A 26-Week, Open-Label, Randomized, Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin In Subjects With Type-1 Diabetes Mellitus

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

Sponsors

Lead sponsor: Generex Biotechnology Corp.

Collaborator: OSMOS Clinical Research, Inc
PSI Pharma Support Intl
Nextrials, Inc.
eResearch Technology, Inc.
Hoffmann-La Roche
ACM Pivotal Global Central Laboratory

Source Generex Biotechnology Corp.
Brief Summary

To compare the efficacy of Generex Oral-lyn™ RapidMist™ System and standard regular human insulin therapy as measured by HbA1c, in type-1 diabetes mellitus subjects on BID NPH intermediate acting insulin therapy.

Detailed Description

This is a 26 week open-label, randomized, multi-center, active comparator study to compare oral spray insulin (Generex Oral-lyn™) with regular human insulin therapy as measured by HbA1c, and number of hypoglycaemic episodes in type-1 diabetes mellitus subject. All subjects will be on BID NPH intermediate acting insulin therapy. If subject is using long acting insulin (Glargine, Detemir, etc.), he/she must be switched to NPH intermediate acting insulin. If on insulin analogue (Novolog, Lispro, Aspart, Aphidra, Glulisine, or any other analogue available in the subject's geographical area), the subject must be switched to regular human insulin 3 times a day.

Overall Status Unknown status
Start Date April 2008
Completion Date September 2011
Primary Completion Date August 2011
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
To compare the efficacy of Generex Oral-lyn™ RapidMist™ System and standard regular human insulin therapy as measured by HbA1c, in type-1 diabetes mellitus subjects on BID NPH intermediate acting insulin therapy change in HbA1c from the Day 0 (V3) to Day 180 (V9) of Treatment Phase.
Secondary Outcome
Measure Time Frame
To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System 26 week
Enrollment 500
Condition
Intervention

Intervention type: Drug

Intervention name: Generex Oral-lyn™

Description: 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

Arm group label: 1

Other name: buccal Insulin spray

Intervention type: Drug

Intervention name: Regular human insulin

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

Arm group label: 2

Other name: insulin

Eligibility

Criteria:

Inclusion Criteria:

- Be male or female between the ages 18 to 75 years

- Type 1 diabetes mellitus patients (according to ADA and/or WHO classification) who have >1 year history of type 1 DM and are currently managed with daily insulin injections totalling 0.3 to 0.8 IU/kg of body weight;

- Current physical examination, vital signs and ECG at screening that reveals no clinically significant abnormalities;

- Have a body mass index (BMI) <27;

- 8.5% (inclusively)

- Willing and able to follow the American Diabetes Association diet guidelines for type 1 diabetes; be able to commit to perform home blood glucose monitoring and record values as well as hypoglycemic events

- Willing to give written informed consent prior to admission into the study.

Exclusion Criteria:

- Have a significant active asthma or suspected abnormalities of buccal mucosa; cardiovascular, cerebrovascular, hepatic, renal, gastrointestinal, hematological, or auto-immune disease (other than auto-immune thyroid disease); history of athopy or drugs allergy

- Have evidence of unstable retinopathy (defined as pre-proliferative or proliferative retinopathy currently requiring photocoagulation therapy), nephropathy or neuropathy (gastroparesis or orthostatic hypotension);

- Have hypoglycemia unawareness;

- Have had more than one episode of severe hypoglycemia with seizure or coma or ketoacidosis within the past 12 months;

- Have a blood pressure in excess of 160/100 mmHg at the Screening visit;

- Have had any acute illness within the 2 weeks prior to screening;

- Have a history of drug or alcohol abuse that in the opinion of the Investigator would interfere with participation in the protocol

