Clinical trial NCT01617434: The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
Official title: The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
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: 2012-06-12
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
* HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
* Body mass index (BMI) 20-45 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
* Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
* Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
* Impaired liver or renal function
* Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
* Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
* Known or suspected abuse of alcohol or narcotics

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
timeFrame: Week 0 to Week 26
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
timeFrame: Week 0 to Week 26
measure: Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26
timeFrame: Week 0 to Week 26
measure: Change in Body Weight From Baseline to Week 26
timeFrame: Week 0 to Week 26
measure: Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)
timeFrame: At Week 26
measure: Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)
timeFrame: At Week 26
measure: Number of Adverse Events (AEs) During The Randomised Treatment Period
timeFrame: Week 0 to Week 26 + 7 days follow up
measure: Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period
timeFrame: Week 0 to Week 26 + 7 days follow up
measure: Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period
timeFrame: Week 0 to Week 26 + 7 days follow up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
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: San Ramon
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Tustin
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Ventura
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: Gurnee
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Greenfield
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Methuen
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Newington
country: United States
facility: Novo Nordisk Investigational Site
state: New Hampshire
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: McMurray
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Spartanburg
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
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: Sugarland
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: Midlothian
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Martinsburg
country: United States
facility: Novo Nordisk Investigational Site
state: West Virginia
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: Córdoba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Coquitlam
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Burlington
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Smiths Falls
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Westmount
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Kerava
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: Ylitornio
country: Finland
facility: Novo Nordisk Investigational Site
city: Aschaffenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Lauterberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Gelnhausen
country: Germany
facility: Novo Nordisk Investigational Site
city: Gifhorn
country: Germany
facility: Novo Nordisk Investigational Site
city: Hohenmölsen
country: Germany
facility: Novo Nordisk Investigational Site
city: Mannheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Mayen
country: Germany
facility: Novo Nordisk Investigational Site
city: Oldenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Visakhapatnam
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Rohtak
country: India
facility: Novo Nordisk Investigational Site
state: Haryana
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Indore
country: India
facility: Novo Nordisk Investigational Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Jaipur
country: India
facility: Novo Nordisk Investigational Site
state: Rajasthan
city: Kolkatta
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
city: Thriruvananthapuram
country: India
facility: Novo Nordisk Investigational Site
city: Pachuca
country: Mexico
facility: Novo Nordisk Investigational Site
state: Hidalgo
city: Mexico, D.F.
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Almere
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Breda
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Eindhoven
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Hoogeveen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Leiden
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Velp
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Venlo
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zoetermeer
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zwijndrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Nis
country: Serbia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ahmann A, Rodbard HW, Rosenstock J, Lahtela JT, de Loredo L, Tornoe K, Boopalan A, Nauck MA; NN2211-3917 Study Group. Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2015 Nov;17(11):1056-64. doi: 10.1111/dom.12539. Epub 2015 Sep 10.
citation: Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18.