← Back to Search

Amylin Analog

Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus

Phase 3
Waitlist Available
Led By Alan Schorr, DO
Research Sponsored by Cheryl Rosenfeld, DO
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who do not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin®) 3 times daily with expected glucose control require higher than FDA approved dosage. The primary objective of the study is to determine whether higher doses of pramlintide (Symlin®) in patients with type 2 diabetes mellitus control glucose better than the FDA approved dose of 120 mcg three times daily. The secondary objectives include proving whether higher dose pramlintide (Symlin®) is more efficacious in causing weight loss and reduction in waist circumference than standard dose pramlintide (Symlin®),to determine whether blood levels of certain hormones correlate with need for higher dose therapy,and to determine whether or not the rate of common adverse effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg three times daily.

Eligible Conditions
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glucose control
Secondary study objectives
Weight loss
adverse effects
amylin level
+1 more

Side effects data

From 2022 Phase 4 trial • 22 Patients • NCT01841359
18%
Hypoglycemia
14%
Nausea
5%
Ethanol abuse / intoxication
5%
Auditory hallucinations
5%
Cold feeling behind eyes.
5%
Trembling
5%
Diarrhea (with urgency and incontinence)
5%
Increase in baseline anxiety.
5%
Symptoms of a urinary tract infection (UTI) (CVA tenderness w/ dysuria)
5%
Nightmares
5%
Hyperglycemia
5%
Elevated liver enzymes
5%
Altered taste (during treatment with study drug)
5%
Cholecystitis (prior to treatment with study drug)
5%
Sinus infection (Visit 4, following treatment with study drug)
5%
Weight loss (during study drug treatment)
5%
Dehydration (r/t diarrhea)
5%
Diarrhea (assoc. with dehydration requiring hospitalization)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pramlintide (Symlin)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Symlin Treated, Dose EscalationExperimental Treatment1 Intervention
pramlintide 360 mcg three times daily in patients previously treated with 120 mcg prior to the study.
Group II: Symlin Naive, Dose EscalationExperimental Treatment1 Intervention
Escalation of pramlintide dose to 360 mcg three times daily in patients not taking pramlintide prior to study.
Group III: Symlin Naive, Usual DoseActive Control1 Intervention
Symlin 120 mcg three times daily in patients not previously treated with pramlintide before the study.
Group IV: Symlin treated, Usual DoseActive Control1 Intervention
pramlintide 120 mcg three times daily in patients who have been treated with pramlintide 120 mcg prior to the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pramlintide
FDA approved

Find a Location

Who is running the clinical trial?

Amylin Pharmaceuticals, LLC.Industry Sponsor
40 Previous Clinical Trials
1,822 Total Patients Enrolled
5 Trials studying Diabetes
393 Patients Enrolled for Diabetes
Cheryl Rosenfeld, DOLead Sponsor
Alan Schorr, DOPrincipal InvestigatorSt. Mary Medical Center
Jeffrey Rothman, MDPrincipal InvestigatorUniversity Physicians Group Research
2 Previous Clinical Trials
305 Total Patients Enrolled
1 Trials studying Diabetes
35 Patients Enrolled for Diabetes
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top