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Location
facility
Coastal Biomedical Research Inc. at Santa Monica | 2001 Santa Monica Blvd Suite 390W, California, 90404, United States
The Center for Diabetes & Endocrine Care at Hollywood | 1150 N. 35th Ave Suite 590, Florida, 33021, United States
Physicians Research Group at Indianapolis | 7400 North Shadeland Ave, Indiana, United States
MODEL Clinical Research at Baltimore | 6535 North Charles Street Suite 400N, Maryland, 21204, United States
Grunberger Diabetes Institute at Bloomfield Hills | 43494 Woodward Ave Suite 208, Michigan, 48302, United States
Beth Israel Medical Center, Geral J. Friedman Diabetes Institute at New York | 317 East 17th Street Room 7F05 8th Floor, New York, 10003, United States
Multiple Health Research, LLC. at Arlington | 501 Rita Lane Suite 113, Texas, 76014, United States
University of Texas Southwestern Medical Center at Dallas | 5323 Harry Hines Blvd, Texas, 75390-8858, United States
University Multiprofile Hospital for Active Treatment "Aleksandrovska" | 1 St. Georgi Sofiysky St, Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment at Varna | 1 Hristo Smirnensky St, 9010, Bulgaria
Multiprofile Hospital for Active Treatment at Stara Zagora | 11 Armeyska St., 6003, Bulgaria
University Multiprofile Hospital for Active Treatment at Plovdiv | 15A Vassil Aprilov Blvd, 4002, Bulgaria
Multiprofile Hospital for Active Treatment at Ruse | 2 Nezavisimost St, 7002, Bulgaria
University Multiprofile Hospital for Active Treatment at Pleven | 8A Georgi Kotchev St, 5800, Bulgaria
The Bailey Clinic at Red Deer | #108 3947 50A Avenue, Alberta, T4N 6V7, Canada
Calgary Metabolic Education & Research Centre at Calgary | #23, 4411-16th Avenue NW, Alberta, T3B 0M3, Canada
West Edmonton Diabetes Centre | 10230 142 St Nw # 25, Edmonton, Alberta, T5N 3Y6, Canada
Instituto de Endocrinologia IEMYR | Avenida La Coruña Nº 6337 y San Ignacio, Quito, Ecuador
Bydgoszcz Diabetology and Endocrinology Center at Bydgoszcz | ul. Baczynskiego 17, 85 - 822, Poland
OSTEOMED Medical Center at Warszawa | ul. Bialobrzeska 40A, 02 - 341, Poland
Chair and Department of Internal Medicine and Diabetology, Voivodship Brodnowski Hospital at Warszawa | ul. Kondratowicza 8, 03 - 242, Poland
Diabetology Clinic for Adults, NZOZ Elblag Diabetology Center | ul. Krolewiecka 146, 82 -300, Poland
TeMeD - Clinical Trials at Rzeszow | ul. Mazowiecka 56, 35-324, Poland
Provincial Centre of Diabetology and Metabolic Diseases, M.Pirogow Provincial Specialist Hospital at Lodz | ul. Nowa 30/32, 90-030, Poland
Silesia Osteoporosis Center at Katowice | ul. Opolska 11/3, 40-084, Poland
TeMeD - Clinical Trials at Nowy Targ | ul. Wojska Polskiego 14, 34-400, Poland
NZOZ Specialist Centre of Internal Medicine and Diabetology Malgorzata Arciszewska at Bialystok | ul. Zamenhofa 10/20, 15 - 435, Poland
Celis Aguilera 10B | Fajardo, 00738, Puerto Rico
Puerto Medical Center | San Juan, 364246, Puerto Rico
Clinical Research, Puerto Rico | San Juan, Puerto Rico
"Nicolae Malaxa" Clinical Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Bucharest | 12 Vergului St Sector 2, 022441, Romania
Timisoara Emergency Clinical County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases at Timisoara | 156 Iosif Bulbuca Av, 300736, Romania
Satu Mare County Hospital, Department of Diabetology and Nutrition Diseases at Satu Mare | 2-3 Eroii Revolutiei Square, 440055, Romania
Private Practice at Galati | 25 Constructorilor St, Bl. E5/64, 800371, Romania
Cluj Emergency Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Cluj-Napoca | 3-5 Clinicilor St, 400006, Romania
Oradea Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Oradea | 33 Republicii St, 410032, Romania
National Institute of Diabetes, Nutrition and Metabolic Diseases, 1st Clinical Department of Diabetes, Nutrition and Metabolic Diseases at Bucharest | 5-7 Ion Movila St Sector 2, 020475, Romania
Cardiology Private Practice at Bala Mare | 6/72 Independentei St, 430123, Romania
Private Practice Nicodiab SRL at Bucharest | 92 Polona St, Bl 17 A+B, Sc. 1, Ap. 2, 010507, Romania
Municipal Medical Institution: City Hospital # 2, Municipal Diabetology and Rehabilitation Center | 1 3rd -Transportnaya str., Omsk, 644021, Russian Federation
St. Petersburg State Medical Institution: St. George Municipal Hospital | 1 Severny Pr., St.Petersburg, 194354, Russian Federation
Municipal Medical Institution: Medical Unit "Izhmash", Municipal Endocrinology Center | 1 Truda str., Izhevsk, 426067, Russian Federation
