Clinical trial NCT00539890: Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Type 2
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2007-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


Eligibility 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

Primary outcomes:
measure: Mean change in HbA1c from baseline to treatment week 24
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Ural State Medical Academy of Post-Graduate Education Municipal Clinical Hospital # 3
state: RUS
city: Kemerovo
country: Russian Federation
facility: NHI Kemerovo Regional Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow State Medico-Stomatological University City Hospital # 23
state: RUS
city: Moscow
country: Russian Federation
facility: Russian State Medical University
state: RUS
city: Moscow
country: Russian Federation
facility: Clinical Research Institute of Physic-Chemical Medicine Hospital # 29
state: RUS
city: Moscow
country: Russian Federation
facility: NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
state: RUS
city: Moscow
country: Russian Federation
facility: Russian State Medical University City Hospital # 4
state: RUS
city: Moscow
country: Russian Federation
facility: Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow Hospital of Glavmosstroy State Unitary Enterprise Medical Centre Medical Sanitary Unit #47
state: RUS
city: Moscow
country: Russian Federation
facility: Russian State Medical University Central Clinical Hospital Russian Science Academy
state: RUS
city: Moscow
country: Russian Federation
facility: Sechenov Moscow Medical Academy
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow Medical Academy
state: RUS
city: Moscow
country: Russian Federation
state: RUS
city: Moscow
country: Russian Federation
facility: SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow State Medical Stomatology University Municipal Hospital # 63 Endocrinology Diabetology
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital # 20
state: RUS
city: Moscow
country: Russian Federation
facility: Municipal Clinical Hospital #13
state: RUS
city: N Novgorod
country: Russian Federation
facility: Nizhni Novgorod regional hospital na Semashko
state: RUS
city: Samara
country: Russian Federation
facility: Center Diabetes LLC
state: RUS
city: Saratov
country: Russian Federation
facility: Saratov City Outpatient Clinic # 20
state: RUS
city: Saratov
country: Russian Federation
facility: Saratov Medical University Faculty Therapy Chair Clinical Hospital # 3
state: RUS
city: Smolensk
country: Russian Federation
facility: NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
state: RUS
city: St Petersburg
country: Russian Federation
facility: St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
state: RUS
city: St Petersburg
country: Russian Federation
facility: Central Medical Sanitary Unit #122
state: RUS
city: St Petersburg
country: Russian Federation
facility: SPb Diabetological Center
state: RUS
city: St Petersburg
country: Russian Federation
facility: St Petersburg Medical Academy St Elizabeth Hospital
state: RUS
city: St Petersburg
country: Russian Federation
facility: Pavlov State Medical Univ of St Petersburg
state: RUS
city: St Petersburg
country: Russian Federation
facility: City Outpatient Clinic # 34
state: RUS
city: St Petersburg
country: Russian Federation
facility: TUV Medico-Military Academy
state: RUS
city: St. Petersburg
country: Russian Federation
facility: St Petersburg NHI Municipal Multi-Speciality Hospital # 2
state: RUS
city: Yaroslavl
country: Russian Federation
facility: MHI Clinical Hospital for Emergency Care na NV Soloviev
state: RUS
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital
state: RUS
Study officials:
affiliation: Mannkind Corporation
name: Robert Baughman, PhD
role: STUDY_DIRECTOR
References: