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

NCT00754624 | Completed Phase 2 Results

• 1 other identifier: MKC-TI-010
• Study Type: interventional
• Target: 229
• Locations: 4 countries
• Sites: 40

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Annual Rate of Change in FEV1 From Baseline to End of Study

  Baseline to 48 months

Secondary Outcomes (6)

• Annual Rate of Change in FVC From Baseline to End of Study

  Baseline to 48 months

• Annual Rate of Change in DLCo From Baseline to End of Study

  Baseline to 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

• Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)

  Baseline to last study measurement on treatment (maximum of 48 months)

• Change in Weight in kg From Baseline to End of Study

  Baseline to last measurement on study drug (maximum of 48 months)

Study Arms (1)

TI Inhalation Powder

EXPERIMENTAL

Technosphere® Insulin Inhalation Powder

Drug: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler

Interventions

Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler DRUG

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

TI Inhalation Powder

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (40)

Dorothy L & James E Frank Diabetes Research Institute

San Mateo, California, 94401, United States

Location

Sansum Medical Research Institute

Santa Barbara, California, 93105, United States

Location

Alliance Medical Group of Greater Waterbury

Middlebury, Connecticut, 06762, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Soundview Research Associates

Norwalk, Connecticut, 06851, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Oschner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Diabetes Care & Information Center of New York

Flushing, New York, 11365, United States

Location

Diabetes Team Associated

New York, New York, 10016, United States

Location

Endocrine Research - Physician's East PA

Greenville, North Carolina, 27834, United States

Location

Your Diabetes Endocrine Nutrition Group

Mentor, Ohio, 44060, United States

Location

Dallas Diabetes & Endocrine Center

Dallas, Texas, 75230, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Texas Diabetes Institute

San Antonio, Texas, 78207, United States

Location

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, 78229, United States

Location

Diabetes Care Center

Seattle, Washington, 98105, United States

Location

MBAL "Pleven"

Pleven, BGR, 5800, Bulgaria

Location

SBALENG-Sofia Institute of Endocrinology

Sofia, BGR, 1303, Bulgaria

Location

MBAL Alexandrovska Hospital

Sofia, BGR, 1431, Bulgaria

Location

Military Medical Academy

Sofia, BGR, 1431, Bulgaria

Location

Central Clinical Base

Sofia, BGR, 1606, Bulgaria

Location

MBAL "Sweta Marina" - Varna

Varna, BGR, 5000, Bulgaria

Location

II-nd MBAL

Sofia, Sofia, 1202, Bulgaria

Location

Military Medical Academy

Sofia, 1431, Bulgaria

Location

Military Hospital in Brno

Brno, CZE, 636 00, Czechia

Location

Hospital of "Milosrdnych brain"

Brno, CZE, 639 00, Czechia

Location

University Hospital in Brno

Brno-Bohunice, CZE, 625 00, Czechia

Location

Surgery of Diabetology

Mělník, CZE, 276 01, Czechia

Location

University Hospital of 3rd Faculty

Prague, CZE, 100 34, Czechia

Location

Surgery of Diabetology Petrovice

Prague, CZE, 109 00, Czechia

Location

Diabetologicka oridnace

Prague, CZE, 120 00, Czechia

Location

General Hospital in Prague and 1st Faculty of Medicine of

Prague, CZE, 120 00, Czechia

Location

Institute for Clinical and Exp Medicine

Prague, CZE, 140 21, Czechia

Location

Surgery of Diabetology Stodulky

Prague, CZE, 155 00, Czechia

Location

University Hospital Na Bulovce

Prague, CZE, 180 81, Czechia

Location

Surgery of Diabetology Slany

Slaný, CZE, 274 01, Czechia

Location

Surgery of Diabetology Zastavka

Zastavka, Brno, CZE, 664 84, Czechia

Location

Surgery of Diabetology (Brno)

Brno, 612 00, Czechia

Location

ikfe Berlin

Berlin, DEU, D 10115, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MannKind Corporation

aboss@mannkindcorp.com

201-983-5000

Study Officials

• Anders Boss, MD

  Mannkind Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: May 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 16, 2014
• Results First Posted: October 16, 2014

Record last verified: 2014-10

Locations

US (17); DE (1); BU (8); CZ (14)