Center	Toronto	Ontario
Canada	Windsor Professional Research	Windsor	Ontario
Czech Republic	Surgery of Diabetology	Melnik	CZE
Czech Republic	I InternÃ- klinika	Ostrava
Czech Republic	InternÃ- a diabetologická Outpatient	Ostrava
Czech Republic	Interni oddeleni nemocnice Na Homolce	Praha 5	CZE
Czech Republic	Diabetologicka Outpatient Surgery of Diabetology	Slany	CZE
Mexico	Nuevo Sanatorio Durango	Delegacion Cuauhtemoc
Mexico	Hospital Angeles de las Lomas	Huixquilucan
Mexico	Hospital Angeles Mocel	Mexico City	DF
Mexico	Mexican Institute of Clinical Research	Mexico City	MX
Poland	Klinika Endocrinologii Diabetologii I	Bialystock	POL
Poland	NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny	Bialystok	POL
Poland	Dzial Badan Klinicznych Malopoiskie	Krakow	POL
Poland	III Oddzial Chorob Wewnetrznych Szpital	Krakow	POL
Poland	Oddzial Chorob Wewnetrznych Wojewodzki	Lodz	Zgierz
Poland	Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego	Lodz
Russian Federation	NHI Kemerovo Regional Clinical Hospital	Kemerovo	RUS
Russian Federation	Central Clinical Hospital of Russian Science Academy	Moscow
Russian Federation	City Clinical Hospital # 61	Moscow
Russian Federation	City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University	Moscow
Russian Federation	Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD	Moscow
Russian Federation	Moscow State Medico-Stomatological University City Hospital # 23	Moscow	RUS
Russian Federation	NI Principal Military Clinical Hospital n a academician N.N. Burdenko	Moscow	RUS
Russian Federation	Russian Scientific Center of Restoration Medicine & Balneology	Moscow
Russian Federation	Smolensk Medical Academy Smolensk Regional Clinical Hospital	Smolensk	RUS
Russian Federation	Central Medical Sanitary Unit #122	St Petersburg	RUS
Russian Federation	St Petersburg Medical Academy (Ilkovich)	St Petersburg
Russian Federation	City Hospital # 2 Endocrinology Department	St. Petersburg	RUS
Russian Federation	Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev	Yaroslavl	RUS
Spain	Hospital 2 de Maig	Barcelona
Ukraine	Donetsk State Medical University	Donetsk	UKR
Ukraine	Donetsk State Medical University	Donetsk	UKR
Ukraine	Railway Clinical Hospital on Donetsk Station	Donetsk	UKR
Ukraine	Chair Family Med of National Med University	Kiev	UKR
Ukraine	Institute of Endocrinology and Metabolism	Kiev	UKR
United Kingdom	Addenbrooke's Hospital Department of Medicine	Cambridge
United Kingdom	Clinical Research Centre The Royal London Hospital	London	GBR
United Kingdom	Northern General Hospital	Sheffield	GBR
United Kingdom	Birmingham Heartland Hospital	West Midlands	GBR
United States	Executive Health and Research Associates Inc	Atlanta	Georgia
United States	Pinaccle Trials Inc (SMO)	Atlanta	Georgia
United States	Franklin Square Hospital	Baltimore	Maryland
United States	Billings Clinic Research Division	Billings	Montana
United States	Associated Pharmaceutical Research Center Inc	Buena Park	California
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Cleveland Clinic Dept of Endocrinology	Cleveland	Ohio
United States	Carolinas Research	Concord	North Carolina
United States	Atlanta Pharmaceutical Research Center	Dunwoody	Georgia
United States	Healthcare Research	Florissant	Missouri
United States	Family Medical Center	Foothill Ranch	California
United States	Your Doctors Care	Hillsborough	New Jersey
United States	Golden Pine Clinical Research	Long Beach	California
United States	Health Care Partners Medical Group	Long Beach	California
United States	Keck USC School of Medicine	Los Angeles	California
United States	Eastside Comprehensive Medical Center	New York	New York
United States	Arizona Research Center	Phoenix	Arizona
United States	Northwest Medical Center	Phoenix	Arizona
United States	Southeastern Endocrine & Diabetes	Roswell	Georgia
United States	Diabetes & Glandular Disease Research Assoc PA	San Antonio	Texas
United States	MedEx Healthcare Research Inc(009)	St Louis	Missouri
United States	Premiere Pharmaceutical Research LLC	Tempe	Arizona
United States	Hopewell Valley Family Medicine PA	Trenton	New Jersey
United States	Canyon Internal Medicine	Tucson	Arizona
United States	McLennan County Medical Education and Research Foundation	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Czech Republic,  Mexico,  Poland,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period