The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:August 29, 2012
End Date:March 11, 2014

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The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)

This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in
controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like
peptide-1 (GLP-1) receptor agonist and OAD therapy.


Inclusion Criteria:

- Subjects with type 2 diabetes mellitus

- Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)

- Treatment with daily GLP-1 receptor agonist at maximum dose according to local label
(i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID)
Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza®
(liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable
daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated
dose) for 90 days or more prior to screening visit (Visit 1)

- BMI (body mass index) equal to or below 40 kg/m^2

Exclusion Criteria:

- Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and
sulphonylurea) for 90 days or less prior to screening visit (Visit 1)

- Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor
agonist) which in the Investigator's opinion could interfere with the blood glucose
level (e.g. systemic corticosteroids)

- Treatment with any insulin regimen (short term treatment due to intercurrent illness
including gestational diabetes is allowed at the discretion of the Investigator)

- Screening calcitonin equal to or above 50 ng/l

- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
neoplasia type 2 (MEN2)

- Cardiovascular disorders defined as: congestive heart failure (New York Heart
Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral
stroke and/or myocardial infarction within the past 52 weeks prior to screening visit
(Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation
procedures

- Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema)
according to the Investigator's opinion

- Subjects with a clinically significant, active (during the past 12 months) disease of
the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes
mellitus), neurological, genitourinary or haematological system that in the opinion of
the Investigator may confound the results of the trial or pose additional risk in
administering trial products

- History of chronic pancreatitis or idiopathic acute pancreatitis
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Colorado Springs, Colorado 80910
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Altoona, Pennsylvania 16602
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