A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01713530
First received: October 22, 2012
Last updated: January 24, 2014
Last verified: January 2014

October 22, 2012
January 24, 2014
February 2013
January 2014   (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 NCT01713530 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent hypoglycaemic episodes [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent hypoglycaemic episodes. Number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events (TEAE) [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec/insulin aspart
    Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
  • Drug: insulin degludec
    Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
  • Drug: insulin aspart
    Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.
  • Experimental: IDegAsp BID +/- OADs
    Intervention: Drug: insulin degludec/insulin aspart
  • Experimental: IDeg OD plus IAsp +/- OADs
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
274
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
  • Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
  • HbA1c 7.0% - 10.0%
  • Body mass index (BMI) less than or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Chronic disorder or disease which might jeopardise safety or compliance
  • Malignant neoplasms
  • Recurrent severe hypoglycaemia
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Austria,   Algeria,   Norway,   United States
 
NCT01713530
NN5401-3996, 2012-002346-20, U1111-1130-7135
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
January 2014

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