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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Generex Biotechnology Corp..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
OSMOS Clinical Research, Inc
PSI Pharma Support Intl
Nextrials, Inc.
eResearch Technology, Inc.
Hoffmann-La Roche
ACM Pivotal Global Central Laboratory
Information provided by:
Generex Biotechnology Corp.
ClinicalTrials.gov Identifier:
NCT00668850
First received: April 24, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: Generex Oral-lyn™
Drug: Regular human insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Generex Biotechnology Corp.:

Primary Outcome Measures:
  • 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 [ Time Frame: change in HbA1c from the Day 0 (V3) to Day 180 (V9) of Treatment Phase. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety, tolerability, and satisfaction with Generex Oral-lyn™ therapy when administered by the RapidMist™ Diabetes Management System [ Time Frame: 26 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: April 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Other Name: buccal Insulin spray
Active Comparator: 2
Regular human insulin 30 minutes before meals + 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.
Other Name: insulin

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668850

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

No publications provided

Responsible Party: George E. Markus, Generex Biotechnology Corp.
ClinicalTrials.gov Identifier: NCT00668850     History of Changes
Other Study ID Numbers: GEN-084-OL
Study First Received: April 24, 2008
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014