Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2010
End Date:November 2010

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

A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)

This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical
trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin
glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or
with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified
treatment.


Inclusion Criteria:

- Insulin naïve subject (allowed are: previous short term insulin treatment up to 14
days; Treatment during hospitalisation or during gestational diabetes is allowed for
periods longer than 14 days)

- Current treatment: metformin monotherapy or metformin in any combination with insulin
secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor,
alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three
months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in
combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at
least 1000 mg daily) -Insulin secretaguogue (sulfonylurea or glinide): minimum half
of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half
of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor
(acarbose): minimum half of the daily maximal dose or maximum tolerated dose

- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

- Body Mass Index (BMI) below or equal to 45.0 kg/m^2

Exclusion Criteria:

- Use within the last 3 months prior to Visit 1 of: thiazoledinediones, exenatide or
liraglutide

- Cardiovascular disease, within the last 6 months prior to Visit 1, defined as:
stroke; decompensated heart failure New York Heart Association (NYHA) class III or
IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass
graft or angioplasty

- Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least
180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)

- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures according to local requirements (for UK: adequate
contraceptive measures are defined as established use of oral, injected or implanted
hormonal methods of contraception, sterilisation, intrauterine device or intrauterine
system, or consistent use of barrier methods)

- Cancer and medical history of cancer hereof (except basal cell skin cancer or
squamous cell skin cancer)
We found this trial at
46
sites
Franklin, Indiana 46131
?
mi
from
Franklin, IN
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Avon, IN
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chesterfield, Missouri 63017
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Columbus, Georgia 31904
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Durham, North Carolina 27713
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Edmonton,
Click here to add this to my saved trials
?
mi
from
Fishers, IN
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fredericksburg, Virginia 22408
?
mi
from
Fredericksburg, VA
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Hyattsville, Maryland 20782
?
mi
from
Hyattsville, MD
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
Jackson, Mississippi 39216
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Lexington, Kentucky 40503
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Menomonee Falls, Wisconsin 53051
?
mi
from
Menomonee Falls, WI
Click here to add this to my saved trials
?
mi
from
Muncie, IN
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Northridge, California 91325
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Paducah, Kentucky 42003
?
mi
from
Paducah, KY
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
Richmond, Virginia 23249
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rockville, Maryland 20852
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Salt Lake City, Utah 84107
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Simpsonville, South Carolina 29681
?
mi
from
Simpsonville, SC
Click here to add this to my saved trials
Spring Valley, California 91978
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
St. Peters, Missouri 63376
?
mi
from
St. Peters, MO
Click here to add this to my saved trials
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Tustin, California 92780
?
mi
from
Tustin, CA
Click here to add this to my saved trials
Virginia Beach, Virginia 23454
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
West Seneca, New York 14224
?
mi
from
West Seneca, NY
Click here to add this to my saved trials
Winston Salem, North Carolina 27103
?
mi
from
Winston Salem, NC
Click here to add this to my saved trials