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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 - Trial NCT03078478

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.

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NCT03078478
Phase 3
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT03078478
View on ClinicalTrials.gov
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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

Study Focus

Insulin degludec

Interventional

drug

Sponsor & Location

Novo Nordisk A/S

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 3

Mar 13, 2017

Mar 04, 2019

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 mellitus
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT03078478

Non-Device Trial