Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amylin Pharmaceuticals, LLC. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss.
The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exenatide 5 mcg | Experimental | exenatide 5 mcg |
|
| exenatide 10 mcg | Experimental | exenatide 10 mcg |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide 5 mcg | Drug | exenatide 5 mcg |
| |
| exenatide 10 mcg |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Insulin | To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients. | after 24 hours fast at baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | To compare the body weight at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients | value at 12 weeks minus value at baseline |
| HbA1c |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paresh Dandona, MBBS | SUNY at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Millard Fillmore Gates Hospital | Buffalo | New York | 14209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29346597 | Derived | Dandona P, Ghanim H, Abuaysheh S, Green K, Dhindsa S, Makdissi A, Batra M, Kuhadiya ND, Chaudhuri A. Exenatide Increases IL-1RA Concentration and Induces Nrf-2-Keap-1-Regulated Antioxidant Enzymes: Relevance to beta-Cell Function. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1180-1187. doi: 10.1210/jc.2017-02343. |
Not provided
Not provided
The exenatide 10mcg group started on 5mcg for a single dose study (samples collected were at 0, 2, 4, and 6 hours)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide | Period 1 = 5 mcg Period 2 = 10 mcg |
| FG001 | Placebo | placebo placebo: saline sq |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exenatide 5 mcg |
| |||||||||||||
| Exenatide 10 mcg |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide 10 mcg | exenatide 5mcg and then exenatide 10 mcg |
| BG001 | Placebo | placebo placebo: saline sq |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fasting Insulin | To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients. | Posted | Mean | Standard Error | μU/mL | after 24 hours fast at baseline and 12 weeks |
|
Not provided
participants were monitored/assessed for possible adverse events, but none occurred
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exenatide 5mcg Then Exenatide 10 mcg | given exenatide 5mcg followed by exenatide 10mcg |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paresh Dandona | State University of NY at Buffalo | 7165351850 | dandona@buffalo.edu |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
exenatide 10 mcg |
|
| placebo | Drug | saline sq |
|
To compare the HbA1c at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients. |
| value at 12 weeks minus value at baseline |
| Intranuclear NFκB Binding Activity | Measured by a gel shift assay showing the NFKB and Oct-1 binding to the doublestranded oligonucleotide containing the NFKB DNA binding site in Exenatide group and placebo group | measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline |
| NOT COMPLETED |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Data was not collected | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m² |
|
| HbA1c | Mean | Standard Deviation | % |
|
| Fasting Blood Glucose | Mean | Standard Deviation | mg/dl |
|
| FFA | Mean | Standard Deviation | mM |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Weight | To compare the body weight at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients | Posted | Mean | Standard Error | lbs | value at 12 weeks minus value at baseline |
|
|
|
| Secondary | HbA1c | To compare the HbA1c at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients. | Posted | Mean | Standard Error | percent | value at 12 weeks minus value at baseline |
|
|
|
| Secondary | Intranuclear NFκB Binding Activity | Measured by a gel shift assay showing the NFKB and Oct-1 binding to the doublestranded oligonucleotide containing the NFKB DNA binding site in Exenatide group and placebo group | Posted | Mean | Standard Error | % ratio of NFKB/Oct-1 | measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo | placebo placebo: saline sq | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |