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 has been completed.
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
First received: March 27, 2006
Last updated: October 1, 2009
Last verified: October 2009

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

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
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Technosphere Insulin
Drug: Technosphere/Insulin
Inhalation, 15U/30U
Active Comparator: 2
Comparator Treatment
Drug: Comparator Treatment
BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 151 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided by Mannkind Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anders Boss, MD, MFPM, Chief Medical Officer, MannKind Corporation
ClinicalTrials.gov Identifier: NCT00309244     History of Changes
Other Study ID Numbers: MKC-TI-102
Study First Received: March 27, 2006
Last Updated: October 1, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014