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

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Technosphere Insulin
Sponsored by
Mannkind Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ural State Medical Academy of Post-Graduate Education Municipal Clinical Hospital # 3
  • NHI Kemerovo Regional Clinical Hospital
  • NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
  • Moscow State Medico-Stomatological University City Hospital # 23
  • Russian State Medical University
  • Clinical Research Institute of Physic-Chemical Medicine Hospital # 29
  • NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
  • Russian State Medical University City Hospital # 4
  • Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
  • Moscow Hospital of Glavmosstroy State Unitary Enterprise Medical Centre Medical Sanitary Unit #47
  • Russian State Medical University Central Clinical Hospital Russian Science Academy
  • Sechenov Moscow Medical Academy
  • Moscow Medical Academy
  • SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
  • Moscow State Medical Stomatology University Municipal Hospital # 63 Endocrinology Diabetology
  • Moscow City Clinical Hospital # 20
  • Municipal Clinical Hospital #13
  • Nizhni Novgorod regional hospital na Semashko
  • Center Diabetes LLC
  • Saratov City Outpatient Clinic # 20
  • Saratov Medical University Faculty Therapy Chair Clinical Hospital # 3
  • NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
  • St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
  • Central Medical Sanitary Unit #122
  • SPb Diabetological Center
  • St Petersburg Medical Academy St Elizabeth Hospital
  • Pavlov State Medical Univ of St Petersburg
  • City Outpatient Clinic # 34
  • TUV Medico-Military Academy
  • St Petersburg NHI Municipal Multi-Speciality Hospital # 2
  • MHI Clinical Hospital for Emergency Care na NV Soloviev
  • Yaroslavl Regional Clinical Hospital

Outcomes

Primary Outcome Measures

Mean change in HbA1c from baseline to treatment week 24

Secondary Outcome Measures

Full Information

First Posted
October 3, 2007
Last Updated
October 12, 2009
Sponsor
Mannkind Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00539890
Brief Title
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

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mannkind Corporation

4. Oversight

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Technosphere Insulin
Primary Outcome Measure Information:
Title
Mean change in HbA1c from baseline to treatment week 24
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Baughman, PhD
Organizational Affiliation
Mannkind Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Ural State Medical Academy of Post-Graduate Education Municipal Clinical Hospital # 3
City
Chelyabinsk
State/Province
RUS
ZIP/Postal Code
454021
Country
Russian Federation
Facility Name
NHI Kemerovo Regional Clinical Hospital
City
Kemerovo
State/Province
RUS
ZIP/Postal Code
650061
Country
Russian Federation
Facility Name
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
City
Moscow
State/Province
RUS
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Moscow State Medico-Stomatological University City Hospital # 23
City
Moscow
State/Province
RUS
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Russian State Medical University
City
Moscow
State/Province
RUS
ZIP/Postal Code
109263
Country
Russian Federation
Facility Name
Clinical Research Institute of Physic-Chemical Medicine Hospital # 29
City
Moscow
State/Province
RUS
ZIP/Postal Code
111020
Country
Russian Federation
Facility Name
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
City
Moscow
State/Province
RUS
ZIP/Postal Code
111399
Country
Russian Federation
Facility Name
Russian State Medical University City Hospital # 4
City
Moscow
State/Province
RUS
ZIP/Postal Code
113093
Country
Russian Federation
Facility Name
Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
City
Moscow
State/Province
RUS
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Moscow Hospital of Glavmosstroy State Unitary Enterprise Medical Centre Medical Sanitary Unit #47
City
Moscow
State/Province
RUS
ZIP/Postal Code
117192
Country
Russian Federation
Facility Name
Russian State Medical University Central Clinical Hospital Russian Science Academy
City
Moscow
State/Province
RUS
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
Sechenov Moscow Medical Academy
City
Moscow
State/Province
RUS
ZIP/Postal Code
119881
Country
Russian Federation
Facility Name
Moscow Medical Academy
City
Moscow
State/Province
RUS
ZIP/Postal Code
123478
Country
Russian Federation
City
Moscow
State/Province
RUS
ZIP/Postal Code
125315
Country
Russian Federation
Facility Name
SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
City
Moscow
State/Province
RUS
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Moscow State Medical Stomatology University Municipal Hospital # 63 Endocrinology Diabetology
City
Moscow
State/Province
RUS
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital # 20
City
Moscow
State/Province
RUS
ZIP/Postal Code
129327
Country
Russian Federation
Facility Name
Municipal Clinical Hospital #13
City
Moscow
State/Province
RUS
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Nizhni Novgorod regional hospital na Semashko
City
N Novgorod
State/Province
RUS
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Center Diabetes LLC
City
Samara
State/Province
RUS
ZIP/Postal Code
443067
Country
Russian Federation
Facility Name
Saratov City Outpatient Clinic # 20
City
Saratov
State/Province
RUS
ZIP/Postal Code
410038
Country
Russian Federation
Facility Name
Saratov Medical University Faculty Therapy Chair Clinical Hospital # 3
City
Saratov
State/Province
RUS
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
City
Smolensk
State/Province
RUS
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
193012
Country
Russian Federation
Facility Name
Central Medical Sanitary Unit #122
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
SPb Diabetological Center
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
St Petersburg Medical Academy St Elizabeth Hospital
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Pavlov State Medical Univ of St Petersburg
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
City Outpatient Clinic # 34
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
197198
Country
Russian Federation
Facility Name
TUV Medico-Military Academy
City
St Petersburg
State/Province
RUS
ZIP/Postal Code
198013
Country
Russian Federation
Facility Name
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
City
St. Petersburg
State/Province
RUS
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
MHI Clinical Hospital for Emergency Care na NV Soloviev
City
Yaroslavl
State/Province
RUS
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Hospital
City
Yaroslavl
State/Province
RUS
ZIP/Postal Code
150062
Country
Russian Federation

12. IPD Sharing Statement

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

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