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Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Technosphere Insulin
Metformin & Secretagogues
Technosphere Insulin & Metformin
Sponsored by
Mannkind Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

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

Inclusion Criteria: Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks. Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria HbA1c >or= to 7.5% and < or= to 11.0% BMI < or = to 40kg/m2. FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70% Exclusion Criteria: Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings Evidence of serious complications of diabetes (e.g. autonomic neuropathy)

Sites / Locations

  • Radiant Research-Birmingham
  • Parkway Medical Center
  • Redpoint Research
  • Arizona Center for Clinical Research
  • International Clinical Research Network
  • National Jewish Medical & Research Center
  • Creekside Endocrine Associates
  • Jennifer Hone MD
  • Chase Medical Research, LLC
  • Center for Diabetes & Endocrine Care
  • International Research Associates LLC
  • Cedar-Crosse Research Center
  • John H Stoger Jr Hospital of Cook County
  • Clintell Inc
  • James A Dicke MDPA
  • East Coast Clinical Research Inc
  • Wayne State University
  • Michigan Institute of Medicine
  • Clayton Medical Research
  • Raidant Research-St Louis
  • Washington University School of Medicine
  • Creighton Diabetes Center
  • Lovelace Scientific Resources (Albuquerque)
  • Winthrop University Hospital
  • North Shore Diabetes and Endocrine Associates
  • Metrolina Internal Medicine
  • Charlotte Clinical Research Inc
  • Sensenbrenner Primary Care
  • Duke Medical Center
  • Dayton Clinical Research
  • Providence Health Partners - Center of Clinical Research
  • Radiant Research
  • Upstate Pharmaceutical Research
  • Collierville Medical Specialists
  • Memphis Internal Medicine (Kathawala)
  • GoodLife Medical Center PLLC
  • Baylor Endocrine Center
  • Quality Assurance Research Center Inc
  • Clinical Trials of Texas Inc
  • Covenant Clinic Research
  • Diabetes & Glandular Disease Research Assoc PA
  • SAM Clinical Research Center
  • Cedar Research
  • Hospital Interzonal de Agudos Pedro Fiorito
  • Centro Endocrinologic Tiempo
  • Hospital Italiano de Buenos Aires
  • Cons Asoc de Endocrinologia
  • CIMeL
  • Hospital de Clinicas de Porto Alegre
  • Hospital Sao Lucas da PUCRS
  • Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
  • Hospital Guilherme Alvaro
  • CPClin-Centro de Pesquisas Clinicas
  • UNIFRSP
  • Hospital do Rim e Hipertensao
  • Instituto de Pesquisa Clinica e Medicina Avancada
  • Quest Clinical Trials
  • Lifestyle Metabolism Center
  • Lifestyle Metabolism Center
  • Lifestyle Metabolism Center
  • Trial Management Group Inc (Henein
  • Unimedico Management
  • Hospital Padre Alberto Hurtado
  • Hospital Clinico Pontificia Universidad Catolica de Chile
  • Hospital del Salvador
  • Instituto de Informacion de Tramiento y Educacion en Salud
  • Diabetologicka a interni ambulance
  • Institute for Clinical and Exp Medicine
  • University Hospital Na Bulovce
  • Diabetologicka ambulance (Chmura)
  • Interní a diabetologická Outpatient
  • II interni klinika FN Kralovske Vinohrady
  • Endokrinologicky ustav
  • 3rd Medical Department General Faculty Hospital
  • Instituto Mexicano de Investigacion
  • Hospital Universitario Dr Jose E Gonzalez
  • Hospital Santa Engracia-CIMA
  • Centro de Estudios en Diabetes
  • Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio
  • OCA-MIRC
  • Klinika Endocrinologii Diabetologii I
  • NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
  • Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
  • Instytut Centrum Zdrowia (009) Matki Polki
  • Spzital Kolejowy imm Wlodzimierza Roeflera
  • Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
  • Centrum Leczenia Chorob cywilizacyjnych
  • NHI Kemerovo Regional Clinical Hospital
  • NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
  • NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
  • NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
  • NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
  • 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
  • TUV Medico-Military Academy
  • St Petersburg NHI Municipal Multi-Speciality Hospital # 2
  • MHI Clinical Hospital for Emergency Care na NV Soloviev
  • NHI Yaroslavl Regional Clinical Hospital
  • NI Central Clinical Hospital of RAS
  • Complejo Hospitalario Nuestra Senora de Valme
  • Hospital Clinic I Provincial
  • Hospital Universitario de la Princessa
  • Hospital Ramon y Cajal
  • Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia
  • Bukovinian State Medical University Dept of Clinical Immun
  • Dniepropetrovsh State Medical Academy
  • Donetsk State Medical University
  • Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin)
  • Railway Clinical Hospital on Donetsk Station
  • Chair Family Med of National Med University
  • Institute of Endocrinology and Metabolism
  • Ukr Scientifically Practical Centre of Endocrine Surgery
  • Odessa State Medical University Dept of Gen Practice and Med Rehab
  • Odessa Reg. Clinical Hosp Outpatient Department
  • Odessa State Med Dept of Family Med and Gen Practice
  • Vinnitsa State Medical University
  • Outpatient Clinic of Family Physician "Rusanovka"
  • Public Institution City Policlinic #20 Odessa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Technosphere Insulin

Metformin & Secretagogues

Technosphere & Metformin

Outcomes

Primary Outcome Measures

Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue

Secondary Outcome Measures

Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue
(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)
Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)

Full Information

First Posted
May 31, 2006
Last Updated
October 9, 2014
Sponsor
Mannkind Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00332488
Brief Title
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Official Title
A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mannkind Corporation

4. Oversight

5. Study Description

Brief Summary
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Technosphere Insulin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Metformin & Secretagogues
Arm Title
3
Arm Type
Experimental
Arm Description
Technosphere & Metformin
Intervention Type
Drug
Intervention Name(s)
Technosphere Insulin
Intervention Description
Inhalation, 15U/30U, prandial
Intervention Type
Drug
Intervention Name(s)
Metformin & Secretagogues
Intervention Description
Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
Intervention Type
Drug
Intervention Name(s)
Technosphere Insulin & Metformin
Intervention Description
Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets
Primary Outcome Measure Information:
Title
Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue
Description
(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)
Time Frame
Baseline to Week 12
Title
Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)
Time Frame
Week 24

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: Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks. Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria HbA1c >or= to 7.5% and < or= to 11.0% BMI < or = to 40kg/m2. FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70% Exclusion Criteria: Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings Evidence of serious complications of diabetes (e.g. autonomic neuropathy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
For MannKind sponsored trials, the Overall Study Official is the Chief Scientific Officer
Organizational Affiliation
Mannkind Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Parkway Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Redpoint Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Arizona Center for Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
International Clinical Research Network
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
National Jewish Medical & Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Creekside Endocrine Associates
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Jennifer Hone MD
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Center for Diabetes & Endocrine Care
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
International Research Associates LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Cedar-Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
John H Stoger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Clintell Inc
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
James A Dicke MDPA
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
East Coast Clinical Research Inc
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Michigan Institute of Medicine
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Clayton Medical Research
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Raidant Research-St Louis
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Lovelace Scientific Resources (Albuquerque)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
North Shore Diabetes and Endocrine Associates
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Metrolina Internal Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Charlotte Clinical Research Inc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Sensenbrenner Primary Care
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Duke Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Providence Health Partners - Center of Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Radiant Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Upstate Pharmaceutical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Collierville Medical Specialists
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Memphis Internal Medicine (Kathawala)
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
GoodLife Medical Center PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Baylor Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Quality Assurance Research Center Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Clinical Trials of Texas Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Covenant Clinic Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Diabetes & Glandular Disease Research Assoc PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
SAM Clinical Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Cedar Research
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hospital Interzonal de Agudos Pedro Fiorito
City
Avellaneda
State/Province
Buenos Aires
ZIP/Postal Code
B1870ARG
Country
Argentina
Facility Name
Centro Endocrinologic Tiempo
City
Buenos Aires
ZIP/Postal Code
C1117ABH
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Cons Asoc de Endocrinologia
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
CIMeL
City
Buenos Aires
Country
Argentina
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Hospital Guilherme Alvaro
City
Santos
ZIP/Postal Code
11045-904
Country
Brazil
Facility Name
CPClin-Centro de Pesquisas Clinicas
City
Sao Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
UNIFRSP
City
Sao Paulo
ZIP/Postal Code
04020-050
Country
Brazil
Facility Name
Hospital do Rim e Hipertensao
City
Sao Paulo
ZIP/Postal Code
04025-011
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica e Medicina Avancada
