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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01618162
First received: June 11, 2012
Last updated: December 20, 2016
Last verified: December 2016
  Purpose
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec/liraglutide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]
    Change in HbA1c from baseline to 26 weeks.


Secondary Outcome Measures:
  • Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) [ Time Frame: Week 26 ]
    Percentage of subjects having HbA1c below 7% at week 26.

  • Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) [ Time Frame: Week 26 ]
    Percentage of subjects having HbA1c below 6.5% at week 26

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

  • Change From Baseline in Body Weight [ Time Frame: Week 0, week 26 ]
    Change from baseline in body weight at week 26.

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

    An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.

    Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.

    Minor hypoglycaemic episodes were defined as:

    1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.
    2. Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).

    Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

    Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).


  • Number of Adverse Events (AEs) [ Time Frame: After 26 weeks of treatment ]
    An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.


Enrollment: 435
Study Start Date: August 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin degludec/liraglutide Drug: insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Placebo Comparator: Placebo Drug: placebo
Injected subcutaneously (under the skin) once daily.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618162

  Show 87 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01618162     History of Changes
Other Study ID Numbers: NN9068-3951  2012-000140-97  U1111-1126-9776 
Study First Received: June 11, 2012
Results First Received: December 20, 2016
Last Updated: December 20, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Insulin, Long-Acting
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 24, 2017