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Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00539890
First received: October 3, 2007
Last updated: October 12, 2009
Last verified: October 2009
  Purpose

To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c >7.0% and <11.5%.


Condition Intervention Phase
Diabetes Type 2
Drug: Technosphere Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Open Label, Multi-Center Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • Mean change in HbA1c from baseline to treatment week 24 [ Time Frame: 24 weeks ]

Estimated Enrollment: 0
Study Start Date: November 2005
Study Completion Date: July 2006
  Eligibility

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

Inclusion Criteria:

  • At least 2 years since diagnosis of type 2 diabetes mellitus
  • Received subcutaneous (sc) insulin for at least 3 months
  • Body Mass Index <44 kg/m2
  • HbA1c>7.0% and <11.5%
  • Serum creatinine <2.0 mg/dL for males and <1.8 mg/dL for females
  • Baseline FVC and FEV1>70% and < 125% of predicted normal

Exclusion Criteria:

  • Significant hepatic disease (AST/ALT3 x ULN)
  • Diagnosis of Type 1 diabetes
  • Severe complications of diabetes
  • History of moderate to severe ketoacidosis within the past 3 months
  • Upper respiratory infection in the last 15 days or a lower respiratory infection in the past 30 days
  • Diagnosis of HIV
  • Positive serology for hepatitis B or C
  • COPD, emphysema, or asthma
  • Current smokers or smoking history within the past 6 months
  • Major psychiatric disorder precluding satisfactory completion of protocol
  • Clinically significant heart disease disease, stroke or heart attack within the past 6 months
  • Treatment with an investigational drug within 30 days
  • Previous treatment with Technosphere/Insulin
  • History of malignancy in the past 5 years except basal cell carcinoma
  • Anemia (hemoglobin <10.5 g/dL for females and <11.5 g/dL (for males)
  • Women who were pregnant of lactating
  • History of hypersensitivity to drugs resembling FDKP carrier products
  • Treatment with another inhaled insulin product during the duration of the study
  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: NCT00539890

Locations
Russian Federation
Ural State Medical Academy of Post-Graduate Education Municipal Clinical Hospital # 3
Chelyabinsk, RUS, Russian Federation, 454021
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, Russian Federation, 650061
SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
Moscow, RUS, Russian Federation, 127644
Moscow, RUS, Russian Federation, 125315
Clinical Research Institute of Physic-Chemical Medicine Hospital # 29
Moscow, RUS, Russian Federation, 111020
Moscow City Clinical Hospital # 20
Moscow, RUS, Russian Federation, 129327
Moscow Medical Academy
Moscow, RUS, Russian Federation, 123478
Moscow State Medical Stomatology University Municipal Hospital # 63 Endocrinology Diabetology
Moscow, RUS, Russian Federation, 129090
Moscow State Medico-Stomatological University City Hospital # 23
Moscow, RUS, Russian Federation, 109240
Municipal Clinical Hospital #13
Moscow, RUS, Russian Federation, 150062
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
Moscow, RUS, Russian Federation, 111399
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
Moscow, RUS, Russian Federation, 105229
Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
Moscow, RUS, Russian Federation, 117036
Russian State Medical University
Moscow, RUS, Russian Federation, 109263
Russian State Medical University Central Clinical Hospital Russian Science Academy
Moscow, RUS, Russian Federation, 117593
Russian State Medical University City Hospital # 4
Moscow, RUS, Russian Federation, 113093
Sechenov Moscow Medical Academy
Moscow, RUS, Russian Federation, 119881
Moscow Hospital of Glavmosstroy State Unitary Enterprise Medical Centre Medical Sanitary Unit #47
Moscow, RUS, Russian Federation, 117192
Nizhni Novgorod regional hospital na Semashko
N Novgorod, RUS, Russian Federation, 603126
Center Diabetes LLC
Samara, RUS, Russian Federation, 443067
Saratov Medical University Faculty Therapy Chair Clinical Hospital # 3
Saratov, RUS, Russian Federation, 410054
Saratov City Outpatient Clinic # 20
Saratov, RUS, Russian Federation, 410038
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
Smolensk, RUS, Russian Federation, 214018
TUV Medico-Military Academy
St Petersburg, RUS, Russian Federation, 198013
Central Medical Sanitary Unit #122
St Petersburg, RUS, Russian Federation, 194291
City Outpatient Clinic # 34
St Petersburg, RUS, Russian Federation, 197198
Pavlov State Medical Univ of St Petersburg
St Petersburg, RUS, Russian Federation, 197022
SPb Diabetological Center
St Petersburg, RUS, Russian Federation, 194354
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
St Petersburg, RUS, Russian Federation, 193012
St Petersburg Medical Academy St Elizabeth Hospital
St Petersburg, RUS, Russian Federation, 195257
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
St. Petersburg, RUS, Russian Federation, 194354
MHI Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, Russian Federation, 150003
Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, Russian Federation, 150062
Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Director: Robert Baughman, PhD Mannkind Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00539890     History of Changes
Other Study ID Numbers: MKC-TI-014
Study First Received: October 3, 2007
Last Updated: October 12, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014