The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy (DUAL™IV)
|Diabetes Diabetes Mellitus, Type 2||Drug: insulin degludec/liraglutide Drug: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy|
- Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]Change in HbA1c from baseline to 26 weeks.
- Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) [ Time Frame: Week 26 ]Percentage of subjects having HbA1c below 7% at week 26.
- Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) [ Time Frame: Week 26 ]Percentage of subjects having HbA1c below 6.5% at week 26
- Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]Change from baseline in FPG at week 26.
- Change From Baseline in Body Weight [ Time Frame: Week 0, week 26 ]Change from baseline in body weight at week 26.
- Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes [ Time Frame: After 26 weeks of treatment ]
An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.
Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.
Minor hypoglycaemic episodes were defined as:
- An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.
- Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).
Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).
- Number of Adverse Events (AEs) [ Time Frame: After 26 weeks of treatment ]An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.
|Study Start Date:||August 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|Experimental: Insulin degludec/liraglutide||
Drug: insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
|Placebo Comparator: Placebo||
Injected subcutaneously (under the skin) once daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618162
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|