| Trial ID: | L6061 |
| Source ID: | NCT01137695
|
| Associated Drug: |
Pramlintide
|
| Title: |
Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Pramlintide|DRUG: Pramlintide|DRUG: Pramlintide|DRUG: Pramlintide
|
| Outcome Measures: |
Primary: Glucose control, A1c Fasting plasma glucose Post-prandial glucose Glycomark, 6 months | Secondary: Weight loss, Weight, BMI, Waist circumference., 6 months|amylin level, does initial blood amylin level correlate with need for higher dose pramlintide?, initial|glucagon level, Does change in glucagon level correlate with glycemic response., 6 months|adverse effects, Whether or not the rate of common adverse effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg TID (as compared to the clinical practice study) - GI: nausea 30% and Hypoglycemia: medically assisted 0.7% or patient ascertained 0.7%., 6 months
|
| Sponsor/Collaborators: |
Sponsor: Cheryl Rosenfeld, DO | Collaborators: Amylin Pharmaceuticals, LLC.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-05
|
| Completion Date: |
2012-04
|
| Results First Posted: |
|
| Last Update Posted: |
2011-10-14
|
| Locations: |
North Jersey Endocrine Consultants, Denville, New Jersey, 07834, United States|University Physicians Group, Staten Island, New York, 10301, United States|St. Mary Medical Center, Langhorne, Pennsylvania, 19047, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01137695
|
