The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III)
|ClinicalTrials.gov Identifier: NCT01676116|
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : July 9, 2018
Last Update Posted : July 9, 2018
This trial is conducted in Europe, Oceania and the United States of America (USA).
The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: insulin degludec/liraglutide Drug: liraglutide Drug: exenatide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||438 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)|
|Actual Study Start Date :||August 29, 2012|
|Actual Primary Completion Date :||March 11, 2014|
|Actual Study Completion Date :||March 11, 2014|
|Experimental: Insulin degludec/liraglutide + OADs||
Drug: insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.
|Active Comparator: Liraglutide or exenatide + OADs||
Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
- Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2) [ Time Frame: Week 0, week 26 ]
- Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) [ Time Frame: Week 26 ]Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment.
- Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) [ Time Frame: Week 26 ]Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol).
- Change From Baseline in Body Weight [ Time Frame: Week 0, week 26 ]Mean change in body weight after 26 weeks of treatment.
- Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment.
- Number of Severe or Minor Hypoglycaemic Episodes [ Time Frame: After 26 weeks of treatment ]Rate (events per 100 patient years of exposure) of treatment-emergent confirmed hypoglycaemic episodes. The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes. Severe hypoglycaemia was categorised as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or PG <3.1 mmol/L (56 mg/dL), and which was handled by the subject himself/herself, or any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or PG value <3.1 mmol/L (56 mg/dL).
- Number of Adverse Events (AEs) [ Time Frame: After 26 weeks of treatment ]Rate (events per 100 exposure years) of treatment-emergent adverse events (an event that had onset date (or an increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment) which occurred during the 26 weeks of treatment.
- Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D) [ Time Frame: Week 0, week 26 ]The patient related outcome is calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total score are later transformed to a 0-100 scale for analysis. The mean change in scores from baseline to 26 weeks for all the individual sub domains and total scores are presented here.
- Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ). [ Time Frame: Week 0, week 26 ]Mean change in diabetes treatment satisfaction questionnaire (DTSQs) scores from baseline. The scores ranged from 0 to 6. Higher total score on a 0-6 point scale indicates a general higher treatment satisfaction, whereas higher score on perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia indicate that blood glucose levels are out of the target range.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676116
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|