A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily
Launched by NOVO NORDISK A/S · Mar 18, 2013
Trial Information
Current as of May 05, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941 (NCT01680341), by central laboratory
- Exclusion Criteria:
- • Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
- • Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
- • Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Anaheim, California, United States
Rehlingen Siersburg, , Germany
St. Ingbert, , Germany
Spring Valley, California, United States
Tacoma, Washington, United States
Waltham, Massachusetts, United States
Olympia, Washington, United States
Plantation, Florida, United States
Lawrenceville, New Jersey, United States
Dallas, Texas, United States
Münster, , Germany
Kota Bharu, Kelantan, , Malaysia
Greenbrae, California, United States
Albany, New York, United States
Neuwied, , Germany
Goodyear, Arizona, United States
Avon, Illinois, United States
Gaziantep, , Turkey
Bradenton, Florida, United States
Buckley, Michigan, United States
Toms River, New Jersey, United States
Slidell, Louisiana, United States
Kissimmee, Florida, United States
Nashua, New Hampshire, United States
Denizli, , Turkey
Selangor, , Malaysia
Algiers, , Algeria
Oran, , Algeria
San Diego, California, United States
Crystal Lake, Illinois, United States
Indianapolis, Indiana, United States
Myrtle Beach, South Carolina, United States
Hatay, , Turkey
Phoenix, Arizona, United States
Istanbul, , Turkey
Fort Worth, Texas, United States
Tizi Ouzou, , Algeria
Erdmannhausen, , Germany
Kenosha, Wisconsin, United States
Patients applied
Trial Officials
Global Clinical Registry (GCR, 1452)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials