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NCT03078478Completed

A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

Novo Nordisk A/SPhase 3ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
Insulin degludec
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Novo Nordisk A/S
Location
Anniston,Birmingham,Chandler,Fountain Hills,Glendale,Glendale,Glendale,Phoenix,Tucson,Buena Park,Concord,Downey,Duarte,Fresno,La Jolla,Lancaster,Lomita,Los Alamitos,Los Angeles,Moreno Valley,Northridg, Canada,Denmark,Estonia,Germany,Greece,Hungary,Norway,Poland,Puerto Rico,Romania,Serbia,United States
Timeline & enrollment
Phase
Phase 3
Start date
Mar 13, 2017
End date
Mar 04, 2019
Enrollment
1609 participants
Primary outcome

Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)

Summary

This trial is conducted in Europe and North America. The aim of the trial is to compare the
 efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with
 type 2 diabetes mellitus inadequately treated with basal insulin with or without oral
 antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended
 to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03078478
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03078478 through Pure Global AI's free database. This Phase 3 trial is sponsored by Novo Nordisk A/S and is currently Completed. The study focuses on Diabetes,Diabetes Mellitus, Type 2. Target enrollment is 1609 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.