Clinical trial NCT01618162: 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
Official title: 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
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: 2012-06-13
Enrollment: 435
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
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 Fasting Plasma Glucose (FPG)
timeFrame: Week 0, week 26
measure: Change From Baseline in Body Weight
timeFrame: Week 0, week 26
measure: Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes
timeFrame: After 26 weeks of treatment
measure: Number of Adverse Events (AEs)
timeFrame: After 26 weeks of treatment
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Garden Grove
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: La Jolla
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Long Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Mateo
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Kissimmee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Melbourne
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: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Meridian
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Gurnee
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Crestview Hills
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Rockville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Troy
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Chesterfield
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Saint Charles
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Nashua
country: United States
facility: Novo Nordisk Investigational Site
state: New Hampshire
city: Lodi
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: West Seneca
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Tabor City
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Franklin
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Mason
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Beaver
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Pelzer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Chattanooga
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: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Hurst
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Newport News
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Lukovit
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Ruse
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Burnaby
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Cambridge
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Mirabel
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Novo Nordisk Investigational Site
city: Esslingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hohenmölsen
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Pohlheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Sulzbach-Rosenberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Guwahati
country: India
facility: Novo Nordisk Investigational Site
state: Assam
city: Guwahati
country: India
facility: Novo Nordisk Investigational Site
state: Assam
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Belgaum
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Delhi
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Holon
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah-Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel-Aviv
country: Israel
facility: Novo Nordisk Investigational Site
city: Manati
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Antalya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Gaziantep
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Izmir
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.
citation: Rodbard HW, Bode BW, Harris SB, Rose L, Lehmann L, Jarlov H, Thurman J; Dual Action of Liraglutide and insulin degludec (DUAL) IV trial investigators. Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naive people with Type 2 diabetes: the DUAL IV trial. Diabet Med. 2017 Feb;34(2):189-196. doi: 10.1111/dme.13256. Epub 2016 Oct 7.