Diabetes Mellitus, Type 2 Clinical Trial
— DUALâ„¢ IIOfficial title:
A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes
Verified date | December 2018 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.
Status | Completed |
Enrollment | 413 |
Est. completion date | October 4, 2012 |
Est. primary completion date | October 1, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects with type 2 diabetes - HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive) - Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label) - BMI (Body Mass Index) more than or equal to 27 kg/m^2 Exclusion Criteria: - Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start - Impaired liver function - Impaired renal function - Screening calcitonin equal to or above 50 ng/l - Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) - 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 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures - Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg) - Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion - History of chronic pancreatitis or idiopathic acute pancreatitis |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Novo Nordisk Investigational Site | Burgas | |
Bulgaria | Novo Nordisk Investigational Site | Haskovo | |
Bulgaria | Novo Nordisk Investigational Site | Lukovit | |
Bulgaria | Novo Nordisk Investigational Site | Plovdiv | |
Bulgaria | Novo Nordisk Investigational Site | Ruse | |
Bulgaria | Novo Nordisk Investigational Site | Sofia | |
Denmark | Novo Nordisk Investigational Site | Århus C | |
Denmark | Novo Nordisk Investigational Site | Gentofte | |
Denmark | Novo Nordisk Investigational Site | Hellerup | |
Hungary | Novo Nordisk Investigational Site | Budapest | |
Hungary | Novo Nordisk Investigational Site | Debrecen | |
Hungary | Novo Nordisk Investigational Site | Eger | |
Hungary | Novo Nordisk Investigational Site | Szombathely | |
India | Novo Nordisk Investigational Site | Chennai | Tamil Nadu |
India | Novo Nordisk Investigational Site | Dhantoli, Nagpur | |
India | Novo Nordisk Investigational Site | Kolkata | West Bengal |
India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
India | Novo Nordisk Investigational Site | Pune | Maharashtra |
Slovenia | Novo Nordisk Investigational Site | Koper | |
Slovenia | Novo Nordisk Investigational Site | Ljubljana | |
Slovenia | Novo Nordisk Investigational Site | Novo mesto | |
Switzerland | Novo Nordisk Investigational Site | Basel | |
Switzerland | Novo Nordisk Investigational Site | Bern | |
Switzerland | Novo Nordisk Investigational Site | Interlaken-Unterseen | |
Switzerland | Novo Nordisk Investigational Site | Lausanne | |
Switzerland | Novo Nordisk Investigational Site | Luzern 16 | |
Switzerland | Novo Nordisk Investigational Site | St. Gallen | |
United States | Novo Nordisk Investigational Site | Albany | New York |
United States | Novo Nordisk Investigational Site | Anaheim | California |
United States | Novo Nordisk Investigational Site | Arlington | Texas |
United States | Novo Nordisk Investigational Site | Arlington Heights | Illinois |
United States | Novo Nordisk Investigational Site | Asheboro | North Carolina |
United States | Novo Nordisk Investigational Site | Austin | Texas |
United States | Novo Nordisk Investigational Site | Avon | Illinois |
United States | Novo Nordisk Investigational Site | Beaver | Pennsylvania |
United States | Novo Nordisk Investigational Site | Chapel Hill | North Carolina |
United States | Novo Nordisk Investigational Site | Chesterfield | Missouri |
United States | Novo Nordisk Investigational Site | Chicago | Illinois |
United States | Novo Nordisk Investigational Site | Colorado Springs | Colorado |
United States | Novo Nordisk Investigational Site | Crystal Lake | Illinois |
United States | Novo Nordisk Investigational Site | Dallas | Texas |
United States | Novo Nordisk Investigational Site | Dallas | Texas |
United States | Novo Nordisk Investigational Site | Dallas | Texas |
United States | Novo Nordisk Investigational Site | Greenfield | Indiana |
United States | Novo Nordisk Investigational Site | Greensboro | North Carolina |
United States | Novo Nordisk Investigational Site | Greer | South Carolina |
