Type 2 Diabetes / Insulin Dependent, Phase 3

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

TX201720
  • All Genders

Study Summary

Out-Patient Clinic in Evansville, Indiana. NO overnight stays.

Interested participant must be able to make out-patient visits to the clinic.

Study drug: Sotagliflozin vs placebo.

Patients who have inadequate glycemic control on basal insulin alone or in addition to 2 stable oral anti-diabetes drugs for 8 weeks. All patients stay on current diabetes medication throughout the study.

Most all visits will be fasting and need to be in the morning.

Eligibility Criteria

Inclusion

Inclusion:

  • Ages 18 and older
  • HbA1c levels between 7.5-10.5%

**Exclusion: **

  • Type 1 DM
  • Not stable basal insulin for 8 weeks prior to screening
  • Rapid acting or sliding insulin, short acting insulin, inhaled insulin
  • Gastric Bypass
  • Weight loss medicine within 12 weeks or weight change of 5 kg or more
  • GLP1, SGLT2 inhibitor

Study Design

Study Start date:
Estimated Completion Date:

Study Description

12 clinic visits + 4 phone calls (almost all studies will be fasting ans scheduled in the mornings) Duration is 60 weeks Compensation up to approximately $950.00 + medical services and the study medication