The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01618162
• Date of registration: 11/06/2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy DUAL™IV
• Scientific title: The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
• Date of first enrolment: August 29, 2012
• Target sample size: 435
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01618162
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Germany, India, Israel, Macedonia, The Former Yugoslav Republic of, Puerto Rico, Turkey, United States

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with type 2 diabetes mellitus

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

- Subjects on stable daily dose of sulphonylurea (above or equal to half of the max
approved dose according to local label) with or without metformin (above or equal to
1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)

- Body Mass Index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

- Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in
combinationwith metformin) below or equal to 90 days prior to screening visit (Visit
1)

- Use of any drug (other than SU in monotherapy or in combination with metformin), which
in the Investigators opinion could interfere with the blood glucose level (e.g.
systemic corticosteroids)

- Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g.
exenatide, liraglutide)

- 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 above or equal to 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 clinical 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 product

- History of chronic pancreatitis or idiopathic acute pancreatitis



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 2

Intervention(s)

Drug: placebo

Drug: insulin degludec/liraglutide

Primary Outcome(s)

Change in Glycosylated Haemoglobin (HbA1c) [Time Frame: Week 0, Week 26]

Secondary Outcome(s)

Change From Baseline in Body Weight [Time Frame: Week 0, week 26]

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) [Time Frame: Week 26]

Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes [Time Frame: After 26 weeks of treatment]

Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) [Time Frame: Week 26]

Number of Adverse Events (AEs) [Time Frame: After 26 weeks of treatment]

Change From Baseline in Fasting Plasma Glucose (FPG) [Time Frame: Week 0, week 26]

Secondary ID(s)

U1111-1126-9776

2012-000140-97

NN9068-3951

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01618162