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Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes

NCT01850615 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2019-06-12

Study results available
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Summary

This trial is conducted in Asia, Europe, South America, and the United States of America (USA).

The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.

Conditions

Interventions

DRUG

Faster-acting insulin aspart

Administrated subcutaneously (s.c., under the skin) at each main meal.

DRUG

basal insulin

Administrated subcutaneously (s.c., under the skin) once daily.

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
2013-09-23
Primary Completion
2014-11-17
Completion
2014-11-17

Countries

  • United States
  • Argentina
  • India
  • Mexico
  • Romania
  • Slovenia

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 NCT01850615 on ClinicalTrials.gov