Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2011
End Date:January 2012

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A Trial Comparing the Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Subjects With Type 2 Diabetes Mellitus (BEGIN™: COMPARE)

This trial is conducted in the United States of America (USA). The aim of this trial is to
compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in
subjects with type 2 diabetes.


Inclusion Criteria:

- Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation
(visit 2)

- Current treatment with basal-only insulin (no prandial insulin) consisting of either
insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn
(NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation
(visit 2), in combination with stable doses of OAD(s) (metformin, insulin
secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or
dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose
or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks
prior to randomisation (visit 2)

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

- Body mass index (BMI) below or equal to 45 kg/m^2

- Ability and willingness to adhere to the protocol including self-measured plasma
glucose (SMPG) according to the protocol

Exclusion Criteria:

- Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit
2)

- Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12
weeks prior to randomisation (visit 2)

- Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the
last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial
physician)

- Previous participation in this trial. Participation is defined as randomised.
Re-screening is allowed once during the recruitment period

- Known or suspected hypersensitivity to trial products or related products

- The receipt of any investigational drug within 4 weeks prior to randomisation (visit
2)
We found this trial at
42
sites
Goodyear, Arizona 85395
325
mi
from 91732
Goodyear, AZ
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1922
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Atlanta, GA
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1215
mi
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Austin, TX
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Bradenton, Florida 34208
2144
mi
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Bradenton, FL
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Chattanooga, Tennessee 37404
1855
mi
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Chattanooga, TN
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Chino, California 91710
19
mi
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Chino, CA
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Clearwater, Florida 33759
2122
mi
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Clearwater, FL
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Concord, California 94520
353
mi
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Concord, CA
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1220
mi
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Dallas, TX
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Detroit, Michigan 48201
1966
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Detroit, MI
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Evansville, Indiana 47725
1717
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Evansville, IN
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1891
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Franklin, OH
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Greenbrae, California 94904
367
mi
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Greenbrae, CA
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Greensboro, North Carolina 27408
2150
mi
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Greensboro, NC
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Greenville, North Carolina 27834
2290
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Greenville, NC
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Huntsville, Alabama 35801
1786
mi
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Huntsville, AL
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1201
mi
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Hurst, TX
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1214
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Irving, TX
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Jefferson City, Missouri 65109
1466
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Jefferson City, MO
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Kissimmee, Florida 34741
2187
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Kissimmee, FL
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Lawrenceville, New Jersey 08648
2396
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Lawrenceville, NJ
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Melrose Park, Pennsylvania 19027
2376
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Melrose Park, PA
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355
mi
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Mesa, AZ
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Metairie, Louisiana 70002
1649
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Metairie, LA
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2321
mi
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Miami, FL
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Nashville, Tennessee 37232
1762
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Nashville, TN
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National City, California 91950
110
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National City, CA
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Olympia, Washington 98502
931
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Olympia, WA
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1289
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Omaha, NE
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Palm Springs, California 92262
83
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Palm Springs, CA
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345
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Phoenix, AZ
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Renton, Washington 98057
952
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Renton, WA
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Rockville, Maryland 20852
2275
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Rockville, MD
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San Antonio, Texas 78229
1182
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San Antonio, TX
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Slidell, Louisiana 70461
1666
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Slidell, LA
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Springfield, Illinois 62704
1606
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Springfield, IL
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Staten Island, New York 10301
2428
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Staten Island, NY
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2133
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Tampa, FL
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Toms River, New Jersey 08755
2425
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Toms River, NJ
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Waltham, Massachusetts 02453
2568
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Waltham, MA
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West Palm Beach, Florida 33407
2300
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West Palm Beach, FL
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West Seneca, New York 14224
2187
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West Seneca, NY
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