Active Comparator Study of Generex Oral-Lyn™ Spray and Injected Human Insulin - NCT00668850-33021 (Clinical Trial 218293)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy218293.aspx
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| City: |
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1150 N. 35th Ave Suite 590 |
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State:
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FL |
| Zip Code: |
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33021 |
| Conditions: |
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Diabetes Mellitus |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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The Center for Diabetes & Endocrine Care at Hollywood
1150 N. 35th Ave Suite 590, FL 33021
United States
Primary Contact:
Sam Lerman, MD
Email: samler@bellsouth.net
Phone: 954-963-7100
Secondary Contact:
Kirill Soldatov
Email: Kirill.Soldatov@psi-cro.com
Phone: 7-812-320-3855 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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