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

NCT01137695 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-10-14

No results posted yet for this 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.

Conditions

Interventions

DRUG

Pramlintide

120 mcg SQ three times daily for 6 months.

DRUG

Pramlintide

360 mcg SQ three times daily for 6 months

DRUG

Pramlintide

120 mcg SQ three times daily for 6 months

DRUG

Pramlintide

360 mcg SQ three times daily for 6 months

Sponsors & Collaborators

  • Amylin Pharmaceuticals, LLC.

    collaborator INDUSTRY

  • Cheryl Rosenfeld, DO

    lead OTHER

Principal Investigators

  • Cheryl Rosenfeld, DO · North Jersey Endocrine Consultants

  • Jeffrey Rothman, MD · University Physicians Group Research

  • Alan Schorr, DO · St. Mary's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-01-31
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137695 on ClinicalTrials.gov