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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:
ClinicalTrials.gov Identifier:
NCT01713530
First Posted: October 24, 2012
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
October 22, 2012
October 24, 2012
October 16, 2015
November 17, 2015
March 17, 2017
February 2013
January 2014   (Final data collection date for primary outcome measure)
Change From Baseline in HbA1c (%) [ Time Frame: Week 0, week 26 ]
Change from baseline in HbA1c (%) after 26 weeks of treatment
Change From Baseline in HbA1c (%) [ Time Frame: Week 0, week 26 ]
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 ]
    Change from baseline in FPG after 26 weeks of treatment
  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During Weeks 0-26 ]
    According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL))
  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During Weeks 0-26 ]

    According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:

    Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia

  • Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 ]
    Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
  • Incidence of Treatment Emergent Adverse Events (TEAE) [ Time Frame: Weeks 0-26 ]
    A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 ]
  • Number of treatment emergent hypoglycaemic episodes. Number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes [ Time Frame: Weeks 0-26 ]
  • Incidence of Treatment Emergent Adverse Events (TEAE) [ Time Frame: Weeks 0-26 ]
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
Intervention Model: Parallel Assignment
Masking: None (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
Rodbard HW, Cariou B, Pieber TR, Endahl LA, Zacho J, Cooper JG. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab. 2016 Mar;18(3):274-80. doi: 10.1111/dom.12609. Epub 2016 Jan 11.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Austria,   France,   Norway,   United States
 
 
NCT01713530
NN5401-3996
2012-002346-20 ( EudraCT Number )
U1111-1130-7135 ( Other Identifier: WHO )
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
February 2017

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