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)
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|ClinicalTrials.gov Identifier: NCT01618162|
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : February 17, 2017
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: insulin degludec/liraglutide Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||435 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||August 29, 2012|
|Primary Completion Date :||October 23, 2013|
|Study Completion Date :||October 23, 2013|
|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.
- 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.
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): NCT01618162
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|