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Amylin Analog

Symlin Treated, Dose Escalation for Type 2 Diabetes

Phase 3
Waitlist Available
Led By Jeffrey Rothman, MD
Research Sponsored by Cheryl Rosenfeld, DO
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80 years.
Type 2 diabetes mellitus.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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
  • Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glucose control
Secondary outcome measures
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%
Cold feeling behind eyes.
5%
Trembling
5%
Diarrhea (with urgency and incontinence)
5%
Auditory hallucinations
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)

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
2,025 Total Patients Enrolled
Cheryl Rosenfeld, DOLead Sponsor
Jeffrey Rothman, MDPrincipal InvestigatorUniversity Physicians Group Research
2 Previous Clinical Trials
305 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025