City
Sao Paulo
ZIP/Postal Code
05437-010
Country
Brazil
Facility Name
Quest Clinical Trials
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 1A1
Country
Canada
Facility Name
Lifestyle Metabolism Center
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Lifestyle Metabolism Center
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Lifestyle Metabolism Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4R 2G4
Country
Canada
Facility Name
Trial Management Group Inc (Henein
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4T 1N5
Country
Canada
Facility Name
Unimedico Management
City
Richmond Hill
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Hospital Padre Alberto Hurtado
City
Santiago
State/Province
Region Metropolitana
Country
Chile
Facility Name
Hospital Clinico Pontificia Universidad Catolica de Chile
City
Santiago
Country
Chile
Facility Name
Hospital del Salvador
City
Santiago
Country
Chile
Facility Name
Instituto de Informacion de Tramiento y Educacion en Salud
City
Santiago
Country
Chile
Facility Name
Diabetologicka a interni ambulance
City
Ostrava-Kuncice
State/Province
CZE
ZIP/Postal Code
70702
Country
Czech Republic
Facility Name
Institute for Clinical and Exp Medicine
City
Prague 4
State/Province
CZE
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
University Hospital Na Bulovce
City
Prague 8
State/Province
CZE
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
Diabetologicka ambulance (Chmura)
City
Ostrava
ZIP/Postal Code
70200
Country
Czech Republic
Facility Name
Interní a diabetologická Outpatient
City
Ostrava
ZIP/Postal Code
70900
Country
Czech Republic
Facility Name
II interni klinika FN Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Endokrinologicky ustav
City
Praha 1
ZIP/Postal Code
11694
Country
Czech Republic
Facility Name
3rd Medical Department General Faculty Hospital
City
Praha 2
ZIP/Postal Code
12801
Country
Czech Republic
Facility Name
Instituto Mexicano de Investigacion
City
Mexico City
State/Province
Durango
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Hospital Universitario Dr Jose E Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Santa Engracia-CIMA
City
Garza Garcia
ZIP/Postal Code
66260
Country
Mexico
Facility Name
Centro de Estudios en Diabetes
City
Mexico City
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio
City
Mexico City
ZIP/Postal Code
06726
Country
Mexico
Facility Name
OCA-MIRC
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Klinika Endocrinologii Diabetologii I
City
Bialystock
State/Province
POL
ZIP/Postal Code
15-276
Country
Poland
Facility Name
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
City
Bialystok
State/Province
POL
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
City
Krakow
State/Province
POL
ZIP/Postal Code
31 501
Country
Poland
Facility Name
Instytut Centrum Zdrowia (009) Matki Polki
City
Lodz
State/Province
POL
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Spzital Kolejowy imm Wlodzimierza Roeflera
City
Pruszkow
State/Province
POL
ZIP/Postal Code
05-800
Country
Poland
Facility Name
Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
City
Warsaw
ZIP/Postal Code
03 580
Country
Poland
Facility Name
Centrum Leczenia Chorob cywilizacyjnych
City
Warszawa
ZIP/Postal Code
02 777
Country
Poland
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
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
NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
City
Moscow
State/Province
RUS
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
City
Moscow
State/Province
RUS
ZIP/Postal Code
129110
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
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
NHI Yaroslavl Regional Clinical Hospital
City
Yaroslavl
State/Province
RUS
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
NI Central Clinical Hospital of RAS
City
Moscow
ZIP/Postal Code
117 593
Country
Russian Federation
Facility Name
Complejo Hospitalario Nuestra Senora de Valme
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de la Princessa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Bukovinian State Medical University Dept of Clinical Immun
City
Chernivtsy
State/Province
UKR
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
Dniepropetrovsh State Medical Academy
City
Dniepropetrovsk
State/Province
UKR
ZIP/Postal Code
49023
Country
Ukraine
Facility Name
Donetsk State Medical University
City
Donetsk
State/Province
UKR
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin)
City
Donetsk
State/Province
UKR
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
Railway Clinical Hospital on Donetsk Station
City
Donetsk
State/Province
UKR
ZIP/Postal Code
83114
Country
Ukraine
Facility Name
Chair Family Med of National Med University
City
Kiev
State/Province
UKR
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Institute of Endocrinology and Metabolism
City
Kiev
State/Province
UKR
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Ukr Scientifically Practical Centre of Endocrine Surgery
City
Kiev
State/Province
UKR
ZIP/Postal Code
2175
Country
Ukraine
Facility Name
Odessa State Medical University Dept of Gen Practice and Med Rehab
City
Odessa
State/Province
UKR
ZIP/Postal Code
65009
Country
Ukraine
Facility Name
Odessa Reg. Clinical Hosp Outpatient Department
City
Odessa
State/Province
UKR
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Odessa State Med Dept of Family Med and Gen Practice
City
Odessa
State/Province
UKR
ZIP/Postal Code
65039
Country
Ukraine
Facility Name
Vinnitsa State Medical University
City
Vinnitsa
State/Province
UKR
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Outpatient Clinic of Family Physician "Rusanovka"
City
Kiev
ZIP/Postal Code
02147
Country
Ukraine
Facility Name
Public Institution City Policlinic #20 Odessa
City
Odessa
ZIP/Postal Code
65114
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

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