Clinical Trials Logo
  1. Home
  2. Type 2 Diabetes Mellitus
  3. NCT00948493
  4. Details
NCT00948493 Clinical Trial

Treatment Use of Generex Oral-lyn™ in Patients With Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:
An Open-Label Treatment Investigational New Drug (IND) for the Use of Generex Oral-lyn™ in Patients With Type 1 or Type 2 Diabetes Mellitus

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00948493
Other study ID # GEN-100-OL
Secondary ID
Status No longer available
Phase N/A
First received July 27, 2009
Last updated March 18, 2013

Study information
Verified date March 2013
Source Generex Biotechnology Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial Summary

The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Study is closed

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Buccal insulin spray
Oral insulin spray absorbed in buccal mucosa

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Generex Biotechnology Corp.
See also
  Status Clinical Trial Phase
Completed NCT02771093 - An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus Phase 4
Completed NCT02545842 - Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL) Phase 4
Recruiting NCT03436212 - Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. N/A
Completed NCT03244800 - A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus. Phase 2
Completed NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Withdrawn NCT02769091 - A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes Phase 2
Recruiting NCT06065540 - A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor Phase 3
Recruiting NCT05008276 - Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
Completed NCT04091373 - A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide Phase 1
Completed NCT03296800 - Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects Phase 1
Recruiting NCT06212778 - Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
Completed NCT05979519 - Fresh Carts for Mom's to Improve Food Security and Glucose Management N/A
Recruiting NCT05579314 - XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Terminated NCT03684642 - Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Phase 3
Completed NCT03248401 - Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes Phase 4
Completed NCT03644134 - A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns N/A
Completed NCT05295160 - Fasting-Associated Immune-metabolic Remission of Diabetes N/A
Completed NCT02836873 - Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment Phase 3
Completed NCT02252224 - Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance