Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus (DUAL™ VIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501161
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1012 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : January 8, 2016
Actual Primary Completion Date : October 3, 2018
Actual Study Completion Date : October 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin degludec/liraglutide QD + OAD(s) Drug: insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.

Active Comparator: insulin glargine QD + OAD(s) Drug: insulin glargine
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.




Primary Outcome Measures :
  1. Time from randomisation to inadequate glycaemic control and need for treatment intensification [ Time Frame: From visit 3, week 1 until visit 13, week 104 ]

Secondary Outcome Measures :
  1. Time from randomisation to an HbA1c greater than 6.5% at 2 consecutive visits from week 26 [ Time Frame: Week 26, week 38, week 52, week 64, week 78, week 90, week 104 ]
  2. Change from baseline after 26 weeks of treatment in HbA1c [ Time Frame: Week 0, week 26 ]
  3. Change from baseline after 26 weeks of treatment in body weight [ Time Frame: Week 0, week 26 ]
  4. Change from baseline after 26 weeks of treatment in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ]
  5. Change from baseline after 26 weeks of treatment in 9-point Self-measured plasma glucose (SMPG) profile (individual points in the profile) [ Time Frame: Week 0, week 26 ]
  6. Insulin dose after 26 weeks of treatment [ Time Frame: Week 26 ]
  7. Responder (HbA1c less than 7.0%) after 26 weeks of treatment (yes/no) [ Time Frame: Week 26 ]
  8. Responder (HbA1c less than 7.0%) after 104 weeks of treatment (yes/no) [ Time Frame: Week 104 ]
  9. Responder (HbA1c less than or equal to 6.5%) after 26 weeks of treatment (yes/no) [ Time Frame: Week 26 ]
  10. Responder (HbA1c less than or equal to 6.5%) after 104 weeks of treatment (yes/no) [ Time Frame: Week 104 ]
  11. Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment [ Time Frame: Week 0-26 ]
  12. Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment [ Time Frame: Week 0-104 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 greater than or equal to 18 years at the time of signing informed consent - Subjects diagnosed with type 2 diabetes mellitus - HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis - Body mass index greater than or equal to 20 kg/m^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes - Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record) Exclusion Criteria: - Screening calcitonin greater than or equal to 50 ng/L - Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m^2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening - Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - History of pancreatitis (acute or chronic) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening - Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

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): NCT02501161


  Show 138 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Global Clinical Registry GCR, 1452 Novo Nordisk A/S

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02501161     History of Changes
Other Study ID Numbers: NN9068-4228
2014-005639-15 ( EudraCT Number )
U1111-1165-3914 ( Other Identifier: WHO )
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Liraglutide
Insulin, Long-Acting
Xultophy
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists