Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin

PHASE3UnknownINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

August 31, 2011

Study Completion Date

September 30, 2011

Conditions
Diabetes Mellitus
Interventions
DRUG

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

DRUG

Regular human insulin

Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.

Trial Locations (74)

1431

"University Multiprofile Hospital for Active Treatment Aleksandrovska", 1 Saint Georgi Sofiysky Saint

4002

University Multiprofile Hospital for Active Treatment at Plovdiv, 15A Vassil Aprilov Blvd

5800

University Multiprofile Hospital for Active Treatment at Pleven, 8A Georgi Kotchev Saint

6003

Multiprofile Hospital for Active Treatment at Stara Zagora, 11 Armeyska Saint

7002

Multiprofile Hospital for Active Treatment at Ruse, 2 Nezavisimost Saint

9010

University Multiprofile Hospital for Active Treatment at Varna, 1 Hristo Smirnensky Saint

10003

Beth Israel Medical Center, Geral J. Friedman Diabetes Institute at New York, 317 East 17th Street Room 7F05 8th Floor

21204

MODEL Clinical Research at Baltimore, 6535 North Charles Street Suite 400N

33021

The Center for Diabetes & Endocrine Care at Hollywood, 1150 N. 35th Ave Suite 590

36024

M.V. Sklifosovskyi Regional Clinical Hospital, Endocrinology Department at Poltava, 23, Shevchenko Saint

48302

Grunberger Diabetes Institute at Bloomfield Hills, 43494 Woodward Ave Suite 208

49023

City Clinical Hospital #9, Endocrinology Department at Dnipropetrovsk, 29, Vorontsova Saint

61070

V.Ya. Danylevskyi Institute for Endocrine Pathology under the Ukrainian Academy of Medical Sciences, Clinical Endocrinology Department at Kharkov, Pomerky 27, Kharkov

76014

Multiple Health Research, LLC. at Arlington, 501 Rita Lane Suite 113

79010

Regional Endocrinology Center, Diabetology Department at Lviv, 1, Ostrozskoho St., Lviv

90404

Coastal Biomedical Research Inc. at Santa Monica, 2001 Santa Monica Blvd Suite 390W

95017

M.O. Semashko Republican Clinical Hospital, Endocrinology Department at Simferopol, 69 Kievskaya Saint

109263

Moscow State Medical Institution Municipal Clinical Hospital #68, 4 Shkuleva Str., Moscow

117036

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

123423

Medical Institution Municipal Clinical Hospital #67, "2 b Salyama Adilya Str., Moscow"

129110

State Institution: Moscow Regional Research Clinical Institute n.a. M.F.Vladimirsky, 61/2 Shchepkina Str., Moscow

163045

State Medical Institution: Arkhangelsk Regional Clinical Hospital, 292 Lomonosova Pr., Arkhangelsk

183047

State Medical Institution: Murmansk Regional Consulting and Diagnostic Center, 6 Pavlova Str., Building 4, Murmansk

185019

State Medical Institution: Republican Hospital, 3 Pirogova Str., Petrozavodsk, ,

193312

St. Petersburg State Medical Institution: City Aleksandrovskaya Hospital, 4 Solidarnosti Pr., Saint Petersburg

194044

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

194354

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

195257

St. Petersburg State Medical Institution: Municipal Hospital of St. Elizabeth, 14 Vavilovykh Str., Saint Petersburg

196211

St. Petersburg State Medical Institution:Municipal Outpatient Clinic #51, 33/35 Kosmonavtov Pr., Saint Petersburg

197022

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

300736

Timisoara Emergency Clinical County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases at Timisoara, 156 Iosif Bulbuca Av

355045

State Medical Institution:Territorial Endocrinology Center, Territorial Diabetology Center, 9 Artema Str., Stavropol

364246

Puerto Medical Center, San Juan

400006

Cluj Emergency Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Cluj-Napoca, 3-5 Clinicilor Saint

410032

Oradea Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Oradea, 33 Republicii Saint

