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
NCT ID: NCT01850615
Last Updated: 2019-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
323 participants
INTERVENTIONAL
2013-09-23
2014-11-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FIAsp and basal insulin + metformin
Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.
Faster-acting insulin aspart
Administrated subcutaneously (s.c., under the skin) at each main meal.
basal insulin
Administrated subcutaneously (s.c., under the skin) once daily.
Basal insulin + metformin
Subjects will continue their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.
basal insulin
Administrated subcutaneously (s.c., under the skin) once daily.
Interventions
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Faster-acting insulin aspart
Administrated subcutaneously (s.c., under the skin) at each main meal.
basal insulin
Administrated subcutaneously (s.c., under the skin) once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Peoria, Arizona, United States
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
Novo Nordisk Investigational Site
Santa Ana, California, United States
Novo Nordisk Investigational Site
Tarzana, California, United States
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States
Novo Nordisk Investigational Site
Clearwater, Florida, United States
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States
Novo Nordisk Investigational Site
Conyers, Georgia, United States
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States
Novo Nordisk Investigational Site
Rockville, Maryland, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, United States
Novo Nordisk Investigational Site
Kalamazoo, Michigan, United States
Novo Nordisk Investigational Site
Omaha, Nebraska, United States
Novo Nordisk Investigational Site
Henderson, Nevada, United States
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States
Novo Nordisk Investigational Site
Brooklyn, New York, United States
Novo Nordisk Investigational Site
Asheboro, North Carolina, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States
Novo Nordisk Investigational Site
Downingtown, Pennsylvania, United States
Novo Nordisk Investigational Site
Reading, Pennsylvania, United States
Novo Nordisk Investigational Site
Greenville, South Carolina, United States
Novo Nordisk Investigational Site
Greer, South Carolina, United States
Novo Nordisk Investigational Site
Memphis, Tennessee, United States
Novo Nordisk Investigational Site
Fort Worth, Texas, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Novo Nordisk Investigational Site
Sugar Land, Texas, United States
Novo Nordisk Investigational Site
Ogden, Utah, United States
Novo Nordisk Investigational Site
Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Capital Federal, , Argentina
Novo Nordisk Investigational Site
Córdoba, , Argentina
Novo Nordisk Investigational Site
Godoy Cruz, , Argentina
Novo Nordisk Investigational Site
San Isidro, , Argentina
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, India
Novo Nordisk Investigational Site
Bangalore, Karnataka, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
New Dehli, New Delhi, India
Novo Nordisk Investigational Site
Chandigarh, Punjab, India
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, India
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico
Novo Nordisk Investigational Site
Mexico City, México, D.F., Mexico
Novo Nordisk Investigational Site
Târgu Mureş, Mureș County, Romania
Novo Nordisk Investigational Site
Ploieşti, Prahova, Romania
Novo Nordisk Investigational Site
Timișoara, Timiș County, Romania
Novo Nordisk Investigational Site
Brasov, , Romania
Novo Nordisk Investigational Site
Suceava, , Romania
Novo Nordisk Investigational Site
Brežice, , Slovenia
Novo Nordisk Investigational Site
Koper, , Slovenia
Novo Nordisk Investigational Site
Kranj, , Slovenia
Novo Nordisk Investigational Site
Novo Mesto, , Slovenia
Countries
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References
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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.
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.
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.
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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2012-005583-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1137-6242
Identifier Type: OTHER
Identifier Source: secondary_id
CTRI/2014/01/004289
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN1218-4049
Identifier Type: -
Identifier Source: org_study_id
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