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:March 2010
End Date:December 2010

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

A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

This trial was conducted in Europe and North America. The aim of this clinical trial was to
compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with
insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or
DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with
oral anti-diabetic drugs (OADs).


Inclusion Criteria:

- Type 2 diabetes (diagnosed clinically) for at least 6 months

- Insulin naïve subjects (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 3 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 secretagogue (sulfonylurea (SU) 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

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

Exclusion Criteria:

- Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs),
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

- Cancer and medical history of cancer hereof (except basal cell skin cancer or
squamous cell skin cancer)
We found this trial at
49
sites
Escondido, California 92026
78
mi
from 91732
Escondido, CA
Click here to add this to my saved trials
Altoona, Pennsylvania 16602
2203
mi
from 91732
Altoona, PA
Click here to add this to my saved trials
1205
mi
from 91732
Arlington, TX
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
1713
mi
from 91732
Arlington Heights, IL
Click here to add this to my saved trials
1215
mi
from 91732
Austin, TX
Click here to add this to my saved trials
Birmingham, Alabama 35205
1785
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Boynton Beach, Florida 33472
2301
mi
from 91732
Boynton Beach, FL
Click here to add this to my saved trials
Burlington, North Carolina 27215
2171
mi
from 91732
Burlington, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
1855
mi
from 91732
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60607
1728
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
1875
mi
from 91732
Crestview Hills, KY
Click here to add this to my saved trials
1220
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1899
mi
from 91732
Dayton, OH
Click here to add this to my saved trials
2177
mi
from 91732
DeLand, FL
Click here to add this to my saved trials
818
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Dunwoody, Georgia 30338
1920
mi
from 91732
Dunwoody, GA
Click here to add this to my saved trials
1511
mi
from 91732
Eagan, MN
Click here to add this to my saved trials
Glen Burnie, Maryland 21061
2301
mi
from 91732
Glen Burnie, MD
Click here to add this to my saved trials
807
mi
from 91732
Golden, CO
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17112
2287
mi
from 91732
Harrisburg, PA
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Kingsport, Tennessee 37660
1994
mi
from 91732
Kingsport, TN
Click here to add this to my saved trials
La Jolla, California 92037
95
mi
from 91732
La Jolla, CA
Click here to add this to my saved trials
Los Angeles, California 90027
16
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Los Banos, California 93635
260
mi
from 91732
Los Banos, CA
Click here to add this to my saved trials
Madisonville, Kentucky 42431
1719
mi
from 91732
Madisonville, KY
Click here to add this to my saved trials
Metairie, Louisiana 70002
1649
mi
from 91732
Metairie, LA
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Monterey, California 93940
279
mi
from 91732
Monterey, CA
Click here to add this to my saved trials
593
mi
from 91732
Ogden, UT
Click here to add this to my saved trials
Orange Park, Florida 32073
2130
mi
from 91732
Orange Park, FL
Click here to add this to my saved trials
Palm Springs, California 92262
83
mi
from 91732
Palm Springs, CA
Click here to add this to my saved trials
Pasadena, California 91105
9
mi
from 91732
Pasadena, CA
Click here to add this to my saved trials
333
mi
from 91732
Peoria, AZ
Click here to add this to my saved trials
Plantation, Florida 33324
2308
mi
from 91732
Plantation, FL
Click here to add this to my saved trials
Redondo Beach, California 90277
26
mi
from 91732
Redondo Beach, CA
Click here to add this to my saved trials
Reisterstown, Maryland 21136
2289
mi
from 91732
Reisterstown, MD
Click here to add this to my saved trials
San Mateo, California 94401
341
mi
from 91732
San Mateo, CA
Click here to add this to my saved trials
Seattle, Washington 98122
961
mi
from 91732
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington 99204
938
mi
from 91732
Spokane, WA
Click here to add this to my saved trials
6672
mi
from 91732
Stara Zagora,
Click here to add this to my saved trials
Staten Island, New York 10301
2428
mi
from 91732
Staten Island, NY
Click here to add this to my saved trials
2133
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Tarzana, California 91356
31
mi
from 91732
Tarzana, CA
Click here to add this to my saved trials
435
mi
from 91732
Tucson, AZ
Click here to add this to my saved trials
Tustin, California 92780
25
mi
from 91732
Tustin, CA
Click here to add this to my saved trials
West Palm Beach, Florida 33407
2300
mi
from 91732
West Palm Beach, FL
Click here to add this to my saved trials
1178
mi
from 91732
Wichita, KS
Click here to add this to my saved trials