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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00668850
• Other study ID #: GEN-084-OL
• Status: Unknown status
• Phase: Phase 3
• First received: April 24, 2008
• Last updated: June 6, 2011
• Start date: April 2008
• Est. completion date: September 2011

Study information

• Verified date: June 2011
• Source: Generex Biotechnology Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 500
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Bulgaria	University Multiprofile Hospital for Active Treatment at Varna	1 Hristo Smirnensky St
Bulgaria	University Multiprofile Hospital for Active Treatment "Aleksandrovska"	1 St. Georgi Sofiysky St	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment at Stara Zagora	11 Armeyska St.
Bulgaria	University Multiprofile Hospital for Active Treatment at Plovdiv	15A Vassil Aprilov Blvd
Bulgaria	Multiprofile Hospital for Active Treatment at Ruse	2 Nezavisimost St
Bulgaria	University Multiprofile Hospital for Active Treatment at Pleven	8A Georgi Kotchev St
Canada	The Bailey Clinic at Red Deer	#108 3947 50A Avenue	Alberta
Canada	Calgary Metabolic Education & Research Centre at Calgary	#23, 4411-16th Avenue NW	Alberta
Canada	West Edmonton Diabetes Centre	10230 142 St Nw # 25, Edmonton	Alberta
Ecuador	Instituto de Endocrinologia IEMYR	Avenida La Coruña Nº 6337 y San Ignacio	Quito
Poland	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
Puerto Rico	Celis Aguilera 10B	Fajardo
Puerto Rico	Clinical Research, Puerto Rico	San Juan
Puerto Rico	Puerto Medical Center	San Juan
Romania	"Nicolae Malaxa" Clinical Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Bucharest	12 Vergului St 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 St
Romania	Oradea Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases at Oradea	33 Republicii St
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
Romania	Cardiology Private Practice at Bala Mare	6/72 Independentei St
Romania	Private Practice Nicodiab SRL at Bucharest	92 Polona St, Bl 17 A+B, Sc. 1, Ap. 2
Russian Federation	Municipal Medical Institution: City Hospital # 2, Municipal Diabetology and Rehabilitation Center	1 3rd -Transportnaya str., Omsk
Russian Federation	St. Petersburg State Medical Institution: St. George Municipal Hospital	1 Severny Pr., St.Petersburg
Russian Federation	Municipal Medical Institution: Medical Unit "Izhmash", Municipal Endocrinology Center	1 Truda str., Izhevsk
Russian Federation	St. Petersburg State Medical Institution: Municipal Consulting and Diagnostic Center #1, St. Petersburg Territorial Diabetology Center	10 Siqueirosa str., St. Petersburg
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
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
Russian Federation	St. Petersburg State Medical Institution: Municipal Hospital of St. Elizabeth	14 Vavilovykh str., St. Petersburg
Russian Federation	State Medical Institution: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko	190 Rodionova str., Nizhny Novgorod
Russian Federation	Medical Institution Municipal Clinical Hospital #67	2 "b" Salyama Adilya str., Moscow
Russian Federation	State Medical Institution: Kemerovo Regional Clinical Hospital	22 Oktyabrsky Pr., Kemerovo
Russian Federation	State Medical Institution: Arkhangelsk Regional Clinical Hospital	292 Lomonosova pr., Arkhangelsk
Russian Federation	State Medical Institution: Republican Hospital	3 Pirogova str., Petrozavodsk, ,
Russian Federation	St. Petersburg State Medical Institution:Municipal Outpatient Clinic #51	33/35 Kosmonavtov Pr., St. Petersburg
Russian Federation	Moscow State Medical Institution Municipal Clinical Hospital #68	4 Shkuleva str., Moscow
Russian Federation	St. Petersburg State Medical Institution: City Aleksandrovskaya Hospital	4 Solidarnosti Pr., St. Petersburg
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
Russian Federation	St. Petersburg State Medical Institution: Municipal Multifield Hospital #2	5 Uchebny Per., St. Petersburg
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
Russian Federation	"Diabetes" Center Company Limited	56 Sovetskoi Armii str., Samara
Russian Federation	State Medical Institution: Consulting and Diagnostic Center of Komi Republic, Diabetology Center	6 Kuratova str., 167981
Russian Federation	State Medical Institution: Murmansk Regional Consulting and Diagnostic Center	6 Pavlova str., Building 4, Murmansk
Russian Federation	Municipal Medical Institution: Municipal Clinical Hospital #1, Municipal Diabetology Center	6 Zalesskogo str., Novosibirsk
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
Russian Federation	State Institution: Moscow Regional Research Clinical Institute n.a. M.F.Vladimirsky	61/2 Shchepkina str., Moscow
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
Russian Federation	State Medical Healthcare Institution: Chelyabinsk Regional Clinical Hospital	70 Vorovskogo str., Medgorodok, Chelyabinsk
Russian Federation	State Medical Institution:Territorial Endocrinology Center, Territorial Diabetology Center	9 Artema str., Stavropol
Ukraine	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 St.
Ukraine	City Clinical Hospital #9, Endocrinology Department at Dnipropetrovsk	29, Vorontsova St.
Ukraine	M.O. Semashko Republican Clinical Hospital, Endocrinology Department at Simferopol	69 Kievskaya St.
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
United States	The Center for Diabetes & Endocrine Care at Hollywood	1150 N. 35th Ave Suite 590	Florida
United States	Coastal Biomedical Research Inc. at Santa Monica	2001 Santa Monica Blvd Suite 390W	California
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	Grunberger Diabetes Institute at Bloomfield Hills	43494 Woodward Ave Suite 208	Michigan
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	MODEL Clinical Research at Baltimore	6535 North Charles Street Suite 400N	Maryland
United States	Physicians Research Group at Indianapolis	7400 North Shadeland Ave	Indiana

Sponsors (7)

Lead Sponsor	Collaborator
Generex Biotechnology Corp.	ACM Pivotal Global Central Laboratory, eResearch Technology, Inc., Hoffmann-La Roche, Nextrials, Inc., OSMOS Clinical Research, Inc, PSI Pharma Support Intl

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Ecuador,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System		26 week