Dose-ranging Study in Patients With Type 1 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:12/27/2017
Start Date:July 2015
End Date:August 2016

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A Phase 2b, Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study in Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

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


Inclusion Criteria:

- Patient has given written informed consent to participate in the study in accordance
with local regulations

- Adult patients 18 years and older with a diagnosis of T1D made at least 1 year prior
to informed consent

- Patients are being treated with insulin or insulin analog delivered via CSII or MDI

- At the Screening Visit, A1C must be between 7.0% to 10.0%

- Females of childbearing potential must use an adequate method of contraception and
have a negative pregnancy test

Exclusion Criteria:

- 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
We found this trial at
15
sites
Omaha, Nebraska 68114
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Omaha, NE
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Auburn, Maine 04210
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Auburn, ME
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Columbus, Ohio 43201
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Columbus, OH
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Concord, California 94520
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Concord, CA
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Denver, Colorado 80209
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Denver, CO
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Great Falls, Montana 59405
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Great Falls, MT
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High Point, North Carolina 27265
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High Point, NC
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Jacksonville, Florida 32258
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Jacksonville, FL
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Manassas, Virginia 20110
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Manassas, VA
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Metairie, Louisiana 70006
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Metairie, LA
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Miami, Florida 33014
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Miami, FL
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Rockville, Maryland 20852
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Rockville, MD
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Salt Lake City, Utah 84107
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Salt Lake City, UT
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San Antonio, Texas 78209
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San Antonio, TX
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Ventura, California 93003
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Ventura, CA
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