500
Participants
Start Date
April 30, 2008
Primary Completion Date
August 31, 2011
Study Completion Date
September 30, 2011
Generex Oral-lyn™
Generex Oral-lyn™ spray in a split-dose fashion (half the dose immediately prior to the meal and half the dose immediately after the meal) + BID NPH insulin AM and PM as pre-randomization dose
Regular human insulin
Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.
"University Multiprofile Hospital for Active Treatment Aleksandrovska", 1 Saint Georgi Sofiysky Saint
University Multiprofile Hospital for Active Treatment at Plovdiv, 15A Vassil Aprilov Blvd
University Multiprofile Hospital for Active Treatment at Pleven, 8A Georgi Kotchev Saint
Multiprofile Hospital for Active Treatment at Stara Zagora, 11 Armeyska Saint
Multiprofile Hospital for Active Treatment at Ruse, 2 Nezavisimost Saint
University Multiprofile Hospital for Active Treatment at Varna, 1 Hristo Smirnensky Saint
Beth Israel Medical Center, Geral J. Friedman Diabetes Institute at New York, 317 East 17th Street Room 7F05 8th Floor
MODEL Clinical Research at Baltimore, 6535 North Charles Street Suite 400N
The Center for Diabetes & Endocrine Care at Hollywood, 1150 N. 35th Ave Suite 590
M.V. Sklifosovskyi Regional Clinical Hospital, Endocrinology Department at Poltava, 23, Shevchenko Saint
Grunberger Diabetes Institute at Bloomfield Hills, 43494 Woodward Ave Suite 208
City Clinical Hospital #9, Endocrinology Department at Dnipropetrovsk, 29, Vorontsova Saint
V.Ya. Danylevskyi Institute for Endocrine Pathology under the Ukrainian Academy of Medical Sciences, Clinical Endocrinology Department at Kharkov, Pomerky 27, Kharkov
Multiple Health Research, LLC. at Arlington, 501 Rita Lane Suite 113
Regional Endocrinology Center, Diabetology Department at Lviv, 1, Ostrozskoho St., Lviv
Coastal Biomedical Research Inc. at Santa Monica, 2001 Santa Monica Blvd Suite 390W
M.O. Semashko Republican Clinical Hospital, Endocrinology Department at Simferopol, 69 Kievskaya Saint
Moscow State Medical Institution Municipal Clinical Hospital #68, 4 Shkuleva Str., Moscow
Federal State Institution: Endocrinology Research Center under the Federal Agency for High-Tech Medical Care, Department of Therapeutic and Surgical Methods for Treatment of Diabetic Foot, 11 Dmitriya Ulyanova Str., Moscow
Federal State Institution: Endocrinology Research Center under the Federal Agency for High-Tech Medical Care, Department of Training and Psychosocial Rehabilitation of Patients with Diabetes Mellitus, 11 Dmitriya Ulyanova Str., Moscow
Medical Institution Municipal Clinical Hospital #67, "2 b Salyama Adilya Str., Moscow"
State Institution: Moscow Regional Research Clinical Institute n.a. M.F.Vladimirsky, 61/2 Shchepkina Str., Moscow
State Medical Institution: Arkhangelsk Regional Clinical Hospital, 292 Lomonosova Pr., Arkhangelsk
State Medical Institution: Murmansk Regional Consulting and Diagnostic Center, 6 Pavlova Str., Building 4, Murmansk
State Medical Institution: Republican Hospital, 3 Pirogova Str., Petrozavodsk, ,
St. Petersburg State Medical Institution: City Aleksandrovskaya Hospital, 4 Solidarnosti Pr., Saint Petersburg
Federal State Medical Institution: All-Russia Center for Urgent Care and Radiation Medicine n.a. A.M. Nikiforov under the Russian Emergency Control Ministry, 4/2 Lebedeva Str., St.Petersburg
St. Petersburg State Medical Institution: St. George Municipal Hospital, 1 Severny Pr., St.Petersburg
St. Petersburg State Medical Institution: Municipal Consulting and Diagnostic Center #1, St. Petersburg Territorial Diabetology Center, 10 Siqueirosa Str., Saint Petersburg
St. Petersburg State Medical Institution: Municipal Multifield Hospital #2, 5 Uchebny Per., Saint Petersburg
St. Petersburg State Medical Institution: Municipal Hospital of St. Elizabeth, 14 Vavilovykh Str., Saint Petersburg
St. Petersburg State Medical Institution:Municipal Outpatient Clinic #51, 33/35 Kosmonavtov Pr., Saint Petersburg
State Higher Educational Institution: St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development, 6/8 L. Tolstogo Str., Saint Petersburg
Timisoara Emergency Clinical County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases at Timisoara, 156 Iosif Bulbuca Av
