An Open-Label, Multi-Center, International, Three-Year, Safety and Tolerability 'Follow on' Trial

This study is ongoing, but not recruiting participants.

First Received: September 16, 2008 Last Updated: September 17, 2008 History of Changes

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00754624

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Technosphere®/ Insulin and MedTone™ Inhaler	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Three-Year, Safety and Tolerability, Open-Label, 'Follow on' Trial Evaluating Technosphere /Insulin in Subjects With Type 2 Diabetes Mellitus.

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

To evaluate the safety and tolerability of inhaled Technosphere®/Insulin in subjects with type 2 diabetes who have previously completed enrollment in one of the following MannKind Corporation clinical trials; PDC-INS-0008 & MKC-TI-005 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment:	228
Study Start Date:	May 2004
Estimated Study Completion Date:	October 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Technosphere®/ Insulin 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

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754624

Sponsors and Collaborators

Mannkind Corporation

Investigators

Study Director:

Anders Boss, MD

Mannkind Corporation

More Information

No publications provided

Responsible Party:	MannKind Corporation ( Anders Boss, Chief Medical Officer & Senior Vice President )
Study ID Numbers:	MKC-TI-010
Study First Received:	September 16, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00754624 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009