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
Melrose Park, Pennsylvania 19027
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Atlanta, GA
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Bradenton, Florida 34208
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Chattanooga, Tennessee 37404
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Chino, California 91710
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Clearwater, Florida 33759
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Concord, California 94520
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Concord, CA
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Dallas, TX
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Detroit, Michigan 48201
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Detroit, MI
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Evansville, Indiana 47725
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Franklin, OH
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Goodyear, Arizona 85395
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Greenbrae, California 94904
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Greensboro, North Carolina 27408
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Greenville, North Carolina 27834
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Huntsville, Alabama 35801
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Hurst, TX
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Irving, TX
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Jefferson City, Missouri 65109
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Kissimmee, Florida 34741
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Lawrenceville, New Jersey 08648
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Mesa, AZ
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Metairie, Louisiana 70002
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Miami, FL
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Nashville, Tennessee 37232
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National City, California 91950
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Olympia, Washington 98502
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Palm Springs, California 92262
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Renton, Washington 98057
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Rockville, Maryland 20852
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San Antonio, Texas 78229
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Slidell, Louisiana 70461
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Springfield, Illinois 62704
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Staten Island, New York 10301
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Tampa, FL
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Toms River, New Jersey 08755
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Waltham, Massachusetts 02453
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West Palm Beach, Florida 33407
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West Seneca, New York 14224
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