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Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen

NCT01165684 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2017-02-17

Study results available
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Summary

This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.

Conditions

Interventions

DRUG

insulin aspart

Insulin aspart added stepwise according to the largest meal following an evaluation of HbA1c. Doses individually adjusted.

DRUG

insulin aspart

Insulin aspart added before each main meal. Doses individually adjusted.

DRUG

insulin detemir

Insulin detemir as basal insulin, adminstered once daily. Doses 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
2010-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • France
  • North Macedonia
  • Slovenia

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 NCT01165684 on ClinicalTrials.gov