Clinical Trial Details

Overview

Research Study Summary

A 32 week randomized study to demonstrate the superiority of an experimental drug vs Placebo measuring A1c, BMI, SPP, Bolus insulin dose in regards to baseline changes in Type 1 Diabetes patients

Purpose

A 32 week randomized study to demonstrate the superiority of an experimental drug vs Placebo measuring A1c,BMI, SPP, Bolus insulin dose in regards to baseline changes. This study is to evaluate the net clinical benefits of the experimental drug as an adjunct with Insulin therapy in Type 1 Diabetes patients

To Learn more

CW ID: 212740
Date Last Changed: January 25, 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:

  • Must be over 18yrs, Diabetes more than 1 year
  • HbA1c 7.0% to 11 .0% at screening
  • Must be treated with Insulin(s) or insulin analogs, MDI or CSII
  • BMI has to be greater than 18.5 kg/m2
  • Non-fast acting insulin dose is stable (±20%) for 2 weeks prior to Screening

Exclusion Criteria:

  • Use of any of medications for the treatment of diabetes except for Insulin, prior to 8 weeks of screening
  • Prior exposure to Sotagliflozin for any amount of time
  • No severe hypoglycemic events within 1 month of screening and no DKA within 6 months of screening
  • No major medical issues with Liver, Heart, Kidney
  • No known eating disorders

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

View Map

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.

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.