Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.

Key facts

Study ID

NCT02459899

Run by

Lexicon Pharmaceuticals

People needed

141

Starts

2015-07-01

Expected to finish

2016-08-01

Last updated by the study team

2020-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant had given written informed consent to participate in the study in accordance with local regulations.
• Adult participants 18 years and older with a diagnosis of type 1 diabetes mellitus (T1D) made at least 1 year prior to informed consent.
• Participants were being treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).
• At the Screening Visit, A1C had to be between 7.0% and 10.0%.
• Females of childbearing potential had to use an adequate method of contraception and have a negative pregnancy test.

You may not qualify if…

• Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
• Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
• Chronic systemic corticosteroid use.
• Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.

Where it is running

• Lexicon Investigational Site — Concord, California, United States
• Lexicon Investigational Site — Ventura, California, United States
• Lexicon Investigational Site — Denver, Colorado, United States
• Lexicon Investigational Site — Jacksonville, Florida, United States
• Lexicon Investigational Site — Miami, Florida, United States
• Lexicon Investigational Site — Springfield, Illinois, United States
• Lexicon Investigational Site — Metairie, Louisiana, United States
• Lexicon Investigational Site — Auburn, Maine, United States
• Lexicon Investigational Site — Rockville, Maryland, United States
• Lexicon Investigational Site — Great Falls, Montana, United States
• Lexicon Investigational Site — Omaha, Nebraska, United States
• Lexicon Investigational Site — High Point, North Carolina, United States
• Lexicon Investigational Site — Columbus, Ohio, United States
• Lexicon Investigational Site — San Antonio, Texas, United States
• Lexicon Investigational Site — Salt Lake City, Utah, United States
• Lexicon Investigational Site — Chesapeake, Virginia, United States
• Lexicon Investigational Site — Manassas, Virginia, United States

Full record on ClinicalTrials.gov

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