United States | Novo Nordisk Investigational Site | Gurnee | Illinois |
United States | Novo Nordisk Investigational Site | Hickory | North Carolina |
United States | Novo Nordisk Investigational Site | Huntsville | Alabama |
United States | Novo Nordisk Investigational Site | Hurst | Texas |
United States | Novo Nordisk Investigational Site | Indianapolis | Indiana |
United States | Novo Nordisk Investigational Site | Lawrenceville | New Jersey |
United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
United States | Novo Nordisk Investigational Site | Los Angeles | California |
United States | Novo Nordisk Investigational Site | Melbourne | Florida |
United States | Novo Nordisk Investigational Site | Metairie | Louisiana |
United States | Novo Nordisk Investigational Site | Metairie | Louisiana |
United States | Novo Nordisk Investigational Site | Methuen | Massachusetts |
United States | Novo Nordisk Investigational Site | Miami | Florida |
United States | Novo Nordisk Investigational Site | Muncie | Indiana |
United States | Novo Nordisk Investigational Site | Nashua | New Hampshire |
United States | Novo Nordisk Investigational Site | Nashville | Tennessee |
United States | Novo Nordisk Investigational Site | New Albany | Indiana |
United States | Novo Nordisk Investigational Site | North Dartmouth | Massachusetts |
United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
United States | Novo Nordisk Investigational Site | Rockville | Maryland |
United States | Novo Nordisk Investigational Site | Roswell | Georgia |
United States | Novo Nordisk Investigational Site | Saint Charles | Missouri |
United States | Novo Nordisk Investigational Site | Salt Lake City | Utah |
United States | Novo Nordisk Investigational Site | San Antonio | Texas |
United States | Novo Nordisk Investigational Site | San Antonio | Texas |
United States | Novo Nordisk Investigational Site | San Antonio | Texas |
United States | Novo Nordisk Investigational Site | Simpsonville | South Carolina |
United States | Novo Nordisk Investigational Site | Slidell | Louisiana |
United States | Novo Nordisk Investigational Site | Smithtown | New York |
United States | Novo Nordisk Investigational Site | Southfield | Michigan |
United States | Novo Nordisk Investigational Site | Statesville | North Carolina |
United States | Novo Nordisk Investigational Site | Sugar Land | Texas |
United States | Novo Nordisk Investigational Site | Toms River | New Jersey |
United States | Novo Nordisk Investigational Site | Tustin | California |
United States | Novo Nordisk Investigational Site | Ventura | California |
United States | Novo Nordisk Investigational Site | Vestavia Hills | Alabama |
United States | Novo Nordisk Investigational Site | Waltham | Massachusetts |
United States | Novo Nordisk Investigational Site | Waterbury | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
United States, Bulgaria, Denmark, Hungary, India, Slovenia, Switzerland,
Buse JB, Vilsbøll T, Thurman J, Blevins TC, Langbakke IH, Bøttcher SG, Rodbard HW; NN9068-3912 (DUAL-II) Trial Investigators. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care. 2014 No — View Citation
Ericsson Å, Lundqvist A. Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden. Appl Health Econ Health Policy. 2017 Apr;15(2):237-248. doi: 10.1007/s40258-016-0301-y. — View Citation
Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22. — View Citation
King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsbøll T. A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target — View Citation
Lingvay I, Handelsman Y, Linjawi S, Vilsbøll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2018 Nov 1. doi: 10.4158/EP-2018-0284. [Epub ahead of print] — View Citation
Vilsbøll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone. Clin Drug Investig. 2016 Apr;36(4):293-303. doi: 10.1007/s40261-016-0376 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Observed mean change from baseline in HbA1c after 26 Weeks of treatment. | Week 0, week 26 | |
Secondary | Change in Body Weight | Observed mean change from baseline in body weight after 26 Weeks of treatment. | Week 0, week 26 |
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