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Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

NCT01519674 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 582

Last updated 2017-02-24

Study results available
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Summary

This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)).

The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.

Conditions

Interventions

DRUG

biphasic insulin aspart 30

BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.

DRUG

biphasic insulin aspart 30

BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.

DRUG

sitagliptin

Subjects will continue on their pre-trial sitagliptin treatment.

DRUG

metformin

Subjects will continue on their pre-trial metformin treatment.

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
2012-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Argentina
  • Australia
  • Brazil
  • Greece
  • India
  • Malaysia
  • Portugal
  • South Korea
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
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 NCT01519674 on ClinicalTrials.gov