This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 (onset® 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01850615
First received: April 17, 2013
Last updated: March 29, 2017
Last verified: March 2017
April 17, 2013
March 29, 2017
September 23, 2013
November 17, 2014   (Final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: Week 0, week 18 ]
Same as current
Complete list of historical versions of study NCT01850615 on ClinicalTrials.gov Archive Site
  • Self-measured plasma glucose (SMPG) 7-point profile: Post prandial plasma glucose (PPG), overall 2-hour mean (of breakfast, lunch, main evening meal) [ Time Frame: After 18 weeks of randomised treatment ]
  • Self-measured plasma glucose (SMPG) 7-point profile: Prandial plasma glucose (PG) increment, overall 2-hour mean (of breakfast, lunch, main evening meal) [ Time Frame: After 18 weeks of randomised treatment ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 18 ]
  • Number of treatment emergent hypoglycaemic episodes [ Time Frame: Weeks 0-18 ]
  • Number of adverse events [ Time Frame: Weeks 0-18 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: Faster-acting insulin aspart
    Administrated subcutaneously (s.c., under the skin) at each main meal.
    Other Name: NN1218
  • Drug: basal insulin
    Administrated subcutaneously (s.c., under the skin) once daily.
  • Experimental: 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.
    Interventions:
    • Drug: Faster-acting insulin aspart
    • Drug: basal insulin
  • Active Comparator: 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.
    Intervention: Drug: basal insulin
Rodbard HW, Tripathy D, Vidrio Velázquez M, Demissie M, Tamer SC, Piletič 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 Mar 27. doi: 10.1111/dom.12955. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
November 17, 2014
November 17, 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   India,   Mexico,   Romania,   Slovenia,   United States
 
 
NCT01850615
NN1218-4049
2012-005583-10 ( EudraCT Number )
U1111-1137-6242 ( Other Identifier: WHO )
CTRI/2014/01/004289 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP