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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

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ClinicalTrials.gov Identifier: NCT01713530
Recruitment Status : Completed
First Posted : October 24, 2012
Results First Posted : November 17, 2015
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/insulin aspart Drug: insulin degludec Drug: insulin aspart Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2013
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: IDegAsp BID+/-OADs Drug: insulin degludec/insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
Experimental: IDeg OD plus IAsp +/-OADs 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.


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in HbA1c (%) [ Time Frame: Week 0, week 26 ]
    Change from baseline in HbA1c (%) after 26 weeks of treatment


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
    Change from baseline in FPG after 26 weeks of treatment

  2. 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))

  3. 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


  4. 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.

  5. 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713530


  Show 51 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01713530     History of Changes
Other Study ID Numbers: NN5401-3996
2012-002346-20 ( EudraCT Number )
U1111-1130-7135 ( Other Identifier: WHO )
First Posted: October 24, 2012    Key Record Dates
Results First Posted: November 17, 2015
Last Update Posted: March 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs