A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT02420262|
Recruitment Status : Completed
First Posted : April 17, 2015
Results First Posted : December 7, 2017
Last Update Posted : December 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: insulin degludec/liraglutide Drug: insulin glargine Drug: insulin aspart||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||506 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||July 26, 2015|
|Primary Completion Date :||October 5, 2016|
|Study Completion Date :||October 5, 2016|
Drug: insulin degludec/liraglutide
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
|Active Comparator: IGlar plus IAsp||
Drug: insulin glargine
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.Drug: insulin aspart
Injected s.c./subcutaneously (under the skin) before each main meal.
- Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, Week 26 ]Change in HbA1c values after 26 weeks of treatment.
- Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes. [ Time Frame: Weeks 0-26 ]Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.
- Change in Body Weight [ Time Frame: Week 0, Week 26 ]Change in body weight after 26 weeks of treatment.
- Responder for HbA1c Below 7.0% [ Time Frame: After 26 weeks of treatment ]Number of subjects with HbA1c below 7% after 26 weeks of treatment.
- Responder for HbA1c Below or Equal to 6.5 % [ Time Frame: After 26 weeks of treatment ]Number of subjects with HbA1c below 6.5% 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): NCT02420262
Show 117 Study Locations
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|