426067

"Municipal Medical Institution: Medical Unit Izhmash, Municipal Endocrinology Center", 1 Truda Str., Izhevsk

430123

Cardiology Private Practice at Bala Mare, 6/72 Independentei Saint

440055

Satu Mare County Hospital, Department of Diabetology and Nutrition Diseases at Satu Mare, 2-3 Eroii Revolutiei Square

443067

"Diabetes Center Company Limited", 56 Sovetskoi Armii Str., Samara

454076

State Medical Healthcare Institution: Chelyabinsk Regional Clinical Hospital, 70 Vorovskogo Str., Medgorodok, Chelyabinsk

603126

State Medical Institution: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko, 190 Rodionova Str., Nizhny Novgorod

620219

State Higher Educational Institution: Ural State Medical Academy under the Federal Agency for Healthcare and Social Development; Family Medicine Clinic, 7 Kluchevskaya Str., Ekaterinburg

625023

State Higher Educational Institution: Tyumen State Medical Academy under the Federal Agency for Healthcare and Social Development, Multifield Clinic, 54 Odesskaya Str., Tyumen

630047

Municipal Medical Institution: Municipal Clinical Hospital #1, Municipal Diabetology Center, 6 Zalesskogo Str., Novosibirsk

644021

Municipal Medical Institution: City Hospital # 2, Municipal Diabetology and Rehabilitation Center, 1 3rd -Transportnaya Str., Omsk

650066

State Medical Institution: Kemerovo Regional Clinical Hospital, 22 Oktyabrsky Pr., Kemerovo

800371

Private Practice at Galati, 25 Constructorilor St, Bl. E5/64

Unknown

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

75390-8858

University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd

T4N 6V7

The Bailey Clinic at Red Deer, #108 3947 50A Avenue

T3B 0M3

Calgary Metabolic Education & Research Centre at Calgary, #23, 4411-16th Avenue Northwest

T5N 3Y6

West Edmonton Diabetes Centre, 10230 142 Saint Northwest # 25, Edmonton

85 - 822

Bydgoszcz Diabetology and Endocrinology Center at Bydgoszcz, Ul. Baczynskiego 17

02 - 341

OSTEOMED Medical Center at Warszawa, Ul. Bialobrzeska 40A

03 - 242

Chair and Department of Internal Medicine and Diabetology, Voivodship Brodnowski Hospital at Warszawa, Ul. Kondratowicza 8

82 -300

Diabetology Clinic for Adults, NZOZ Elblag Diabetology Center, Ul. Krolewiecka 146

35-324

TeMeD - Clinical Trials at Rzeszow, Ul. Mazowiecka 56

90-030

Provincial Centre of Diabetology and Metabolic Diseases, M.Pirogow Provincial Specialist Hospital at Lodz, Ul. Nowa 30/32

40-084

Silesia Osteoporosis Center at Katowice, Ul. Opolska 11/3

34-400

TeMeD - Clinical Trials at Nowy Targ, Ul. Wojska Polskiego 14

15 - 435

NZOZ Specialist Centre of Internal Medicine and Diabetology Malgorzata Arciszewska at Bialystok, Ul. Zamenhofa 10/20

00738

Celis Aguilera 10B, Fajardo

022441

"Nicolae Malaxa Clinical Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Bucharest", 12 Vergului Saint Sector 2

020475

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

010507

Private Practice Nicodiab SRL at Bucharest, 92 Polona St, Bl 17 A+B, Sc. 1, Ap. 2

Syktyvkar

State Medical Institution: Consulting and Diagnostic Center of Komi Republic, Diabetology Center, 6 Kuratova Str., 167981

02175

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

04114

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

All Listed Sponsors
collaborator

OSMOS Clinical Research, Inc

OTHER

collaborator

PSI Pharma Support Intl

UNKNOWN

collaborator

Nextrials, Inc.

INDUSTRY

collaborator

eResearch Technology, Inc.

INDUSTRY

collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

ACM Pivotal Global Central Laboratory

INDUSTRY

lead

Generex Biotechnology Corp.

INDUSTRY