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Completed Phase 3 Interventional Results available

Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

ClinicalTrials.gov ID: NCT01388361

Public ClinicalTrials.gov record NCT01388361. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 10:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes. Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

Study identification

NCT ID
NCT01388361
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novo Nordisk A/S
Industry
Enrollment
413 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2011 (Type not available)
Primary completion
Jul 2012 (Actual)
Completion
Jul 2012 (Actual)
Last update posted
Mar 6, 2017

2011 – 2012

United States locations

U.S. sites
48
U.S. states
19
U.S. cities
47
Facility City State ZIP Site status
Novo Nordisk Investigational Site Concord California 94520-1926 —
Novo Nordisk Investigational Site La Jolla California 92037 —
Novo Nordisk Investigational Site Lancaster California 93534 —
Novo Nordisk Investigational Site Los Angeles California 90057 —
Novo Nordisk Investigational Site National City California 91950 —
Novo Nordisk Investigational Site Northridge California 91325 —
Novo Nordisk Investigational Site Palm Springs California 92262 —
Novo Nordisk Investigational Site Santa Monica California 90404 —
Novo Nordisk Investigational Site Spring Valley California 91978 —
Novo Nordisk Investigational Site Tarzana California 91356-3551 —
Novo Nordisk Investigational Site Tustin California 92780 —
Novo Nordisk Investigational Site Boynton Beach Florida 33472 —
Novo Nordisk Investigational Site Melbourne Florida 32901 —
Novo Nordisk Investigational Site Miami Florida 33156 —
Novo Nordisk Investigational Site New Port Richey Florida 34652 —
Novo Nordisk Investigational Site Palm Harbor Florida 34684 —
Novo Nordisk Investigational Site West Palm Beach Florida 33401 —
Novo Nordisk Investigational Site Decatur Georgia 30033 —
Novo Nordisk Investigational Site Chicago Illinois 60607 —
Novo Nordisk Investigational Site Evansville Indiana 47714 —
Novo Nordisk Investigational Site Paducah Kentucky 42003 —
Novo Nordisk Investigational Site Metairie Louisiana 70002 —
Novo Nordisk Investigational Site Slidell Louisiana 70461-4231 —
Novo Nordisk Investigational Site North East Maryland 21901 —
Novo Nordisk Investigational Site Rockville Maryland 20852 —
Novo Nordisk Investigational Site Toms River New Jersey 08755-8050 —
Novo Nordisk Investigational Site Northport New York 11768 —
Novo Nordisk Investigational Site Staten Island New York 10301 —
Novo Nordisk Investigational Site Asheboro North Carolina 27203 —
Novo Nordisk Investigational Site Cincinnati Ohio 45245 —
Novo Nordisk Investigational Site Oklahoma City Oklahoma 73103 —
Novo Nordisk Investigational Site Melrose Park Pennsylvania 19027 —
Novo Nordisk Investigational Site Upper Saint Clair Pennsylvania 15241 —
Novo Nordisk Investigational Site East Providence Rhode Island 02914 —
Novo Nordisk Investigational Site Columbia South Carolina 29203 —
Novo Nordisk Investigational Site Greer South Carolina 29651 —
Novo Nordisk Investigational Site Chattanooga Tennessee 37411 —
Novo Nordisk Investigational Site Humboldt Tennessee 38343 —
Novo Nordisk Investigational Site Nashville Tennessee 37203 —
Novo Nordisk Investigational Site Arlington Texas 76014 —
Novo Nordisk Investigational Site Dallas Texas 75230 —
Novo Nordisk Investigational Site Dallas Texas 75246 —
Novo Nordisk Investigational Site Fort Worth Texas 76113 —
Novo Nordisk Investigational Site Irving Texas 75061-2210 —
Novo Nordisk Investigational Site Lubbock Texas 79423 —
Novo Nordisk Investigational Site San Antonio Texas 78215 —
Novo Nordisk Investigational Site Sugar Land Texas 77479 —
Novo Nordisk Investigational Site Milwaukee Wisconsin 53209 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 76 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01388361, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 6, 2017 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01388361 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →