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A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

NCT01880736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2017-02-10

Study results available
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Summary

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.

Conditions

Interventions

DRUG

insulin degludec

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

DRUG

insulin degludec

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

DRUG

insulin degludec

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.

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
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Japan

Study Locations

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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 NCT01880736 on ClinicalTrials.gov