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
421
mi
from
Golden, CO
Click here to add this to my saved trials
Altoona, Pennsylvania 16602
1056
mi
from
Altoona, PA
Click here to add this to my saved trials
347
mi
from
Arlington, TX
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
599
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
516
mi
from
Austin, TX
Click here to add this to my saved trials
Birmingham, Alabama 35205
684
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boynton Beach, Florida 33472
1285
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Burlington, North Carolina 27215
1020
mi
from
Burlington, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
721
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60607
609
mi
from
Chicago, IL
Click here to add this to my saved trials
727
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
721
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
344
mi
from
Dallas, TX
Click here to add this to my saved trials
748
mi
from
Dayton, OH
Click here to add this to my saved trials
1124
mi
from
DeLand, FL
Click here to add this to my saved trials
407
mi
from
Denver, CO
Click here to add this to my saved trials
Dunwoody, Georgia 30338
799
mi
from
Dunwoody, GA
Click here to add this to my saved trials
544
mi
from
Eagan, MN
Click here to add this to my saved trials
Escondido, California 92026
1127
mi
from
Escondido, CA
Click here to add this to my saved trials
Glen Burnie, Maryland 21061
1148
mi
from
Glen Burnie, MD
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17112
1139
mi
from
Harrisburg, PA
Click here to add this to my saved trials
572
mi
from
Houston, TX
Click here to add this to my saved trials
Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
Click here to add this to my saved trials
La Jolla, California 92037
1145
mi
from
La Jolla, CA
Click here to add this to my saved trials
Los Angeles, California 90027
1169
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Banos, California 93635
1261
mi
from
Los Banos, CA
Click here to add this to my saved trials
Madisonville, Kentucky 42431
566
mi
from
Madisonville, KY
Click here to add this to my saved trials
Metairie, Louisiana 70002
691
mi
from
Metairie, LA
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
Monterey, California 93940
1323
mi
from
Monterey, CA
Click here to add this to my saved trials
790
mi
from
Ogden, UT
Click here to add this to my saved trials
Orange Park, Florida 32073
1059
mi
from
Orange Park, FL
Click here to add this to my saved trials
Palm Springs, California 92262
1082
mi
from
Palm Springs, CA
Click here to add this to my saved trials
Pasadena, California 91105
1161
mi
from
Pasadena, CA
Click here to add this to my saved trials
856
mi
from
Peoria, AZ
Click here to add this to my saved trials
Plantation, Florida 33324
1302
mi
from
Plantation, FL
Click here to add this to my saved trials
Redondo Beach, California 90277
1180
mi
from
Redondo Beach, CA
Click here to add this to my saved trials
Reisterstown, Maryland 21136
1136
mi
from
Reisterstown, MD
Click here to add this to my saved trials
San Mateo, California 94401
1335
mi
from
San Mateo, CA
Click here to add this to my saved trials
Seattle, Washington 98122
1408
mi
from
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington 99204
1202
mi
from
Spokane, WA
Click here to add this to my saved trials
5856
mi
from
Stara Zagora,
Click here to add this to my saved trials
Staten Island, New York 10301
1282
mi
from
Staten Island, NY
Click here to add this to my saved trials
1114
mi
from
Tampa, FL
Click here to add this to my saved trials
Tarzana, California 91356
1182
mi
from
Tarzana, CA
Click here to add this to my saved trials
828
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tustin, California 92780
1152
mi
from
Tustin, CA
Click here to add this to my saved trials
West Palm Beach, Florida 33407
1280
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
22
mi
from
Wichita, KS
Click here to add this to my saved trials