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.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00309244
First received: March 27, 2006
Last updated: October 1, 2009
Last verified: October 2009
  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 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

  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
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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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014