A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes (DUAL™ II)
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|ClinicalTrials.gov Identifier: NCT01392573|
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : January 20, 2017
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: insulin degludec/liraglutide Drug: insulin degludec||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||413 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes|
|Actual Study Start Date :||November 28, 2011|
|Actual Primary Completion Date :||October 1, 2012|
|Actual Study Completion Date :||October 4, 2012|
Experimental: IDegLira + metformin
IDegLira was injected subcutaneously once daily for 26 weeks.
Drug: insulin degludec/liraglutide
IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.
Experimental: IDeg + metformin
IDeg was injected subcutaneously once daily for 26 weeks.
Drug: insulin degludec
IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]Observed mean change from baseline in HbA1c after 26 Weeks of treatment.
- Change in Body Weight [ Time Frame: Week 0, week 26 ]Observed mean change from baseline in body weight after 26 Weeks of treatment.
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): NCT01392573
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|