The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:9/27/2017
Start Date:October 1, 2012
End Date:December 31, 2013

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This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial
is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide
(Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type
2 diabetes qualifying for treatment intensification.


Inclusion Criteria:

- Type 2 diabetes

- Insulin naïve

- Ongoing treatment with metformin or metformin in combination with either sulphonylurea
(SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice
daily (BID))

- Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both
inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for
subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or
exenatide (only BID)

Exclusion Criteria:

- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria
within 12 weeks

- Calcitonin equal to or above 50 pg/mL

- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial
infarction; unstable angina pectoris; or coronary arterial bypass graft or
angioplasty; all within 24 weeks

- Current or past (within the last 5 years) malignant neoplasms (except basal cell and
squamous cell carcinoma)
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Spring Valley, California 91978
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