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Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes (onset® 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01819129
First received: March 21, 2013
Last updated: May 9, 2017
Last verified: May 2017
March 21, 2013
May 9, 2017
September 9, 2013
January 22, 2015   (Final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: Week 0, week 26 ]
Same as current
Complete list of historical versions of study NCT01819129 on ClinicalTrials.gov Archive Site
  • Change from baseline in 2-hour PPG increment (meal test) [ Time Frame: Week 0, week 26 ]
  • Number of treatment emergent confirmed hypoglycaemic episodes [ Time Frame: From week 0 to week 26 ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: Faster-acting insulin aspart
    Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.
  • Drug: Insulin aspart
    Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.
  • Drug: Insulin glargine
    Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.
  • Experimental: Faster-acting insulin aspart (FIAsp)
    Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.
    Interventions:
    • Drug: Faster-acting insulin aspart
    • Drug: Insulin glargine
  • Active Comparator: Insulin aspart
    Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.
    Interventions:
    • Drug: Insulin aspart
    • Drug: Insulin glargine
Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7):951-957. doi: 10.2337/dc16-1770. Epub 2017 May 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
881
January 22, 2015
January 22, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1)
  • Treated with basal insulin for at least 6 months prior to screening (visit 1)
  • Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine 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 DPP-IV (dipeptidyl peptidase-4) 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. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1)
  • Body mass index (BMI) equal to or below 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 consecutive treatment) and not 3 months prior to the screening visit (visit 1)
  • Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1)
  • Recurrent severe hypoglycaemia (more than 1 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)
  • Cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as: stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris or coronary arterial bypass graft or angioplasty
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Croatia,   India,   Israel,   Puerto Rico,   Russian Federation,   Serbia,   Slovakia,   United Kingdom,   United States
 
 
NCT01819129
NN1218-3853
2010-024051-93 ( EudraCT Number )
U1111-1118-2509 ( Other Identifier: WHO )
CTRI/2014/01/004285 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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
May 2017

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