A 2-Month Safety Follow-Up Trial

Type 2 Diabetes Clinical Trial

Official title:

A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741429
• Other study ID #: MKC-TI-126
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2008
• Last updated: December 1, 2014
• Start date: May 2007
• Est. completion date: September 2008

Study information

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

Clinical Trial Summary

The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.

Description:

This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse event data included are for the combined Safety population irrespective of previous treatments in the parent trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 649
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030)

• Urine cotinine test of less than or equal to 100 ng/mL

• Written informed consent

Exclusion Criteria:

• Subjects who started smoking during the 4 week follow-up phase of the parent trial

• Subjects who began a new inhaled insulin regimen with an investigational drug during the 4 week follow-up phase of the parent trial and/or are participation in another clinical trial

• Female subjects who are pregnant, lactating or planning on becoming pregnant

• Subjects with a positive urine drug screening at Visit 1

• Female subjects of child-bearing potential not practicing adequate birth control

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Drug:
• Technosphere Insulin Inhalation Powder
Subjects previously treated with Technosphere Insulin Inhalation Powder
• Comparator
Subjects previously treated with other anti-diabetic medications

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	CPClin-Centro de Pesquisas Clinicas	Sao Paulo
Canada	Aggarwal and Associates Ltd	Brampton	Ontario
Canada	Parkwood Hospital	London	Ontario
Canada	Quest Clinical Trials	Markham	Ontario
Canada	Lifestyle Metabolism Center	Oakville	Ontario
Canada	Sarnia Institute of Clinical Research	Sarnia	Ontario
Canada	The London Road Diagnostic Clinic and Medical Centre	Sarnia	Ontario
Canada	Lifestyle Metabolism Center	Thornhill	Ontario
Canada	Lifestyle Metabolism Center	Toronto	Ontario
Canada	Manna Research	Toronto	Ontario
Canada	Trial Management Group Inc (Henein	Toronto	Ontario
Russian Federation	Kemerovo State Medical Academy of Ministry of Health	Kemerovo	RUS
Russian Federation	NHI Kemerovo Regional Clinical Hospital	Kemerovo	RUS
Russian Federation	City Clinical Hospital # 61	Moscow	RUS
Russian Federation	Moscow City Clinical Hospital # 13	Moscow	RUS
Russian Federation	Moscow State Medical-Stomatological University City Clinical Hospital # 23	Moscow	RUS
Russian Federation	NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70	Moscow	RUS
Russian Federation	NI Central Clinical Hospital of RAS	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	RUS
Russian Federation	Russian State Medical University Central Clinical Hospital Russian Science Academy	Moscow	RUS
Russian Federation	Russian State Medical University City Hospital # 4	Moscow	RUS
Russian Federation	SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology	Moscow	RUS
Russian Federation	SHI of Moscow City Clinical Hospital #13	Moscow	RUS
Russian Federation	SI Internal Affairs of Moscow- Clinical Hospital	Moscow	RUS
Russian Federation	SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology	Moscow	RUS
Russian Federation	Ryazan State Medical University na academician IP Pavlov	Ryazan	RUS
Russian Federation	NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital	Smolensk	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 Medical Academy St Elizabeth Hospital	St Petersburg	RUS
Russian Federation	St Petersburg NHI City Polytclinic #77 City Diabetological Center #4	St Petersburg	RUS
Russian Federation	TUV Medico-Military Academy	St Petersburg	RUS
Russian Federation	St Petersburg NHI Municipal Multi-Speciality Hospital # 2	St. Petersburg	RUS
Russian Federation	Clinical Pharm Dept of Yaroslavl Clin Hospital	Yaroslavl	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
Russian Federation	Yaroslavl Regional Clinical Hospital	Yaroslavl	RUS
United States	Lovelace Scientific Resources (Albuquerque)	Albuquerque	New Mexico
United States	New Mexico Clinical Research & Osteoporosis Center	Albuquerque	New Mexico
United States	Southwest Endocrinology Associates	Albuquerque	New Mexico
United States	University of New Mexico HCS	Albuquerque	New Mexico
United States	Israel Hartman MD	Arlington	Texas
United States	Executive Health and Research Associates Inc	Atlanta	Georgia
United States	Laureate Clinical Research Group	Atlanta	Georgia
United States	Franklin Square Hospital	Baltimore	Maryland
United States	Health Trends Research LLC	Baltimore	Maryland
United States	MODEL Clinical Research	Baltimore	Maryland
United States	AM Diabetes and Endocrinology Center	Bartlett	Tennessee
United States	Deaconess Billings Clinic Research Center	Billings	Montana
United States	Montana Health Research Institute	Billings	Montana
United States	Parkway Medical Center	Birmingham	Alabama
United States	Pharmaceutical Research Organization	Bountiful	Utah
United States	Private Practice	Burlingame	California
United States	Radiant Research (Phoenix)	Chandler	Arizona
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	Sensenbrenner Primary Care	Charlotte	North Carolina
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	John H Stoger Jr Hospital of Cook County	Chicago	Illinois
United States	International Clinical Research Network	Chula Vista	California
