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Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes

NCT01819129 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 881

Last updated 2019-01-30

Study results available
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Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.

Conditions

Interventions

DRUG

Faster-acting insulin aspart

Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.

DRUG

Insulin aspart

Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.

DRUG

Insulin glargine

Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-09
Primary Completion
2015-01-22
Completion
2015-01-22
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Croatia
  • India
  • Israel
  • Puerto Rico
  • Russia
  • Serbia
  • Slovakia
  • United Kingdom

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 NCT01819129 on ClinicalTrials.gov