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)

September 26, 2017 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

435

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Lukovit, Bulgaria, 5770
        • Novo Nordisk Investigational Site
      • Ruse, Bulgaria, 7000
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1431
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1606
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1324
        • Novo Nordisk Investigational Site
  • Canada
      • Quebec, Canada, G1N 4V3
        • Novo Nordisk Investigational Site
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 1T4
        • Novo Nordisk Investigational Site
      • Surrey, British Columbia, Canada, V3S 2N6
        • Novo Nordisk Investigational Site
      • Victoria, British Columbia, Canada, V8V 3N7
        • Novo Nordisk Investigational Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7L6
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6G 2M1
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M4S 1Y2
        • Novo Nordisk Investigational Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Novo Nordisk Investigational Site
      • Pointe Claire, Quebec, Canada, H9R 4S3
        • Novo Nordisk Investigational Site
      • Sherbrooke, Quebec, Canada, J1G 5K2
        • Novo Nordisk Investigational Site
  • Germany
      • Esslingen, Germany, 73728
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Hohenmölsen, Germany, 06679
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48145
        • Novo Nordisk Investigational Site
      • Pohlheim, Germany, 35415
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Sulzbach-Rosenberg, Germany, 92237
        • Novo Nordisk Investigational Site
  • India
      • Hyderabad, India, 600034
        • Novo Nordisk Investigational Site
    • Assam
      • Guwahati, Assam, India, 781007
        • Novo Nordisk Investigational Site
      • Guwahati, Assam, India
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560043
        • Novo Nordisk Investigational Site
      • Belgaum, Karnataka, India, 590001
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411030
        • Novo Nordisk Investigational Site
    • New Delhi
      • Delhi, New Delhi, India, 110002
        • Novo Nordisk Investigational Site
  • Israel
      • Haifa, Israel, 35152
        • Novo Nordisk Investigational Site
      • Holon, Israel, 58100
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
      • Kfar Saba, Israel, 44281
        • Novo Nordisk Investigational Site
      • Petah-Tikva, Israel, 49100
        • Novo Nordisk Investigational Site
      • Tel Hashomer, Israel, 52621
        • Novo Nordisk Investigational Site
      • Tel-Aviv, Israel, 64239
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Novo Nordisk Investigational Site
  • Turkey
      • Ankara, Turkey, 06110
        • Novo Nordisk Investigational Site
      • Antalya, Turkey, 07058
        • Novo Nordisk Investigational Site
      • Gaziantep, Turkey, 27070
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34752
        • Novo Nordisk Investigational Site
      • Izmir, Turkey, 35100
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Garden Grove, California, United States, 92844
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90807
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • San Mateo, California, United States, 94401
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32934
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Novo Nordisk Investigational Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Novo Nordisk Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017-3464
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Michigan
      • Troy, Michigan, United States, 48098
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Novo Nordisk Investigational Site
      • Saint Charles, Missouri, United States, 63303
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • Lodi, New Jersey, United States, 076444
        • Novo Nordisk Investigational Site
    • New York
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Tabor City, North Carolina, United States, 28463
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45220-2213
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Mason, Ohio, United States, 45040-6815
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104-5020
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19152
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
      • Pelzer, South Carolina, United States, 29669
        • Novo Nordisk Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Novo Nordisk Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75251
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75203
        • Novo Nordisk Investigational Site
      • Hurst, Texas, United States, 76054
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23219
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Injected subcutaneously (under the skin) once daily.
Experimental: Insulin degludec/liraglutide
Drug: insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 26
Change in HbA1c from baseline to 26 weeks.
Week 0, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
Change from baseline in FPG at week 26.
Week 0, week 26
Change From Baseline in Body Weight
Time Frame: Week 0, week 26
Change from baseline in body weight at week 26.
Week 0, 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).
After 26 weeks of treatment
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.
After 26 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2012

Primary Completion (Actual)

October 23, 2013

Study Completion (Actual)

October 23, 2013

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

September 26, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9068-3951
  • 2012-000140-97 (EudraCT Number)
  • U1111-1126-9776 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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