A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms (DUAL™ VI)
April 24, 2017 updated by: Novo Nordisk A/S
This trial is conducted in Europe, North America and the United States of America.
The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
420
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
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Linz, Austria, 4021
- Novo Nordisk Investigational Site
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Mödling, Austria, 2340
- Novo Nordisk Investigational Site
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St. Stefan, Austria, 8511
- Novo Nordisk Investigational Site
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Wien, Austria, 1090
- Novo Nordisk Investigational Site
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Wien, Austria, 1130
- Novo Nordisk Investigational Site
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Wien, Austria, 1230
- Novo Nordisk Investigational Site
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Wien, Austria, 1010
- Novo Nordisk Investigational Site
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Kozloduy, Bulgaria, 3320
- Novo Nordisk Investigational Site
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Lukovit, Bulgaria, 5770
- Novo Nordisk Investigational Site
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Ruse, Bulgaria, 7000
- Novo Nordisk Investigational Site
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Sofia, Bulgaria, 1784
- Novo Nordisk Investigational Site
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Varna, Bulgaria, 9002
- Novo Nordisk Investigational Site
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British Columbia
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Burnaby, British Columbia, Canada, V5G 1T4
- Novo Nordisk Investigational Site
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Coquitlam, British Columbia, Canada, V3K 3P4
- Novo Nordisk Investigational Site
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Surrey, British Columbia, Canada, V3S 2N6
- Novo Nordisk Investigational Site
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
- Novo Nordisk Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 2M5
- Novo Nordisk Investigational Site
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Liverpool, Nova Scotia, Canada, B0T 1K0
- Novo Nordisk Investigational Site
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Ontario
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London, Ontario, Canada, N6G 2M1
- Novo Nordisk Investigational Site
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Waterloo, Ontario, Canada, N2J 1C4
- Novo Nordisk Investigational Site
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Olomouc, Lazce, Czechia, 77900
- Novo Nordisk Investigational Site
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Plzen, Czechia, 32600
- Novo Nordisk Investigational Site
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Plzen, Czechia, 30166
- Novo Nordisk Investigational Site
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Praha 4, Czechia, 140 46
- Novo Nordisk Investigational Site
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Trutnov, Czechia, 541 01
- Novo Nordisk Investigational Site
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Budapest, Hungary, 1089
- Novo Nordisk Investigational Site
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Budapest, Hungary, 1135
- Novo Nordisk Investigational Site
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Debrecen, Hungary, 4043
- Novo Nordisk Investigational Site
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Szombathely, Hungary, H-9700
- Novo Nordisk Investigational Site
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Zalaegerszeg, Hungary, 8900
- Novo Nordisk Investigational Site
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Barnaul, Russian Federation, 656024
- Novo Nordisk Investigational Site
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Barnaul, Russian Federation, 656045
- Novo Nordisk Investigational Site
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Cheboksary, Russian Federation, 428000
- Novo Nordisk Investigational Site
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Saint-Petersburg, Russian Federation, 194358
- Novo Nordisk Investigational Site
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Samara, Russian Federation, 443041
- Novo Nordisk Investigational Site
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St. Petersburg, Russian Federation, 194354
- Novo Nordisk Investigational Site
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Belgrade, Serbia, 11000
- Novo Nordisk Investigational Site
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Bratislava, Slovakia, 851 01
- Novo Nordisk Investigational Site
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Bratislava, Slovakia, 81108
- Novo Nordisk Investigational Site
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Bratislava, Slovakia, 82102
- Novo Nordisk Investigational Site
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Dunajska Streda, Slovakia, 92901
- Novo Nordisk Investigational Site
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Sabinov, Slovakia, 08301
- Novo Nordisk Investigational Site
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Vranov nad Toplou, Slovakia, 09301
- Novo Nordisk Investigational Site
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Zilina, Slovakia, 01207
- Novo Nordisk Investigational Site
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Alabama
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Hamilton, Alabama, United States, 35570
- Novo Nordisk Investigational Site
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Arizona
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Chandler, Arizona, United States, 85224
- Novo Nordisk Investigational Site
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Glendale, Arizona, United States, 85306-4652
- Novo Nordisk Investigational Site
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Glendale, Arizona, United States, 85308
- Novo Nordisk Investigational Site
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Mesa, Arizona, United States, 85213
- Novo Nordisk Investigational Site
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Phoenix, Arizona, United States, 85018
- Novo Nordisk Investigational Site
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Phoenix, Arizona, United States, 85020
- Novo Nordisk Investigational Site
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Tucson, Arizona, United States, 85741
- Novo Nordisk Investigational Site
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California
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Anaheim, California, United States, 92801
- Novo Nordisk Investigational Site
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Palm Springs, California, United States, 92262
- Novo Nordisk Investigational Site
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Walnut Creek, California, United States, 94598
- Novo Nordisk Investigational Site
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Colorado
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Colorado Springs, Colorado, United States, 80904
- Novo Nordisk Investigational Site
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Florida
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Boynton Beach, Florida, United States, 33472
- Novo Nordisk Investigational Site
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Clearwater, Florida, United States, 33765
