Clinical trial NCT01676116: The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy
Official title: The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes mellitus
* Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
* Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
* BMI (body mass index) equal to or below 40 kg/m\^2

Exclusion Criteria:

* Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
* Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
* 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 equal to or above 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 clinically 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 products
* History of chronic pancreatitis or idiopathic acute pancreatitis

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
timeFrame: Week 26
measure: Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
timeFrame: Week 26
measure: Change From Baseline in Body Weight
timeFrame: Week 0, week 26
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, week 26
measure: Number of Severe or Minor Hypoglycaemic Episodes
timeFrame: After 26 weeks of treatment
measure: Number of Adverse Events (AEs)
timeFrame: After 26 weeks of treatment
measure: Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)
timeFrame: Week 0, week 26
measure: Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).
timeFrame: Week 0, week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Goodyear
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Concord
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Encino
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fair Oaks
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Greenbrae
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Lancaster
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Lomita
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Long Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Montclair
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Northridge
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Mateo
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Ramon
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Tarzana
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Van Nuys
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Bradenton
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Orlando
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Plant City
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
city: Arlington Heights
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Rockville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Kalamazoo
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Troy
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Saint Charles
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Reno
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Nashua
country: United States
facility: Novo Nordisk Investigational Site
state: New Hampshire
city: Berlin
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Flemington
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Hamilton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Mineola
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: North Massapequa
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: West Seneca
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Morehead City
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Altoona
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Sumter
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Jellico
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Tullahoma
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Schertz
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Orem
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Saint George
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Coffs Harbour
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Merewether
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Keswick
country: Australia
facility: Novo Nordisk Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Antibes
country: France
facility: Novo Nordisk Investigational Site
city: Boulogne Billancourt
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Montigny-les-Metz
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: Nimes
country: France
facility: Novo Nordisk Investigational Site
city: Sète
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Nyíregyhaza
country: Hungary
facility: Novo Nordisk Investigational Site
city: Székesfehérvár
country: Hungary
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Lucenec
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Nitra
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Presov
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Linjawi S, Bode BW, Chaykin LB, Courreges JP, Handelsman Y, Lehmann LM, Mishra A, Simpson RW. The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial. Diabetes Ther. 2017 Feb;8(1):101-114. doi: 10.1007/s13300-016-0218-3. Epub 2016 Dec 10.
citation: 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.