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Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia

NCT01269047 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-04-12

Study results available
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Summary

The main purpose of the study is to determine the effects of 16 weeks of adjunctive pramlintide or exenatide use on glycemic control in Type 1 Diabetes.

Conditions

Interventions

DRUG

Pramlintide

Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months

DRUG

Exenatide

Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months

DRUG

Insulin

Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Rubina A Heptulla, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01269047 on ClinicalTrials.gov