A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/3/2019
Start Date:January 6, 2014
End Date:December 4, 2015

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A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)

This trial is conducted in the United States of America (USA). The aim of the trial is to
compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with
or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects
with type 2 diabetes.


Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least
one severe hypoglycaemic episode within last year (according to the ADA (American Diabetes
Association) definition, April 2013), b) Moderate chronic renal failure, defined as
glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (Chronic Kidney Disease
Epidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptom
unawareness, d) Exposed to insulin for more than 5 years, e) Recent episode of
hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose
measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12
weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at
least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ±
any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor,
thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For
subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated
haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index)
below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with a bolus insulin separately
or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of
any other anti-diabetic agent(s) than those stated in the inclusion criteria within the
last 26 weeks prior to Visit 1
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132
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Albany, New York 12208
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Albuquerque, New Mexico 87102
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Altoona, Pennsylvania 16602
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Anderson, South Carolina 29621
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Arlington, Texas 76012
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