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A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily

NCT01814137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-21

Study results available
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Summary

This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).

Conditions

Interventions

DRUG

insulin degludec/insulin aspart

For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).

DRUG

insulin degludec

For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).

DRUG

insulin aspart

For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted.

DRUG

insulin aspart

For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Algeria
  • Germany
  • Malaysia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814137 on ClinicalTrials.gov