An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Four-year, Safety and Tolerability, Open-Label, "Follow on" Trial Evaluating Technosphere® Insulin in Subjects With Type 2 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754624
• Other study ID #: MKC-TI-010
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2008
• Last updated: October 9, 2014
• Start date: May 2004
• Est. completion date: October 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

Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005

Description:

This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, & 2 for 48 mo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: October 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Previous completion of PDC-INS-0008 or MKC-TI-005

• Subjects must be able to attend all scheduled visits and, in the opinion of the Investigator, be able to complete this safety trial

• Subjects must be able to understand English or have access to validated primary language trial documents

• Written informed consent

Exclusion Criteria:

• Drug or alcohol dependency

• Smokers (subjects are expected to remain non-smokers throughout their participation in this trial)

• Known hypersensitivity to the trial drug or to drugs of similar chemical structures

• Anemia (hemoglobin level < 11 g/dL for females or < 12 g/dL for males)

• Evidence of moderate or greater ketones in urine

• Women of childbearing potential practicing inadequate birth control. (Adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, Depo-Provera, contraceptive patches or surgical sterilization)

• Women who are pregnant

• Clinically significant adverse events that remain unresolved from the previous trial and/or clinically significant abnormal laboratory values which are determined by the Investigator or the MKC Medical Monitor to be unsafe or confounding to continued participation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U

Locations

Country	Name	City	State
Bulgaria	MBAL "Pleven"	Pleven	BGR
Bulgaria	Central Clinical Base	Sofia	BGR
Bulgaria	II-nd MBAL	Sofia
Bulgaria	MBAL Alexandrovska Hospital	Sofia	BGR
Bulgaria	Military Medical Academy	Sofia	BGR
Bulgaria	Military Medical Academy	Sofia
Bulgaria	SBALENG-Sofia Institute of Endocrinology	Sofia	BGR
Bulgaria	MBAL "Sweta Marina" - Varna	Varna	BGR
Czech Republic	Hospital of "Milosrdnych brain"	Brno	CZE
Czech Republic	Military Hospital in Brno	Brno	CZE
Czech Republic	Surgery of Diabetology (Brno)	Brno
Czech Republic	University Hospital in Brno	Brno-Bohunice	CZE
Czech Republic	Surgery of Diabetology	Melnik	CZE
Czech Republic	Surgery of Diabetology Petrovice	Prague	CZE
Czech Republic	Surgery of Diabetology Stodulky	Prague	CZE
Czech Republic	University Hospital of 3rd Faculty	Prague 10	CZE
Czech Republic	Diabetologicka oridnace	Prague 2	CZE
Czech Republic	General Hospital in Prague and 1st Faculty of Medicine of	Prague 2	CZE
Czech Republic	Institute for Clinical and Exp Medicine	Prague 4	CZE
Czech Republic	University Hospital Na Bulovce	Prague 8	CZE
Czech Republic	Surgery of Diabetology Slany	Slany	CZE
Czech Republic	Surgery of Diabetology Zastavka	Zastavka, Brno	CZE
Germany	ikfe Berlin	Berlin	DEU
United States	Dallas Diabetes & Endocrine Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Diabetes Care & Information Center of New York	Flushing	New York
United States	Endocrine Research - Physician's East PA	Greenville	North Carolina
United States	Your Diabetes Endocrine Nutrition Group	Mentor	Ohio
United States	University of Miami School of Medicine	Miami	Florida
United States	Alliance Medical Group of Greater Waterbury	Middlebury	Connecticut
United States	International Diabetes Center	Minneapolis	Minnesota
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Oschner Clinic Foundation	New Orleans	Louisiana
United States	Diabetes Team Associated	New York	New York
United States	Soundview Research Associates	Norwalk	Connecticut
United States	Diabetes & Glandular Disease Research Assoc PA	San Antonio	Texas
United States	Texas Diabetes Institute	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	Diabetes Care Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual Rate of Change in FEV1 From Baseline to End of Study		Baseline to 48 months	Yes
Secondary	Annual Rate of Change in FVC From Baseline to End of Study		Baseline to 48 months	Yes
Secondary	Annual Rate of Change in DLCo From Baseline to End of Study		Baseline to 48 months	Yes
Secondary	Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)	Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months)	Baseline to last measurement on study drug (maximum of 48 months	No
Secondary	Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)	Change from Baseline to last study measurement on treatment (maximum of 48 months)	Baseline to last study measurement on treatment (maximum of 48 months)	No
Secondary	Change in Weight in kg From Baseline to End of Study	Baseline to last measurement on study drug (maximum of 48 months)	Baseline to last measurement on study drug (maximum of 48 months)	No
Secondary	High Resolution Computerized Tomography Scans of the Chest		End of study	Yes