Comparison of NN1250 Versus 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:September 2009
End Date:December 2011

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

NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

This trial is conducted in Europe and the United States of America (USA). The aim of this
trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in
subjects with type 2 diabetes never treated with insulin followed by the extension trial
investigating the long-term safety and tolerability in terms of comparing NN1250 with
insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant
enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl
peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor
treatment is approved for combination treatment together with insulin, otherwise DPP-IV
inhibitor treatment is also discontinued). Subjects who consent to participate in the
extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic
drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension
period is registered as NN1250-3643.


Inclusion Criteria:

- Type 2 diabetes mellitus

- Treatment with oral antidiabetic drugs (OADs) for at least three months before trial
start at an unchanged dose

- HbA1c: 7.0-10.0%

- Body Mass Index (BMI) no higher than 40.0 kg/m^2

- For the extension trial only: Completion of the 52 week treatment period in trial
NN1250-3579 (NCT00982644)

Exclusion Criteria:

- Treatment with exenatide or liraglutide within the last 3 months before trial start

- Cardiovascular disease within the last 6 months

- Uncontrolled treated/untreated severe hypertension

- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures

- Cancer and medical history of cancer
We found this trial at
76
sites
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Asheboro, North Carolina 27203
?
mi
from
Asheboro, NC
Click here to add this to my saved trials
Bay Minette, Alabama 36507
?
mi
from
Bay Minette, AL
Click here to add this to my saved trials
Boynton Beach, Florida 33472
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Brockton, Massachusetts 02301
?
mi
from
Brockton, MA
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60607
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Concord, California 94520
?
mi
from
Concord, CA
Click here to add this to my saved trials
Corpus Christi, Texas 78404
?
mi
from
Corpus Christi, 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
Decatur, GA
Click here to add this to my saved trials
East Providence, Rhode Island 02914
?
mi
from
East Providence, RI
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Evansville, Indiana 47725
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fort Valley, Georgia 31030
?
mi
from
Fort Valley, GA
Click here to add this to my saved trials
Goodyear, Arizona 85395
?
mi
from
Goodyear, AZ
Click here to add this to my saved trials
Greenbelt, Maryland 20770
?
mi
from
Greenbelt, MD
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
Harriman, Tennessee 37748
?
mi
from
Harriman, TN
Click here to add this to my saved trials
Henderson, Nevada 89052
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Humboldt, Tennessee 38343
?
mi
from
Humboldt, TN
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Hurst, TX
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kingston, Pennsylvania 18704
?
mi
from
Kingston, PA
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
Langhorne, Pennsylvania 19047
?
mi
from
Langhorne, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89148
?
mi
from
Las Vegas, NV
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
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
Melbourne, Florida 32901
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
Melrose Park, Pennsylvania 19027
?
mi
from
Melrose Park, PA
Click here to add this to my saved trials
Metairie, Louisiana 70002
?
mi
from
Metairie, LA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
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
National City, California 91950
?
mi
from
National City, CA
Click here to add this to my saved trials
New Port Richey, Florida 34652
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
Newberry, South Carolina 29108
?
mi
from
Newberry, SC
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
North East, Maryland 21901
?
mi
from
North East, MD
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
Northport, New York 11768
?
mi
from
Northport, NY
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
Norwalk, Connecticut 06851
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange Park, Florida 32073
?
mi
from
Orange Park, FL
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
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Palm Springs, California 92262
?
mi
from
Palm Springs, CA
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
Reisterstown, Maryland 21136
?
mi
from
Reisterstown, MD
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
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Mateo, California 94401
?
mi
from
San Mateo, CA
Click here to add this to my saved trials
Slidell, Louisiana 70461
?
mi
from
Slidell, LA
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
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. Louis, Missouri 63117
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Staten Island, New York 10301
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Sugar Land, Texas 77478
?
mi
from
Sugar Land, TX
Click here to add this to my saved trials
Tarzana, California 91356
?
mi
from
Tarzana, CA
Click here to add this to my saved trials
?
mi
from
Toledo, OH
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
West Palm Beach, Florida 33407
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
West Reading, Pennsylvania 19611
?
mi
from
West Reading, PA
Click here to add this to my saved trials
?
mi
from
Wolfsberg,
Click here to add this to my saved trials