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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01819129
First received: March 21, 2013
Last updated: October 14, 2014
Last verified: October 2014

March 21, 2013
October 14, 2014
September 2013
January 2015   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Number of treatment emergent confirmed hypoglycaemic episodes [ Time Frame: From week 0 to week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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: Insulin aspart (FIAsp)
    Interventions:
    • Drug: Faster-acting insulin aspart
    • Drug: insulin glargine
  • Active Comparator: Insulin aspart
    Interventions:
    • Drug: insulin aspart
    • Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
676
January 2015
January 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Slovakia,   Serbia,   Russian Federation,   Israel,   India,   Croatia,   Canada,   United Kingdom,   United States,   Puerto Rico
 
NCT01819129
NN1218-3853, 2010-024051-93, U1111-1118-2509, CTRI/2014/01/004285
No
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
October 2014

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