Overview

A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

Status:
Completed
Trial end date:
2019-07-13
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Hypoglycemic Agents
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Liraglutide
Xultophy
Criteria
Inclusion Criteria:

- Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial

- Type 2 diabetes mellitus (clinically diagnosed)

- Male or female, age at least 18 years at the time of signing informed consent

- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a
median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above
8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or
when approximately 50% of the randomised subjects have an HbA1c below or equal to
8.3%, the remaining subjects randomised must have an HbA1c above 8.3%

- Current treatment for at least 90 calendar days prior to screening with metformin
plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or
thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects
should be on a stable dose of:

- Metformin (above or equal to 1500 mg or max tolerated dose) or

- Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above
or equal to half of the max approved dose according to local label) or

- Metformin (above or equal to 1500 mg or max tolerated dose) and glinides (above or
equal to half of the max approved dose according to local label) or

- Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase
inhibitors (above or equal to half of the max approved dose according to local label)
or

- Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones
(above or equal to half of the max approved dose according to local label)

Exclusion Criteria:

- Treatment with insulin (except for short-term treatment at the discretion of the
investigator)

- Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4
inhibitors within 90 days prior to screening

- Impaired liver function, defined as alanine aminotransferase above or equal to 2.5
times upper normal range

- Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for
males and above or equal to 125 μmol/L for females, or as defined according to local
contraindications for metformin

- Screening calcitonin above or equal to 50 ng/L

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

- Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis
of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the
last 12 months prior to screening and/or planned coronary, carotid or peripheral
artery revascularisation procedures

- Severe uncontrolled treated or untreated hypertension (systolic blood pressure above
or equal to 180 mmHg or diastolic blood pressure above or equal to 100 mmHg

- Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment

- History of pancreatitis (acute or chronic)