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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01952145




Registration number
NCT01952145
Ethics application status
Date submitted
24/09/2013
Date registered
27/09/2013
Date last updated
3/01/2019

Titles & IDs
Public title
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
Scientific title
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch)
Secondary ID [1] 0 0
2012-004413-14
Secondary ID [2] 0 0
NN9068-3952
Universal Trial Number (UTN)
Trial acronym
DUAL™ V
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - insulin degludec/liraglutide
Treatment: Drugs - insulin glargine

Experimental: Insulin degludec/liraglutide OD plus metformin -

Active comparator: Insulin glargine OD plus metformin -


Treatment: Drugs: insulin degludec/liraglutide
Insulin degludec/liraglutide is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.

Treatment: Drugs: insulin glargine
Insulin glargine is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [1] 0 0
Change From Baseline in Body Weight
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [2] 0 0
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Timepoint [2] 0 0
During 26 weeks of treatment

Eligibility
Key inclusion criteria
- Type 2 diabetes mellitus - HbA1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis - Current treatment with insulin glargine for at least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40 kg/m^2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any use of oral antidiabetic agents (OADs) (except for metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids) - Previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator) - Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine aminotransferase) 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 (1.4 mg/dL) for females, or as allowed according to local contraindications for metformin - 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) - History of chronic pancreatitis or idiopathic acute pancreatitis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/11/2014
Sample size
Target
Accrual to date
Final
557
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Blacktown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Wollongong
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Herston
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Ipswich
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Robina
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - East Ringwood
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4305 - Ipswich
Recruitment postcode(s) [5] 0 0
4226 - Robina
Recruitment postcode(s) [6] 0 0
3135 - East Ringwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
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Washington
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
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Capital Federal
Country [19] 0 0
Argentina
State/province [19] 0 0
Corrientes
Country [20] 0 0
Argentina
State/province [20] 0 0
Salta
Country [21] 0 0
Argentina
State/province [21] 0 0
Zarate
Country [22] 0 0
Greece
State/province [22] 0 0
Athens
Country [23] 0 0
Greece
State/province [23] 0 0
Ioannina
Country [24] 0 0
Greece
State/province [24] 0 0
Larissa
Country [25] 0 0
Greece
State/province [25] 0 0
Thessaloniki
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Hungary
State/province [27] 0 0
Eger
Country [28] 0 0
Hungary
State/province [28] 0 0
Gyor
Country [29] 0 0
Hungary
State/province [29] 0 0
Gyula
Country [30] 0 0
Hungary
State/province [30] 0 0
Miskolc
Country [31] 0 0
Mexico
State/province [31] 0 0
Hidalgo
Country [32] 0 0
Mexico
State/province [32] 0 0
Morelos
Country [33] 0 0
Mexico
State/province [33] 0 0
México, D.F.
Country [34] 0 0
Mexico
State/province [34] 0 0
Durango
Country [35] 0 0
Mexico
State/province [35] 0 0
Monterrey
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Kazan
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Kirov
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moscow
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Novosibirsk
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Saint-Petersburg
Country [41] 0 0
Russian Federation
State/province [41] 0 0
St. Petersburg
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Tomsk
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Volgograd
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Vsevolozhsk
Country [45] 0 0
Slovakia
State/province [45] 0 0
Bardejov
Country [46] 0 0
Slovakia
State/province [46] 0 0
Dolny Kubin
Country [47] 0 0
Slovakia
State/province [47] 0 0
Kosice
Country [48] 0 0
Slovakia
State/province [48] 0 0
Levice
Country [49] 0 0
Slovakia
State/province [49] 0 0
Lubochna
Country [50] 0 0
Slovakia
State/province [50] 0 0
Poprad
Country [51] 0 0
Slovakia
State/province [51] 0 0
Povazska Bystrica
Country [52] 0 0
Slovakia
State/province [52] 0 0
Prievidza
Country [53] 0 0
Slovakia
State/province [53] 0 0
Trnava
Country [54] 0 0
Slovakia
State/province [54] 0 0
Velky Meder
Country [55] 0 0
South Africa
State/province [55] 0 0
Gauteng
Country [56] 0 0
South Africa
State/province [56] 0 0
KwaZulu-Natal
Country [57] 0 0
South Africa
State/province [57] 0 0
Alberton
Country [58] 0 0
Spain
State/province [58] 0 0
Almería
Country [59] 0 0
Spain
State/province [59] 0 0
Granada
Country [60] 0 0
Spain
State/province [60] 0 0
Palma de Mallorca
Country [61] 0 0
Spain
State/province [61] 0 0
Sevilla
Country [62] 0 0
Spain
State/province [62] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.
Trial website
https://clinicaltrials.gov/study/NCT01952145
Trial related presentations / publications
Lingvay I, Perez Manghi F, Garcia-Hernandez P, Norwood P, Lehmann L, Tarp-Johansen MJ, Buse JB; DUAL V Investigators. Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial. JAMA. 2016 Mar 1;315(9):898-907. doi: 10.1001/jama.2016.1252. Erratum In: JAMA. 2016 May 17;315(19):2125. doi: 10.1001/jama.2016.5631. Tigkas, Stelios [corrected to Tigas, Stelios]. JAMA. 2016 May 17;315(19):2125. doi: 10.1001/jama.2016.5647. Tigkas, Stelios [corrected to Tigas, Stelios].
Hunt B, Mocarski M, Valentine WJ, Langer J. Evaluation of the long-term cost-effectiveness of IDegLira versus liraglutide added to basal insulin for patients with type 2 diabetes failing to achieve glycemic control on basal insulin in the USA. J Med Econ. 2017 Jul;20(7):663-670. doi: 10.1080/13696998.2017.1301943. Epub 2017 Mar 15.
Hunt B, Mocarski M, Valentine WJ, Langer J. Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Continued Up-Titration of Insulin Glargine U100 in Patients with Type 2 Diabetes in the USA. Adv Ther. 2017 Apr;34(4):954-965. doi: 10.1007/s12325-017-0502-2. Epub 2017 Mar 9. Erratum In: Adv Ther. 2017 Jun;34(6):1500-1501. doi: 10.1007/s12325-017-0543-6.
Norwood P, Chen R, Jaeckel E, Lingvay I, Jarlov H, Lehmann L, Heller S. Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. Diabetes Obes Metab. 2017 Nov;19(11):1562-1569. doi: 10.1111/dom.12972. Epub 2017 Jul 10.
Lingvay I, Harris S, Jaeckel E, Chandarana K, Ranthe MF, Jodar E. Insulin degludec/liraglutide (IDegLira) was effective across a range of dysglycaemia and body mass index categories in the DUAL V randomized trial. Diabetes Obes Metab. 2018 Jan;20(1):200-205. doi: 10.1111/dom.13043. Epub 2017 Jul 31.
Psota M, Psenkova MB, Racekova N, Ramirez de Arellano A, Vandebrouck T, Hunt B. Cost-effectiveness analysis of IDegLira versus basal-bolus insulin for patients with type 2 diabetes in the Slovak health system. Clinicoecon Outcomes Res. 2017 Dec 12;9:749-762. doi: 10.2147/CEOR.S143127. eCollection 2017.
Lingvay I, Handelsman Y, Linjawi S, Vilsboll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.
Meneghini L, Doshi A, Gouet D, Vilsboll T, Begtrup K, Orsy P, Ranthe MF, Lingvay I. Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin. Diabet Med. 2020 Feb;37(2):267-276. doi: 10.1111/dme.14178. Epub 2019 Nov 28.
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01952145