Clinical trial NCT02773368: A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus
Official title: A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus. DUALTM IX - Add-on to SGLT2i
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: 2016-05-16
Enrollment: 420
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 globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% \[53-97 mmol/mol\] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m\^2 and below 40 kg/m\^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products

Primary outcomes:
measure: Change in HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 0, Week 26
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Week 0, Week 26
measure: Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
timeFrame: Week 0-26
measure: Insulin Dose, Total Daily Dose (U)
timeFrame: After 26 weeks
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, Week 26
measure: Number of Treatment-emergent Adverse Events
timeFrame: Week 0-26
measure: Responder (Yes/No) for HbA1c Below 7.0%
timeFrame: After 26 weeks
measure: Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
timeFrame: After 26 weeks
measure: Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
timeFrame: After 26 weeks
measure: Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
timeFrame: After 26 weeks
measure: Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
timeFrame: After 26 weeks
measure: Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
timeFrame: After 26 weeks
measure: Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
timeFrame: After 26 weeks
measure: Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
timeFrame: After 26 weeks
measure: Change From Baseline After 26 Weeks in Waist Circumference
timeFrame: After 26 weeks
measure: Change From Baseline in Fasting Lipid Profile: Cholesterol
timeFrame: After 26 weeks
measure: Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
timeFrame: After 26 weeks
measure: Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
timeFrame: After 26 weeks
measure: Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
timeFrame: After 26 weeks
measure: Change From Baseline in Fasting Lipid Profile: Triglycerides
timeFrame: After 26 weeks
measure: Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
timeFrame: After 26 weeks
measure: Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
timeFrame: After 26 weeks
measure: Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
timeFrame: After 26 weeks
measure: Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
timeFrame: After 26 weeks
measure: Change From Baseline in Systolic Blood Pressure
timeFrame: After 26 weeks
measure: Change From Baseline in Diastolic Blood Pressure
timeFrame: After 26 weeks
measure: Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
timeFrame: Week 0-26
measure: Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
timeFrame: Week 0-26
measure: Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
timeFrame: After 26 weeks
measure: Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
timeFrame: After 26 weeks
measure: Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
timeFrame: After 26 weeks
measure: Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
timeFrame: After 26 weeks
measure: Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
timeFrame: After 26 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Mission Viejo
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Northridge
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Palm Springs
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Ramon
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Boynton Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Chiefland
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Skokie
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Avon
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Rockville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Teaneck
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Albany
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: Whiteville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Mason
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Longview
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Kenosha
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Caba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Caba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Mendoza
country: Argentina
facility: Novo Nordisk Investigational Site
city: Winnipeg
country: Canada
facility: Novo Nordisk Investigational Site
state: Manitoba
city: Moncton
country: Canada
facility: Novo Nordisk Investigational Site
state: New Brunswick
city: Burlington
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Smiths Falls
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Lahti
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Rovaniemi
country: Finland
facility: Novo Nordisk Investigational Site
city: Tampere
country: Finland
facility: Novo Nordisk Investigational Site
city: Turku
country: Finland
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Komarom
country: Hungary
facility: Novo Nordisk Investigational Site
city: Salgótarján
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szekszárd
country: Hungary
facility: Novo Nordisk Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Novo Nordisk Investigational Site
city: Hyderbad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Bhopal
country: India
facility: Novo Nordisk Investigational Site
state: Madhya Pradesh
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Ludhiana
country: India
facility: Novo Nordisk Investigational Site
state: Punjab
city: Jaipur
country: India
facility: Novo Nordisk Investigational Site
state: Rajasthan
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Varanasi
country: India
facility: Novo Nordisk Investigational Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: New Delhi
country: India
facility: Novo Nordisk Investigational Site
city: Barnaul
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petesburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: St. Petersburg
country: Russian Federation
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
city: Trnava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Celje
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Koper
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Kranj
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Murska Sobota
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Trbovlje
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: Antequera
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Boadilla del Monte
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Villamartin
country: Spain
facility: Novo Nordisk Investigational Site
city: Baden
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Genève 14
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Luzern 16
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Olten
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Schaffhausen
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Winterthur
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Zollikerberg
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Philis-Tsimikas A, Billings LK, Busch R, Portillo CM, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes. Diabetes Obes Metab. 2019 Jun;21(6):1399-1408. doi: 10.1111/dom.13666. Epub 2019 Apr 4.