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

Phase 3

Completed

• Conditions: Diabetes Type 2

• Registration Number: NCT00539890
• Lead Sponsor: Mannkind Corporation

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study Completion: 2006-07
• Study First Submitted: 2007-10-03
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-05
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-12
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change in HbA1c from baseline to treatment week 24	24 weeks

Trial Locations

Locations (32)

Russian State Medical University City Hospital # 4; 🇷🇺 Moscow, RUS, Russian Federation

Ural State Medical Academy of Post-Graduate Education Municipal Clinical Hospital # 3; 🇷🇺 Chelyabinsk, RUS, Russian Federation

Moscow Medical Academy; 🇷🇺 Moscow, RUS, Russian Federation

SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology; 🇷🇺 Moscow, RUS, Russian Federation

Municipal Clinical Hospital #13; 🇷🇺 Moscow, RUS, Russian Federation

Center Diabetes LLC; 🇷🇺 Samara, RUS, Russian Federation

Yaroslavl Regional Clinical Hospital; 🇷🇺 Yaroslavl, RUS, Russian Federation

Clinical Research Institute of Physic-Chemical Medicine Hospital # 29; 🇷🇺 Moscow, RUS, Russian Federation

NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70; 🇷🇺 Moscow, RUS, Russian Federation

City Outpatient Clinic # 34; 🇷🇺 St Petersburg, RUS, Russian Federation

MHI Clinical Hospital for Emergency Care na NV Soloviev; 🇷🇺 Yaroslavl, RUS, Russian Federation

NHI Kemerovo Regional Clinical Hospital; 🇷🇺 Kemerovo, RUS, Russian Federation

NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense; 🇷🇺 Moscow, RUS, Russian Federation

Moscow State Medico-Stomatological University City Hospital # 23; 🇷🇺 Moscow, RUS, Russian Federation

Russian State Medical University; 🇷🇺 Moscow, RUS, Russian Federation

Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes; 🇷🇺 Moscow, RUS, Russian Federation

Moscow Hospital of Glavmosstroy State Unitary Enterprise Medical Centre Medical Sanitary Unit #47; 🇷🇺 Moscow, RUS, Russian Federation

Russian State Medical University Central Clinical Hospital Russian Science Academy; 🇷🇺 Moscow, RUS, Russian Federation

Sechenov Moscow Medical Academy; 🇷🇺 Moscow, RUS, Russian Federation

Moscow State Medical Stomatology University Municipal Hospital # 63 Endocrinology Diabetology; 🇷🇺 Moscow, RUS, Russian Federation

Moscow City Clinical Hospital # 20; 🇷🇺 Moscow, RUS, Russian Federation

Nizhni Novgorod regional hospital na Semashko; 🇷🇺 N Novgorod, RUS, Russian Federation

Saratov City Outpatient Clinic # 20; 🇷🇺 Saratov, RUS, Russian Federation

Saratov Medical University Faculty Therapy Chair Clinical Hospital # 3; 🇷🇺 Saratov, RUS, Russian Federation

NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital; 🇷🇺 Smolensk, RUS, Russian Federation

St Petersburg NHI City Polytclinic #77 City Diabetological Center #4; 🇷🇺 St Petersburg, RUS, Russian Federation

Central Medical Sanitary Unit #122; 🇷🇺 St Petersburg, RUS, Russian Federation

SPb Diabetological Center; 🇷🇺 St Petersburg, RUS, Russian Federation

St Petersburg Medical Academy St Elizabeth Hospital; 🇷🇺 St Petersburg, RUS, Russian Federation

Pavlov State Medical Univ of St Petersburg; 🇷🇺 St Petersburg, RUS, Russian Federation

TUV Medico-Military Academy; 🇷🇺 St Petersburg, RUS, Russian Federation

St Petersburg NHI Municipal Multi-Speciality Hospital # 2; 🇷🇺 St. Petersburg, RUS, Russian Federation