United States	Rapid Medical Research Inc	Cleveland	Ohio
United States	Texas Familicare Clinical Research	Colleyville	Texas
United States	Collierville Medical Specialists	Collierville	Tennessee
United States	Rockdale Medical Research Associates	Conyers	Georgia
United States	Baylor Endocrine Center	Dallas	Texas
United States	Dallas Diabetes & Endocrine Center	Dallas	Texas
United States	Galenos Research	Dallas	Texas
United States	North Texas 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	Private Practice	Decatur	Georgia
United States	Creekside Endocrine Associates	Denver	Colorado
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	Diabetes Care & Information Center of New York	Flushing	New York
United States	Family Medical Center	Foothill Ranch	California
United States	Saad Hijazi MD Inc	Fresno	California
United States	Saint Agnes Medical Center	Fresno	California
United States	Valley Research	Fresno	California
United States	Spuhler Medical Associates	Friendswood	Texas
United States	Digestive & Liver Disease Specialist A Medical Group Inc	Garden Grove	California
United States	Physician's East PA	Greenville	North Carolina
United States	Upstate Pharmaceutical Research	Greenville	South Carolina
United States	Your Doctors Care	Hillsborough	New Jersey
United States	Center for Diabetes & Endocrine Care	Hollywood	Florida
United States	Diabetes/Lipid Management and Research Center	Huntington Beach	California
United States	Wells Institute for Health Awareness	Kettering	Ohio
United States	North Atlanta Endocrinology & Diabetes PC	Lawrenceville	Georgia
United States	Interlink Research Institute	Los Alamitos	California
United States	Magna Center for Family Medicine	Magna	Utah
United States	Memphis Internal Medicine PLLC	Memphis	Tennessee
United States	Your Diabetes Endocrine Nutrition Group	Mentor	Ohio
United States	International Research Associates LLC	Miami	Florida
United States	University of Miami Diabetes Research Institute	Miami	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	Center for Urologic Clinical Trials University of Minnesota	Minneapolis	Minnesota
United States	Coastal Clinical Research Inc	Mobile	Alabama
United States	Bucks County Clinical Research	Morrisville	Pennsylvania
United States	North Shore Diabetes and Endocrine Associates	New Hyde Park	New York
United States	M.E.R.I.	New York	New York
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	Southern California Endocrine Center	Pasadena	California
United States	Northwest Medical Center	Phoenix	Arizona
United States	Southwest Health Ltd Research Division	Phoenix	Arizona
United States	SMO: Pharmaceuticals C-Trials North Texas Medical Research	Plano	Texas
United States	Covance CRU Inc.	Portland	Oregon
United States	Legacy Clinical Research	Portland	Oregon
United States	Portland Diabetes & Endocrinology Center	Portland	Oregon
United States	Rainier Clinical Research Center Inc	Renton	Washington
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	Clinical Trials of Texas Inc	San Antonio	Texas
United States	Covenant Clinic Research	San Antonio	Texas
United States	Diabetes & Glandular Disease Research Assoc PA	San Antonio	Texas
United States	Quality Assurance Research Center Inc	San Antonio	Texas
United States	SAM Clinical Research Center	San Antonio	Texas
United States	Dorothy L & James E Frank Diabetes Research Institute	San Mateo	California
United States	Sansum Medical Research Institute	Santa Barbara	California
United States	Coastal Biomedical Research Inc	Santa Monica	California
United States	Encompass Clinical Research	Spring Valley	California
United States	KMED Research	St Clair Shores	Michigan
United States	Clayton Medical Research	St Louis	Missouri
United States	MedEx Healthcare Research Inc(009)	St Louis	Missouri
United States	Amin Radparvar's Private Practice	St Peters	Missouri
United States	Mercy Health Research	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Univeristy of Physicians Group Endocrine Division	Staten Island	New York
United States	Cedar Research	Tacoma	Washington
United States	Liberty Research Center	Tacoma	Washington
United States	Southeastern Research Associates Inc	Taylors	South Carolina
United States	Scott & White Hospital and Clinic	Temple	Texas
United States	James A Dicke MDPA	Towson	Maryland
United States	Hopewell Valley Medical Group	Trenton	New Jersey
United States	Canyon Clinical Research	Tucson	Arizona
United States	Arizona Research Associates	Tuscon	Arizona
United States	Diabetes Research Center	Tustin	California
United States	Sentara Medical Group	Virginia Beach	Virginia
United States	Umdnj-Som	Voorhees	New Jersey
United States	Chase Medical Research LLC	Waterbury	Connecticut
United States	Wenatchee Valley Medical Center Clinical Research Department	Wenatchee	Washington
United States	Granger Medical Clinic	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126		9 to 27 months	Yes
Secondary	Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126		9 to 27 months	Yes
Secondary	Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126		9 to 27 months	Yes
Secondary	Change in Hemoglobin Corrected DLco (mL/min/mm Hg) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126		9 to 27 months	Yes
Secondary	Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126		3 Months	Yes
Secondary	Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126		3 Months	Yes
Secondary	Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126		3 Months	Yes
Secondary	Change in Hemoglobin Corrected DLco (mL/min/mmHg) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126		3 Months	Yes