A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V)
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|ClinicalTrials.gov Identifier: NCT01952145|
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : January 20, 2017
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: insulin degludec/liraglutide Drug: insulin glargine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||557 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch)|
|Actual Study Start Date :||September 20, 2013|
|Actual Primary Completion Date :||November 4, 2014|
|Actual Study Completion Date :||November 4, 2014|
|Experimental: Insulin degludec/liraglutide OD plus metformin||
Drug: insulin degludec/liraglutide
Insulin degludec/liraglutide is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.
|Active Comparator: Insulin glargine OD plus metformin||
Drug: insulin glargine
Insulin glargine is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]Change from baseline in HbA1c after 26 weeks of treatment
- Change From Baseline in Body Weight [ Time Frame: Week 0, week 26 ]Change from baseline in body weight after 26 weeks of treatment
- Number of Treatment Emergent Confirmed Hypoglycaemic Episodes [ Time Frame: During 26 weeks of treatment ]Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952145
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|