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

Use our guide to learn which trials are right for you!

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
Jacksonville, Florida 32258
682
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
Auburn, Maine 04210
714
mi
from 43215
Auburn, ME
Click here to add this to my saved trials
Columbus, Ohio 43201
1
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
Concord, California 94520
2081
mi
from 43215
Concord, CA
Click here to add this to my saved trials
Denver, Colorado 80209
1161
mi
from 43215
Denver, CO
Click here to add this to my saved trials
Great Falls, Montana 59405
1494
mi
from 43215
Great Falls, MT
Click here to add this to my saved trials
High Point, North Carolina 27265
318
mi
from 43215
High Point, NC
Click here to add this to my saved trials
Manassas, Virginia 20110
307
mi
from 43215
Manassas, VA
Click here to add this to my saved trials
Metairie, Louisiana 70006
795
mi
from 43215
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33014
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
Omaha, Nebraska 68114
682
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
Rockville, Maryland 20852
320
mi
from 43215
Rockville, MD
Click here to add this to my saved trials
Salt Lake City, Utah 84107
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78209
1133
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
Ventura, California 93003
2017
mi
from 43215
Ventura, CA
Click here to add this to my saved trials