Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
N/A
1 country
33
Brief Summary
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2005
Shorter than P25 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 3, 2007
CompletedFirst Posted
Study publicly available on registry
October 5, 2007
CompletedOctober 14, 2009
October 1, 2009
October 3, 2007
October 12, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change in HbA1c from baseline to treatment week 24
24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Ural State Medical Academy of Post-Graduate Education Municipal Clinical Hospital # 3
Chelyabinsk, RUS, 454021, Russia
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, 650061, Russia
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
Moscow, RUS, 105229, Russia
Moscow State Medico-Stomatological University City Hospital # 23
Moscow, RUS, 109240, Russia
Russian State Medical University
Moscow, RUS, 109263, Russia
Clinical Research Institute of Physic-Chemical Medicine Hospital # 29
Moscow, RUS, 111020, Russia
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
Moscow, RUS, 111399, Russia
Russian State Medical University City Hospital # 4
Moscow, RUS, 113093, Russia
Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
Moscow, RUS, 117036, Russia
Moscow Hospital of Glavmosstroy State Unitary Enterprise Medical Centre Medical Sanitary Unit #47
Moscow, RUS, 117192, Russia
Russian State Medical University Central Clinical Hospital Russian Science Academy
Moscow, RUS, 117593, Russia
Sechenov Moscow Medical Academy
Moscow, RUS, 119881, Russia
Moscow Medical Academy
Moscow, RUS, 123478, Russia
Unknown Facility
Moscow, RUS, 125315, Russia
SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
Moscow, RUS, 127644, Russia
Moscow State Medical Stomatology University Municipal Hospital # 63 Endocrinology Diabetology
Moscow, RUS, 129090, Russia
Moscow City Clinical Hospital # 20
Moscow, RUS, 129327, Russia
Municipal Clinical Hospital #13
Moscow, RUS, 150062, Russia
Nizhni Novgorod regional hospital na Semashko
Nizhny Novgorod, RUS, 603126, Russia
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
Saint Petersburg, RUS, 193012, Russia
Central Medical Sanitary Unit #122
Saint Petersburg, RUS, 194291, Russia
SPb Diabetological Center
Saint Petersburg, RUS, 194354, Russia
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
Saint Petersburg, RUS, 194354, Russia
St Petersburg Medical Academy St Elizabeth Hospital
Saint Petersburg, RUS, 195257, Russia
Pavlov State Medical Univ of St Petersburg
Saint Petersburg, RUS, 197022, Russia
City Outpatient Clinic # 34
Saint Petersburg, RUS, 197198, Russia
TUV Medico-Military Academy
Saint Petersburg, RUS, 198013, Russia
Center Diabetes LLC
Samara, RUS, 443067, Russia
Saratov City Outpatient Clinic # 20
Saratov, RUS, 410038, Russia
Saratov Medical University Faculty Therapy Chair Clinical Hospital # 3
Saratov, RUS, 410054, Russia
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
Smolensk, RUS, 214018, Russia
MHI Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, 150003, Russia
Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, 150062, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Baughman, PhD
Mannkind Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2007
First Posted
October 5, 2007
Study Start
November 1, 2005
Study Completion
July 1, 2006
Last Updated
October 14, 2009
Record last verified: 2009-10