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

Diabetes Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539890
• Other study ID #: MKC-TI-014
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2007
• Last updated: October 12, 2009
• Start date: November 2005
• Est. completion date: July 2006

Study information

• Verified date: October 2009
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Drug:
• Technosphere Insulin

Locations

Country	Name	City	State
Russian Federation	Ural State Medical Academy of Post-Graduate Education Municipal Clinical Hospital # 3	Chelyabinsk	RUS
Russian Federation	NHI Kemerovo Regional Clinical Hospital	Kemerovo	RUS
Russian Federation	Clinical Research Institute of Physic-Chemical Medicine Hospital # 29	Moscow	RUS
Russian Federation	Moscow City Clinical Hospital # 20	Moscow	RUS
Russian Federation	Moscow Hospital of Glavmosstroy State Unitary Enterprise Medical Centre Medical Sanitary Unit #47	Moscow	RUS
Russian Federation	Moscow Medical Academy	Moscow	RUS
Russian Federation	Moscow State Medical Stomatology University Municipal Hospital # 63 Endocrinology Diabetology	Moscow	RUS
Russian Federation	Moscow State Medico-Stomatological University City Hospital # 23	Moscow	RUS
Russian Federation	Municipal Clinical Hospital #13	Moscow	RUS
Russian Federation	NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70	Moscow	RUS
Russian Federation	NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense	Moscow	RUS
Russian Federation	Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes	Moscow	RUS
Russian Federation	Russian State Medical University	Moscow	RUS
Russian Federation	Russian State Medical University Central Clinical Hospital Russian Science Academy	Moscow	RUS
Russian Federation	Russian State Medical University City Hospital # 4	Moscow	RUS
Russian Federation	Sechenov Moscow Medical Academy	Moscow	RUS
Russian Federation	SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology	Moscow	RUS
Russian Federation	Nizhni Novgorod regional hospital na Semashko	N Novgorod	RUS
Russian Federation	Center Diabetes LLC	Samara	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	Central Medical Sanitary Unit #122	St Petersburg	RUS
Russian Federation	City Outpatient Clinic # 34	St Petersburg	RUS
Russian Federation	Pavlov State Medical Univ of St Petersburg	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	St Petersburg NHI City Polytclinic #77 City Diabetological Center #4	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	MHI Clinical Hospital for Emergency Care na NV Soloviev	Yaroslavl	RUS
Russian Federation	Yaroslavl Regional Clinical Hospital	Yaroslavl	RUS

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in HbA1c from baseline to treatment week 24		24 weeks