State Medical Institution:Territorial Endocrinology Center, Territorial Diabetology Center, 9 Artema Str., Stavropol
Puerto Medical Center, San Juan
Cluj Emergency Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Cluj-Napoca, 3-5 Clinicilor Saint
Oradea Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Oradea, 33 Republicii Saint
"Municipal Medical Institution: Medical Unit Izhmash, Municipal Endocrinology Center", 1 Truda Str., Izhevsk
Cardiology Private Practice at Bala Mare, 6/72 Independentei Saint
Satu Mare County Hospital, Department of Diabetology and Nutrition Diseases at Satu Mare, 2-3 Eroii Revolutiei Square
"Diabetes Center Company Limited", 56 Sovetskoi Armii Str., Samara
State Medical Healthcare Institution: Chelyabinsk Regional Clinical Hospital, 70 Vorovskogo Str., Medgorodok, Chelyabinsk
State Medical Institution: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko, 190 Rodionova Str., Nizhny Novgorod
State Higher Educational Institution: Ural State Medical Academy under the Federal Agency for Healthcare and Social Development; Family Medicine Clinic, 7 Kluchevskaya Str., Ekaterinburg
State Higher Educational Institution: Tyumen State Medical Academy under the Federal Agency for Healthcare and Social Development, Multifield Clinic, 54 Odesskaya Str., Tyumen
Municipal Medical Institution: Municipal Clinical Hospital #1, Municipal Diabetology Center, 6 Zalesskogo Str., Novosibirsk
Municipal Medical Institution: City Hospital # 2, Municipal Diabetology and Rehabilitation Center, 1 3rd -Transportnaya Str., Omsk
State Medical Institution: Kemerovo Regional Clinical Hospital, 22 Oktyabrsky Pr., Kemerovo
Private Practice at Galati, 25 Constructorilor St, Bl. E5/64
Physicians Research Group at Indianapolis, 7400 North Shadeland Ave
Instituto de Endocrinologia IEMYR, Avenida La Coruña Nº 6337 Y San Ignacio
Clinical Research, Puerto Rico, San Juan
University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd
The Bailey Clinic at Red Deer, #108 3947 50A Avenue
Calgary Metabolic Education & Research Centre at Calgary, #23, 4411-16th Avenue Northwest
West Edmonton Diabetes Centre, 10230 142 Saint Northwest # 25, Edmonton
Bydgoszcz Diabetology and Endocrinology Center at Bydgoszcz, Ul. Baczynskiego 17
OSTEOMED Medical Center at Warszawa, Ul. Bialobrzeska 40A
Chair and Department of Internal Medicine and Diabetology, Voivodship Brodnowski Hospital at Warszawa, Ul. Kondratowicza 8
Diabetology Clinic for Adults, NZOZ Elblag Diabetology Center, Ul. Krolewiecka 146
TeMeD - Clinical Trials at Rzeszow, Ul. Mazowiecka 56
Provincial Centre of Diabetology and Metabolic Diseases, M.Pirogow Provincial Specialist Hospital at Lodz, Ul. Nowa 30/32
Silesia Osteoporosis Center at Katowice, Ul. Opolska 11/3
TeMeD - Clinical Trials at Nowy Targ, Ul. Wojska Polskiego 14
NZOZ Specialist Centre of Internal Medicine and Diabetology Malgorzata Arciszewska at Bialystok, Ul. Zamenhofa 10/20
Celis Aguilera 10B, Fajardo
"Nicolae Malaxa Clinical Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Bucharest", 12 Vergului Saint Sector 2
National Institute of Diabetes, Nutrition and Metabolic Diseases, 1st Clinical Department of Diabetes, Nutrition and Metabolic Diseases at Bucharest, 5-7 Ion Movila Saint Sector 2
Private Practice Nicodiab SRL at Bucharest, 92 Polona St, Bl 17 A+B, Sc. 1, Ap. 2
State Medical Institution: Consulting and Diagnostic Center of Komi Republic, Diabetology Center, 6 Kuratova Str., 167981
Ukrainian Research and Development Center for Endocrine Surgery and Endocrine Organ and Tissue Transplantation under the Ministry of Health of Ukraine, General Endocrine Pathology Department at Kiev, 121, Kharkovskoe Shosse, Kiev
V.P. Komisarenko Institute for Endocrinology and Metabolism under the Ukrainian Academy of Medical Sciences, Clinical Diabetology Department at Kiev, 69, Vyshgorodskaya St., Kiev
V.P. Komisarenko Institute for Endocrinology and Metabolism under the Ukrainian Academy of Medical Sciences, General Endocrine Pathology Department at Kiev, 69, Vyshgorodskaya St., Kiev
Lead Sponsor
Collaborators (2)
OSMOS Clinical Research, Inc
OTHER
PSI Pharma Support Intl
UNKNOWN
Nextrials, Inc.
INDUSTRY
eResearch Technology, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY
ACM Pivotal Global Central Laboratory
INDUSTRY
Generex Biotechnology Corp.
INDUSTRY