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
San Antonio, Texas 78209
1189
mi
from 91732
San Antonio, TX
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Auburn, Maine 04210
2615
mi
from 91732
Auburn, ME
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Columbus, Ohio 43201
1960
mi
from 91732
Columbus, OH
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Concord, California 94520
353
mi
from 91732
Concord, CA
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Denver, Colorado 80209
818
mi
from 91732
Denver, CO
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Great Falls, Montana 59405
990
mi
from 91732
Great Falls, MT
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High Point, North Carolina 27265
2139
mi
from 91732
High Point, NC
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Jacksonville, Florida 32258
2138
mi
from 91732
Jacksonville, FL
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Manassas, Virginia 20110
2258
mi
from 91732
Manassas, VA
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Metairie, Louisiana 70006
1647
mi
from 91732
Metairie, LA
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Miami, Florida 33014
2322
mi
from 91732
Miami, FL
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Omaha, Nebraska 68114
1300
mi
from 91732
Omaha, NE
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Rockville, Maryland 20852
2275
mi
from 91732
Rockville, MD
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Salt Lake City, Utah 84107
570
mi
from 91732
Salt Lake City, UT
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Ventura, California 93003
70
mi
from 91732
Ventura, CA
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