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Trial record 1 of 1 for:    ideglira, basal-bolus
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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02420262
First received: April 8, 2015
Last updated: June 7, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/liraglutide Drug: insulin glargine Drug: insulin aspart Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, Week 26 ]

Secondary Outcome Measures:
  • Number of treatment emergent severe hypoglycaemic episodes [ Time Frame: Weeks 0-26 ]
  • Number of blood glucose confirmed symptomatic hypoglycaemic episodes [ Time Frame: Weeks 0-26 ]
  • Change in body weight [ Time Frame: Week 0, Week 26 ]
  • Responder for HbA1c below 7.0% [ Time Frame: After 26 weeks of treatment ]
  • Responder for HbA1c below or equal to 6.5 % [ Time Frame: After 26 weeks of treatment ]

Enrollment: 506
Actual Study Start Date: July 26, 2015
Study Completion Date: October 5, 2016
Primary Completion Date: October 5, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02420262

  Show 117 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02420262     History of Changes
Other Study ID Numbers: NN9068-4185
2014-003621-18 ( EudraCT Number )
U1111-1160-6923 ( Other Identifier: WHO )
REec-2015-1682 ( Registry Identifier: Spanish registry )
Study First Received: April 8, 2015
Last Updated: June 7, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Liraglutide
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 26, 2017