Clinical trial NCT01850615: Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes
Official title: Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult 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: 2013-05-09
Enrollment: 323
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, South America, and the United States of America (USA).

The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1)
* Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1)
* Current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
* HbA1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)
* Body mass index (BMI) equal or less than 40.0 kg/m\^2

Exclusion Criteria:

* Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
* Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1)
* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1)

Primary outcomes:
measure: Change From Baseline in HbA1c
timeFrame: Week 0, week 18
Secondary outcomes:
measure: Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
timeFrame: After 18 weeks of randomised treatment
measure: Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
timeFrame: After 18 weeks of randomised treatment
measure: Change From Baseline in Body Weight
timeFrame: Week 0, week 18
measure: Number of Treatment Emergent Hypoglycaemic Episodes
timeFrame: Weeks 0-18
measure: Number of Adverse Events
timeFrame: Weeks 0-18
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Peoria
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Santa Ana
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Tarzana
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Conyers
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: New Orleans
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
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: Brooklyn
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Asheboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Downingtown
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
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: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Ogden
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Capital Federal
country: Argentina
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Godoy Cruz
country: Argentina
facility: Novo Nordisk Investigational Site
city: San Isidro
country: Argentina
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: New Dehli
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Chandigarh
country: India
facility: Novo Nordisk Investigational Site
state: Punjab
city: Coimbatore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Targu Mures
country: Romania
facility: Novo Nordisk Investigational Site
state: Mures
city: Ploiesti
country: Romania
facility: Novo Nordisk Investigational Site
state: Prahova
city: Timisoara
country: Romania
facility: Novo Nordisk Investigational Site
state: Timis
city: Brasov
country: Romania
facility: Novo Nordisk Investigational Site
city: Suceava
country: Romania
facility: Novo Nordisk Investigational Site
city: Brezice
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: Novo mesto
country: Slovenia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Peters AL, Piletic M, Ejstrud J, Salvesen-Sykes K, Snyder J, Bowering K. Baseline nocturnal glucose change: A predictor of the treatment effect of bolus intensification in insulin-treated type 2 diabetes. Diabetes Obes Metab. 2019 Jul;21(7):1752-1756. doi: 10.1111/dom.13729. Epub 2019 Apr 23.
citation: Rodbard HW, Tripathy D, Vidrio Velazquez M, Demissie M, Tamer SC, Piletic M. Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3). Diabetes Obes Metab. 2017 Oct;19(10):1389-1396. doi: 10.1111/dom.12955. Epub 2017 Jul 6.
citation: Heller S, Bowering K, Raskin P, Liebl A, Buchholtz K, Gorst-Rasmussen A, Pieber TR. The effect of basal-bolus therapy varies with baseline 1,5-anhydroglucitol level in people with Type 2 diabetes: a post hoc analysis. Diabet Med. 2018 May 26;35(9):1273-8. doi: 10.1111/dme.13693. Online ahead of print.
citation: Bowering K, Rodbard HW, Russell-Jones D, Bode B, Harris S, Piletic M, Heller S, Woo V, Babu V, Dethlefsen C, Mathieu C. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin Aspart in People with Diabetes: A Post Hoc Analysis. Diabetes Ther. 2019 Feb;10(1):177-188. doi: 10.1007/s13300-018-0553-7. Epub 2018 Dec 13.