St. Petersburg State Medical Institution: Municipal Consulting and Diagnostic Center #1, St. Petersburg Territorial Diabetology Center | 10 Siqueirosa str., St. Petersburg, 194354, Russian Federation
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, 117036, Russian Federation
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, 117036, Russian Federation
St. Petersburg State Medical Institution: Municipal Hospital of St. Elizabeth | 14 Vavilovykh str., St. Petersburg, 195257, Russian Federation
State Medical Institution: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko | 190 Rodionova str., Nizhny Novgorod, 603126, Russian Federation
Medical Institution Municipal Clinical Hospital #67 | 2 "b" Salyama Adilya str., Moscow, 123423, Russian Federation
State Medical Institution: Kemerovo Regional Clinical Hospital | 22 Oktyabrsky Pr., Kemerovo, 650066, Russian Federation
State Medical Institution: Arkhangelsk Regional Clinical Hospital | 292 Lomonosova pr., Arkhangelsk, 163045, Russian Federation
State Medical Institution: Republican Hospital | 3 Pirogova str., Petrozavodsk, ,, 185019, Russian Federation
St. Petersburg State Medical Institution:Municipal Outpatient Clinic #51 | 33/35 Kosmonavtov Pr., St. Petersburg, 196211, Russian Federation
Moscow State Medical Institution Municipal Clinical Hospital #68 | 4 Shkuleva str., Moscow, 109263, Russian Federation
St. Petersburg State Medical Institution: City Aleksandrovskaya Hospital | 4 Solidarnosti Pr., St. Petersburg, 193312, Russian Federation
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, 194044, Russian Federation
St. Petersburg State Medical Institution: Municipal Multifield Hospital #2 | 5 Uchebny Per., St. Petersburg, 194354, Russian Federation
State Higher Educational Institution: Tyumen State Medical Academy under the Federal Agency for Healthcare and Social Development, Multifield Clinic | 54 Odesskaya str., Tyumen, 625023, Russian Federation
"Diabetes" Center Company Limited | 56 Sovetskoi Armii str., Samara, 443067, Russian Federation
State Medical Institution: Consulting and Diagnostic Center of Komi Republic, Diabetology Center | 6 Kuratova str., 167981, Syktyvkar, Russian Federation
State Medical Institution: Murmansk Regional Consulting and Diagnostic Center | 6 Pavlova str., Building 4, Murmansk, 183047, Russian Federation
Municipal Medical Institution: Municipal Clinical Hospital #1, Municipal Diabetology Center | 6 Zalesskogo str., Novosibirsk, 630047, Russian Federation
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., St. Petersburg, 197022, Russian Federation
State Institution: Moscow Regional Research Clinical Institute n.a. M.F.Vladimirsky | 61/2 Shchepkina str., Moscow, 129110, Russian Federation
State Higher Educational Institution: Ural State Medical Academy under the Federal Agency for Healthcare and Social Development; Family Medicine Clinic | 7 Kluchevskaya str., Ekaterinburg, 620219, Russian Federation
State Medical Healthcare Institution: Chelyabinsk Regional Clinical Hospital | 70 Vorovskogo str., Medgorodok, Chelyabinsk, 454076, Russian Federation
State Medical Institution:Territorial Endocrinology Center, Territorial Diabetology Center | 9 Artema str., Stavropol, 355045, Russian Federation
Regional Endocrinology Center, Diabetology Department at Lviv | 1, Ostrozskoho St., Lviv, 79010, Ukraine
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, 02175, Ukraine
M.V. Sklifosovskyi Regional Clinical Hospital, Endocrinology Department at Poltava | 23, Shevchenko St., 36024, Ukraine
City Clinical Hospital #9, Endocrinology Department at Dnipropetrovsk | 29, Vorontsova St., 49023, Ukraine
M.O. Semashko Republican Clinical Hospital, Endocrinology Department at Simferopol | 69 Kievskaya St., 95017, Ukraine
V.P. Komisarenko Institute for Endocrinology and Metabolism under the Ukrainian Academy of Medical Sciences, Clinical Diabetology Department at Kiev | 69, Vyshgorodskaya St., Kiev, 04114, Ukraine
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, 04114, Ukraine
V.Ya. Danylevskyi Institute for Endocrine Pathology under the Ukrainian Academy of Medical Sciences, Clinical Endocrinology Department at Kharkov | Pomerky 27, Kharkov, 61070, Ukraine
Location Countries

Bulgaria

Canada

Ecuador

Poland

Puerto Rico

Romania

Russian Federation

Ukraine

United States

Verification Date

June 2011

Responsible Party

Name title: George E. Markus

Organization: Generex Biotechnology Corp.

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 1

Arm group type: Experimental

Description: 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

Arm group label: 2

Arm group type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov