Clinical trial NCT00668850: Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Generex Biotechnology Corp.
Sponsor class: INDUSTRY
Collaborators: name: OSMOS Clinical Research, Inc
name: PSI Pharma Support Intl
name: Nextrials, Inc.
name: eResearch Technology, Inc.
name: Hoffmann-La Roche
name: ACM Pivotal Global Central Laboratory
First posted: 2008-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: change in HbA1c from the Day 0 (V3) to Day 180 (V9) of Treatment Phase.
Secondary outcomes:
measure: To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System
timeFrame: 26 week
Other outcomes:
Locations:
city: 2001 Santa Monica Blvd Suite 390W
country: United States
facility: Coastal Biomedical Research Inc. at Santa Monica
state: California
city: 1150 N. 35th Ave Suite 590
country: United States
facility: The Center for Diabetes & Endocrine Care at Hollywood
state: Florida
city: 7400 North Shadeland Ave
country: United States
facility: Physicians Research Group at Indianapolis
state: Indiana
city: 6535 North Charles Street Suite 400N
country: United States
facility: MODEL Clinical Research at Baltimore
state: Maryland
city: 43494 Woodward Ave Suite 208
country: United States
facility: Grunberger Diabetes Institute at Bloomfield Hills
state: Michigan
city: 317 East 17th Street Room 7F05 8th Floor
country: United States
facility: Beth Israel Medical Center, Geral J. Friedman Diabetes Institute at New York
state: New York
city: 501 Rita Lane Suite 113
country: United States
facility: Multiple Health Research, LLC. at Arlington
state: Texas
city: 5323 Harry Hines Blvd
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: 1 St. Georgi Sofiysky St
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Aleksandrovska"
state: Sofia
city: 1 Hristo Smirnensky St
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment at Varna
city: 11 Armeyska St.
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment at Stara Zagora
city: 15A Vassil Aprilov Blvd
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment at Plovdiv
city: 2 Nezavisimost St
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment at Ruse
city: 8A Georgi Kotchev St
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment at Pleven
city: #108 3947 50A Avenue
country: Canada
facility: The Bailey Clinic at Red Deer
state: Alberta
city: #23, 4411-16th Avenue NW
country: Canada
facility: Calgary Metabolic Education & Research Centre at Calgary
state: Alberta
city: 10230 142 St Nw # 25, Edmonton
country: Canada
facility: West Edmonton Diabetes Centre
state: Alberta
city: Avenida La Coruña Nº 6337 y San Ignacio
country: Ecuador
facility: Instituto de Endocrinologia IEMYR
state: Quito
city: ul. Baczynskiego 17
country: Poland
facility: Bydgoszcz Diabetology and Endocrinology Center at Bydgoszcz
city: ul. Bialobrzeska 40A
country: Poland
facility: OSTEOMED Medical Center at Warszawa
city: ul. Kondratowicza 8
country: Poland
facility: Chair and Department of Internal Medicine and Diabetology, Voivodship Brodnowski Hospital at Warszawa
city: ul. Krolewiecka 146
country: Poland
facility: Diabetology Clinic for Adults, NZOZ Elblag Diabetology Center
city: ul. Mazowiecka 56
country: Poland
facility: TeMeD - Clinical Trials at Rzeszow
city: ul. Nowa 30/32
country: Poland
facility: Provincial Centre of Diabetology and Metabolic Diseases, M.Pirogow Provincial Specialist Hospital at Lodz
city: ul. Opolska 11/3
country: Poland
facility: Silesia Osteoporosis Center at Katowice
city: ul. Wojska Polskiego 14
country: Poland
facility: TeMeD - Clinical Trials at Nowy Targ
city: ul. Zamenhofa 10/20
country: Poland
facility: NZOZ Specialist Centre of Internal Medicine and Diabetology Malgorzata Arciszewska at Bialystok
city: Fajardo
country: Puerto Rico
facility: Celis Aguilera 10B
city: San Juan
country: Puerto Rico
facility: Puerto Medical Center
city: San Juan
country: Puerto Rico
facility: Clinical Research, Puerto Rico
city: 12 Vergului St Sector 2
country: Romania
facility: "Nicolae Malaxa" Clinical Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Bucharest
city: 156 Iosif Bulbuca Av
country: Romania
facility: Timisoara Emergency Clinical County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases at Timisoara
city: 2-3 Eroii Revolutiei Square
country: Romania
facility: Satu Mare County Hospital, Department of Diabetology and Nutrition Diseases at Satu Mare
city: 25 Constructorilor St, Bl. E5/64
country: Romania
facility: Private Practice at Galati
city: 3-5 Clinicilor St
country: Romania
facility: Cluj Emergency Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Cluj-Napoca
city: 33 Republicii St
country: Romania
facility: Oradea Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Oradea
city: 5-7 Ion Movila St Sector 2
country: Romania
facility: National Institute of Diabetes, Nutrition and Metabolic Diseases, 1st Clinical Department of Diabetes, Nutrition and Metabolic Diseases at Bucharest
city: 6/72 Independentei St
country: Romania
facility: Cardiology Private Practice at Bala Mare
city: 92 Polona St, Bl 17 A+B, Sc. 1, Ap. 2
country: Romania
facility: Private Practice Nicodiab SRL at Bucharest
city: 1 3rd -Transportnaya str., Omsk
country: Russian Federation
facility: Municipal Medical Institution: City Hospital # 2, Municipal Diabetology and Rehabilitation Center
city: 1 Severny Pr., St.Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution: St. George Municipal Hospital
city: 1 Truda str., Izhevsk
country: Russian Federation
facility: Municipal Medical Institution: Medical Unit "Izhmash", Municipal Endocrinology Center
city: 10 Siqueirosa str., St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution: Municipal Consulting and Diagnostic Center #1, St. Petersburg Territorial Diabetology Center
city: 11 Dmitriya Ulyanova str., Moscow
country: Russian Federation
facility: 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
city: 11 Dmitriya Ulyanova str., Moscow
country: Russian Federation
facility: 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
city: 14 Vavilovykh str., St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution: Municipal Hospital of St. Elizabeth
city: 190 Rodionova str., Nizhny Novgorod
country: Russian Federation
facility: State Medical Institution: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
city: 2 "b" Salyama Adilya str., Moscow
country: Russian Federation
facility: Medical Institution Municipal Clinical Hospital #67
city: 22 Oktyabrsky Pr., Kemerovo
country: Russian Federation
facility: State Medical Institution: Kemerovo Regional Clinical Hospital
city: 292 Lomonosova pr., Arkhangelsk
country: Russian Federation
facility: State Medical Institution: Arkhangelsk Regional Clinical Hospital
city: 3 Pirogova str., Petrozavodsk, ,
country: Russian Federation
facility: State Medical Institution: Republican Hospital
city: 33/35 Kosmonavtov Pr., St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution:Municipal Outpatient Clinic #51
city: 4 Shkuleva str., Moscow
country: Russian Federation
facility: Moscow State Medical Institution Municipal Clinical Hospital #68
city: 4 Solidarnosti Pr., St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution: City Aleksandrovskaya Hospital
city: 4/2 Lebedeva str., St.Petersburg
country: Russian Federation
facility: Federal State Medical Institution: All-Russia Center for Urgent Care and Radiation Medicine n.a. A.M. Nikiforov under the Russian Emergency Control Ministry
city: 5 Uchebny Per., St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution: Municipal Multifield Hospital #2
city: 54 Odesskaya str., Tyumen
country: Russian Federation
facility: State Higher Educational Institution: Tyumen State Medical Academy under the Federal Agency for Healthcare and Social Development, Multifield Clinic
city: 56 Sovetskoi Armii str., Samara
country: Russian Federation
facility: "Diabetes" Center Company Limited
city: 6 Kuratova str., 167981
country: Russian Federation
facility: State Medical Institution: Consulting and Diagnostic Center of Komi Republic, Diabetology Center
city: 6 Pavlova str., Building 4, Murmansk
country: Russian Federation
facility: State Medical Institution: Murmansk Regional Consulting and Diagnostic Center
city: 6 Zalesskogo str., Novosibirsk
country: Russian Federation
facility: Municipal Medical Institution: Municipal Clinical Hospital #1, Municipal Diabetology Center
city: 6/8 L. Tolstogo str., St. Petersburg
country: Russian Federation
facility: State Higher Educational Institution: St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development
city: 61/2 Shchepkina str., Moscow
country: Russian Federation
facility: State Institution: Moscow Regional Research Clinical Institute n.a. M.F.Vladimirsky
city: 7 Kluchevskaya str., Ekaterinburg
country: Russian Federation
facility: State Higher Educational Institution: Ural State Medical Academy under the Federal Agency for Healthcare and Social Development; Family Medicine Clinic
city: 70 Vorovskogo str., Medgorodok, Chelyabinsk
country: Russian Federation
facility: State Medical Healthcare Institution: Chelyabinsk Regional Clinical Hospital
city: 9 Artema str., Stavropol
country: Russian Federation
facility: State Medical Institution:Territorial Endocrinology Center, Territorial Diabetology Center
city: 1, Ostrozskoho St., Lviv
country: Ukraine
facility: Regional Endocrinology Center, Diabetology Department at Lviv
city: 121, Kharkovskoe Shosse, Kiev
country: Ukraine
facility: 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
city: 23, Shevchenko St.
country: Ukraine
facility: M.V. Sklifosovskyi Regional Clinical Hospital, Endocrinology Department at Poltava
city: 29, Vorontsova St.
country: Ukraine
facility: City Clinical Hospital #9, Endocrinology Department at Dnipropetrovsk
city: 69 Kievskaya St.
country: Ukraine
facility: M.O. Semashko Republican Clinical Hospital, Endocrinology Department at Simferopol
city: 69, Vyshgorodskaya St., Kiev
country: Ukraine
facility: V.P. Komisarenko Institute for Endocrinology and Metabolism under the Ukrainian Academy of Medical Sciences, Clinical Diabetology Department at Kiev
city: 69, Vyshgorodskaya St., Kiev
country: Ukraine
facility: V.P. Komisarenko Institute for Endocrinology and Metabolism under the Ukrainian Academy of Medical Sciences, General Endocrine Pathology Department at Kiev
city: Pomerky 27, Kharkov
country: Ukraine
facility: V.Ya. Danylevskyi Institute for Endocrine Pathology under the Ukrainian Academy of Medical Sciences, Clinical Endocrinology Department at Kharkov
Study officials:
affiliation: Generex Biotechnology Corp.
name: Gerald Bernstein,, MD
role: STUDY_CHAIR
affiliation: Generex Biotechnology Corp.
name: Jaime Davidson, MD
role: STUDY_DIRECTOR
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Philip Raskin, MD
role: PRINCIPAL_INVESTIGATOR
References: