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Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus

NCT02500979 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-11-02

Study results available
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Summary

This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Pramlintide acetate

Pramlintide acetate administered by a separate pump

DRUG

Placebo

Placebo administered by separate pump

DRUG

Lispro insulin U-100

Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5)

DRUG

Regular insulin U-100

Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Peter Ohman, MD · Medical Director AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-08-17
Primary Completion
2016-08-05
Completion
2016-08-05

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02500979 on ClinicalTrials.gov