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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 : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/liraglutide Drug: insulin glargine Drug: insulin aspart Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : October 5, 2016
Actual Study Completion Date : October 5, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IDegLira 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, Week 26 ]
    Change in HbA1c values after 26 weeks of treatment.


Secondary Outcome Measures :
  1. 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.

  2. Change in Body Weight [ Time Frame: Week 0, Week 26 ]
    Change in body weight after 26 weeks of treatment.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age at least 18 years at the time of signing informed consent
  • Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
  • HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
  • Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
  • Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
  • Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
  • Body mass index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
  • Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
  • Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
  • Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
  • Screening calcitonin at least 50 ng/L
  • History of pancreatitis (acute or chronic)
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02420262    
Other Study ID Numbers: NN9068-4185
2014-003621-18 ( EudraCT Number )
U1111-1160-6923 ( Other Identifier: WHO )
REec-2015-1682 ( Registry Identifier: Spanish registry )
First Posted: April 17, 2015    Key Record Dates
Results First Posted: December 7, 2017
Last Update Posted: March 29, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
 Insulin Aspart
Liraglutide
Xultophy
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists