Clinical Trial Details

Overview

Research Study Summary

A 52 week study to examine the efficacy, safety and tolerability trial of once daily, oral doses of an experimental drug as adjunctive to insulin therapy in patients with Type 1 Diabetes Mellitus

Purpose

A 52 week phase 3, randomized, double-blind, placebo-controlled, parallel-group, efficacy, safety and tolerability trial of once daily, oral doses of an experimental drug as adjunctive to insulin therapy over in patients with Type 1 Diabetes Mellitus.

To Learn more

CW ID: 212741
Date Last Changed: January 26, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Facility Type
N/A

Eligibility

Inclusion Criteria:

  • Adult patients 18 years and older with a diagnosis of type 1 diabetes for at least 1 year prior to informed consent
  • Being treated with insulin for at least 1 year
  • Insulin pump therapy of any insulin type, with at least 5 months experience prior to Visit 1, or MDI of at least 1 basal and 3 bolus injections daily
  • HbA1c must be 7.5% to 10.0% at screening

Exclusion Criteria:

  • Use of antidiabetic agent other than basal/bolus insulin within 3 months of screening
  • Occurrence of DKA within 3 months of screening requiring hospitalization
  • Severe hypoglycemia within 3 months of screening requiring hospitalization
  • Treatment with systemic corticosteroids or planned initiation of such therapy. Inhaled or topical use of corticosteroids is acceptable

Contact

Amy King, Clinical Research Coordinator
AMCR Institute, Inc.
625 West Citracado Parkway
Escondido, CA 92025
Phone: 1-877-567-2627
Fax: 760-466-1525

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Research Center Information:

AMCR Institute, Inc.

Volunteer for this Trial

If you would like to learn more about participating in this research study, please email the trial contact using the form below. We value your privacy and your information will only be used by the research center to contact you regarding this study.

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