Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

This study is ongoing, but not recruiting participants.

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00309244

Purpose

The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

Condition	Intervention	Phase
Diabetes Type 2	Drug: Technosphere/Insulin Drug: Comparator Treatment	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Ty0pe 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere /Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

To compare the mean change from baseline to Week 52 of percentage of glycosylated hemoglobin (HbA1c) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	676
Study Start Date:	February 2006
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Technosphere Insulin	Drug: Technosphere/Insulin Inhalation, 15U/30U
2: Active Comparator Comparator Treatment	Drug: Comparator Treatment BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes currently receiving pre-/self mixed insulin therapy 2 to 3 times daily where fast acting component is either regular or rapid acting insulin non-smoking Body mass index 40 kg/m2 HbA1c > 7.0% < 11.0% FEV1 > or = 70% predicted (NHANES III); DLco > or = 70% predicted (Miller) Total Lung Capacity > or = 80% predicted (ITS)

Exclusion Criteria:

Concomitant sulphonylureas, meglitinide, or other non-sulfonylurea secretagogues, pramlintide acetate (Symlin®), and/or any incretin (eg, Byetta®) within the preceding 6 weeks History of viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes history of chronic obstructive pulmonary disease, asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease Evidence of severe complications of diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309244

Show 152 Study Locations

Sponsors and Collaborators

Mannkind Corporation

More Information

Responsible Party:	MannKind Corporation ( Anders Boss, MD, MFPM, Chief Medical Officer )
Study ID Numbers:	MKC-TI-102
Study First Received:	March 27, 2006
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00309244
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
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009