A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification
NCT02906917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 532
Last updated 2019-11-13
Summary
Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.
Conditions
- Diabetes
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Insulin degludec/insulin aspart
Administered subcutaneously (s.c. under the skin) once daily.
- DRUG
-
Insulin glargine
Administered subcutaneously (s.c. under the skin) once daily.
- DRUG
-
Insulin aspart
Administered subcutaneously (s.c. under the skin) once daily.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-20
- Primary Completion
- 2017-08-31
- Completion
- 2017-12-24
- FDA Drug
- Yes
Countries
- United States
- Algeria
- Czechia
- India
- Russia
- Serbia
- Turkey (Türkiye)
Study Locations
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