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

NCT ID: NCT00668850

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-09-30

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Generex Oral-lyn™

Intervention Type: DRUG

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

2

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

Group Type: ACTIVE_COMPARATOR

Regular human insulin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Regular human insulin

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

Intervention Type: DRUG

Other Intervention Names

buccal Insulin spray; 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)<Have a glycosylated haemoglobulin HbA1c
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OSMOS Clinical Research, Inc

OTHER

Sponsor Role: collaborator

PSI Pharma Support Intl

UNKNOWN

Sponsor Role: collaborator

Nextrials, Inc.

INDUSTRY

Sponsor Role: collaborator

eResearch Technology, Inc.

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

ACM Pivotal Global Central Laboratory

INDUSTRY

Sponsor Role: collaborator

Generex Biotechnology Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Generex Biotechnology Corp.

Principal Investigators

Gerald Bernstein,, MD

Role: STUDY_CHAIR

Generex Biotechnology Corp.

Jaime Davidson, MD

Role: STUDY_DIRECTOR

Generex Biotechnology Corp.

Philip Raskin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Locations

Coastal Biomedical Research Inc. at Santa Monica

2001 Santa Monica Blvd Suite 390W, California, United States

The Center for Diabetes & Endocrine Care at Hollywood

1150 N. 35th Ave Suite 590, Florida, 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, United States

Grunberger Diabetes Institute at Bloomfield Hills

43494 Woodward Ave Suite 208, Michigan, United States

Beth Israel Medical Center, Geral J. Friedman Diabetes Institute at New York

317 East 17th Street Room 7F05 8th Floor, New York, United States

Multiple Health Research, LLC. at Arlington

501 Rita Lane Suite 113, Texas, United States

University of Texas Southwestern Medical Center at Dallas

5323 Harry Hines Blvd, Texas, United States

University Multiprofile Hospital for Active Treatment "Aleksandrovska"

1 Saint Georgi Sofiysky Saint, Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment at Varna

1 Hristo Smirnensky Saint, , Bulgaria

Multiprofile Hospital for Active Treatment at Stara Zagora

11 Armeyska Saint, , Bulgaria

University Multiprofile Hospital for Active Treatment at Plovdiv

15A Vassil Aprilov Blvd, , Bulgaria

Multiprofile Hospital for Active Treatment at Ruse

2 Nezavisimost Saint, , Bulgaria

University Multiprofile Hospital for Active Treatment at Pleven

8A Georgi Kotchev Saint, , Bulgaria

The Bailey Clinic at Red Deer

#108 3947 50A Avenue, Alberta, Canada

Calgary Metabolic Education & Research Centre at Calgary

#23, 4411-16th Avenue Northwest, Alberta, Canada

West Edmonton Diabetes Centre

10230 142 Saint Northwest # 25, Edmonton, Alberta, 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, , Poland

OSTEOMED Medical Center at Warszawa

Ul. Bialobrzeska 40A, , Poland

Chair and Department of Internal Medicine and Diabetology, Voivodship Brodnowski Hospital at Warszawa

Ul. Kondratowicza 8, , Poland

Diabetology Clinic for Adults, NZOZ Elblag Diabetology Center

Ul. Krolewiecka 146, , Poland

TeMeD - Clinical Trials at Rzeszow

Ul. Mazowiecka 56, , Poland

Provincial Centre of Diabetology and Metabolic Diseases, M.Pirogow Provincial Specialist Hospital at Lodz

Ul. Nowa 30/32, , Poland

Silesia Osteoporosis Center at Katowice

Ul. Opolska 11/3, , Poland

TeMeD - Clinical Trials at Nowy Targ

Ul. Wojska Polskiego 14, , Poland

NZOZ Specialist Centre of Internal Medicine and Diabetology Malgorzata Arciszewska at Bialystok

Ul. Zamenhofa 10/20, , Poland

Celis Aguilera 10B

Fajardo, , Puerto Rico

Puerto Medical Center

San Juan, , 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 Saint Sector 2, , Romania

Timisoara Emergency Clinical County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases at Timisoara

156 Iosif Bulbuca Av, , Romania

Satu Mare County Hospital, Department of Diabetology and Nutrition Diseases at Satu Mare

2-3 Eroii Revolutiei Square, , Romania

Private Practice at Galati

25 Constructorilor St, Bl. E5/64, , Romania

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

3-5 Clinicilor Saint, , Romania

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

33 Republicii Saint, , Romania

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, , Romania

Cardiology Private Practice at Bala Mare

6/72 Independentei Saint, , Romania

Private Practice Nicodiab SRL at Bucharest

92 Polona St, Bl 17 A+B, Sc. 1, Ap. 2, , Romania

Municipal Medical Institution: City Hospital # 2, Municipal Diabetology and Rehabilitation Center

1 3rd -Transportnaya Str., Omsk, , Russia

St. Petersburg State Medical Institution: St. George Municipal Hospital

1 Severny Pr., St.Petersburg, , Russia

Municipal Medical Institution: Medical Unit "Izhmash", Municipal Endocrinology Center

1 Truda Str., Izhevsk, , Russia

St. Petersburg State Medical Institution: Municipal Consulting and Diagnostic Center #1, St. Petersburg Territorial Diabetology Center

10 Siqueirosa Str., Saint Petersburg, , Russia

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, , Russia

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, , Russia

St. Petersburg State Medical Institution: Municipal Hospital of St. Elizabeth

14 Vavilovykh Str., Saint Petersburg, , Russia

State Medical Institution: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko

190 Rodionova Str., Nizhny Novgorod, , Russia

Medical Institution Municipal Clinical Hospital #67

2 "b" Salyama Adilya Str., Moscow, , Russia

State Medical Institution: Kemerovo Regional Clinical Hospital

22 Oktyabrsky Pr., Kemerovo, , Russia

State Medical Institution: Arkhangelsk Regional Clinical Hospital

292 Lomonosova Pr., Arkhangelsk, , Russia

State Medical Institution: Republican Hospital

3 Pirogova Str., Petrozavodsk, ,, , Russia

St. Petersburg State Medical Institution:Municipal Outpatient Clinic #51

33/35 Kosmonavtov Pr., Saint Petersburg, , Russia

Moscow State Medical Institution Municipal Clinical Hospital #68

4 Shkuleva Str., Moscow, , Russia

St. Petersburg State Medical Institution: City Aleksandrovskaya Hospital

4 Solidarnosti Pr., Saint Petersburg, , Russia

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, , Russia

St. Petersburg State Medical Institution: Municipal Multifield Hospital #2

5 Uchebny Per., Saint Petersburg, , Russia

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

54 Odesskaya Str., Tyumen, , Russia

"Diabetes" Center Company Limited

56 Sovetskoi Armii Str., Samara, , Russia

State Medical Institution: Consulting and Diagnostic Center of Komi Republic, Diabetology Center

6 Kuratova Str., 167981, , Russia

State Medical Institution: Murmansk Regional Consulting and Diagnostic Center

6 Pavlova Str., Building 4, Murmansk, , Russia

Municipal Medical Institution: Municipal Clinical Hospital #1, Municipal Diabetology Center

6 Zalesskogo Str., Novosibirsk, , Russia

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, , Russia

State Institution: Moscow Regional Research Clinical Institute n.a. M.F.Vladimirsky

61/2 Shchepkina Str., Moscow, , Russia

State Higher Educational Institution: Ural State Medical Academy under the Federal Agency for Healthcare and Social Development; Family Medicine Clinic

7 Kluchevskaya Str., Ekaterinburg, , Russia

State Medical Healthcare Institution: Chelyabinsk Regional Clinical Hospital

70 Vorovskogo Str., Medgorodok, Chelyabinsk, , Russia

State Medical Institution:Territorial Endocrinology Center, Territorial Diabetology Center

9 Artema Str., Stavropol, , Russia

Regional Endocrinology Center, Diabetology Department at Lviv

1, Ostrozskoho St., Lviv, , 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, , Ukraine

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

23, Shevchenko Saint, , Ukraine

City Clinical Hospital #9, Endocrinology Department at Dnipropetrovsk

29, Vorontsova Saint, , Ukraine

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

69 Kievskaya Saint, , 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, , 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, , Ukraine

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

Pomerky 27, Kharkov, , Ukraine

Countries

United States; Bulgaria; Canada; Ecuador; Poland; Puerto Rico; Romania; Russia; Ukraine

Other Identifiers

GEN-084-OL

Identifier Type: -

Identifier Source: org_study_id