- Novo Nordisk Investigational Site
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Hallandale Beach, Florida, United States, 33009
- Novo Nordisk Investigational Site
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Miami, Florida, United States, 33173
- Novo Nordisk Investigational Site
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Orlando, Florida, United States, 32801
- Novo Nordisk Investigational Site
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Tampa, Florida, United States, 33603
- Novo Nordisk Investigational Site
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Georgia
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Conyers, Georgia, United States, 30094-5965
- Novo Nordisk Investigational Site
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Idaho
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Blackfoot, Idaho, United States, 83221
- Novo Nordisk Investigational Site
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Illinois
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Chicago, Illinois, United States, 60607
- Novo Nordisk Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46254
- Novo Nordisk Investigational Site
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Kentucky
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Crestview Hills, Kentucky, United States, 41017-3464
- Novo Nordisk Investigational Site
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Michigan
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Troy, Michigan, United States, 48098
- Novo Nordisk Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89103
- Novo Nordisk Investigational Site
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New Hampshire
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Nashua, New Hampshire, United States, 03063
- Novo Nordisk Investigational Site
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New York
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West Seneca, New York, United States, 14224
- Novo Nordisk Investigational Site
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North Carolina
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Greensboro, North Carolina, United States, 27408
- Novo Nordisk Investigational Site
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Oklahoma
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Norman, Oklahoma, United States, 73069
- Novo Nordisk Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Novo Nordisk Investigational Site
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South Carolina
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Greer, South Carolina, United States, 29651
- Novo Nordisk Investigational Site
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Spartanburg, South Carolina, United States, 29303
- Novo Nordisk Investigational Site
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Tennessee
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Humboldt, Tennessee, United States, 38343
- Novo Nordisk Investigational Site
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Kingsport, Tennessee, United States, 37660
- Novo Nordisk Investigational Site
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Texas
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Houston, Texas, United States, 77008
- Novo Nordisk Investigational Site
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Katy, Texas, United States, 77450
- Novo Nordisk Investigational Site
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San Antonio, Texas, United States, 78215
- Novo Nordisk Investigational Site
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San Antonio, Texas, United States, 78240
- Novo Nordisk Investigational Site
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Virginia
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Newport News, Virginia, United States, 23606
- Novo Nordisk Investigational Site
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Richmond, Virginia, United States, 23294
- Novo Nordisk Investigational Site
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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:
- Type 2 diabetes mellitus
- Male or female equal to or above 18 years of age
- HbA1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
- Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
- Body Mass Index (BMI) below or equal to 40 kg/m^2
Exclusion Criteria:
- Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
- Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
- Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
- Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)
- Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin
- Screening calcitonin above or equal to 50 ng/L
- Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- History of pancreatitis (acute or chronic)
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Once weekly titration
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For subcutaneous (s.c., under the skin) injection, once daily.
Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.
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Experimental: Twice weekly titration
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For subcutaneous (s.c., under the skin) injection, once daily.
Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in HbA1c
Time Frame: Week 0, week 32
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Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.
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Week 0, week 32
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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HbA1c Below 7.0%
Time Frame: Week 0, week 32
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Responders to HbA1c below 7% after 32 weeks of treatment.
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Week 0, week 32
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HbA1c Below or Equal to 6.5%
Time Frame: Week 0, week 32
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Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.
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Week 0, week 32
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Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: Week 0-32
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An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
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Week 0-32
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Safety and Efficacy of Insulin Degludec/Liraglutide(IDegLira) Titrated Once Weekly (1 Wk) vs. Twice Weekly (2 Wk) in Patients (pts) with T2D Uncontrolled on Oral Antidiabetic Drugs: DUAL VI Study; Stewart B. Harris et al. American Diabetes Association - 76th Annual Scientific Sessions; 10 June 2016
- Harris SB, Kocsis G, Prager R, Ridge T, Chandarana K, Halladin N, Jabbour S. Safety and efficacy of IDegLira titrated once weekly versus twice weekly in patients with type 2 diabetes uncontrolled on oral antidiabetic drugs: DUAL VI randomized clinical trial. Diabetes Obes Metab. 2017 Jun;19(6):858-865. doi: 10.1111/dom.12892. Epub 2017 Mar 3.
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)
November 21, 2014
Primary Completion (Actual)
December 23, 2015
Study Completion (Actual)
December 23, 2015
Study Registration Dates
First Submitted
November 19, 2014
First Submitted That Met QC Criteria
November 19, 2014
First Posted (Estimate)
November 21, 2014
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9068-4056
- 2012-004625-25 (EudraCT Number)
- U1111-1135-6634 (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.