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A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes (DUAL™ II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01392573
First received: July 7, 2011
Last updated: April 26, 2017
Last verified: April 2017
  Purpose
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/liraglutide Drug: insulin degludec Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]
    Observed mean change from baseline in HbA1c after 26 Weeks of treatment.


Secondary Outcome Measures:
  • Change in Body Weight [ Time Frame: Week 0, week 26 ]
    Observed mean change from baseline in body weight after 26 Weeks of treatment.


Enrollment: 413
Actual Study Start Date: November 28, 2011
Study Completion Date: October 4, 2012
Primary Completion Date: October 1, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegLira + metformin
IDegLira was injected subcutaneously once daily for 26 weeks.
Drug: insulin degludec/liraglutide
IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.
Experimental: IDeg + metformin
IDeg was injected subcutaneously once daily for 26 weeks.
Drug: insulin degludec
IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.

  Eligibility

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

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
  • Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
  • BMI (Body Mass Index) more than or equal to 27 kg/m^2

Exclusion Criteria:

  • Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
  • Impaired liver function
  • Impaired renal function
  • Screening calcitonin equal to or above 50 ng/l
  • Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
  • Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
  • Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)
  • Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  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: NCT01392573

  Show 86 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:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01392573     History of Changes
Other Study ID Numbers: NN9068-3912
2011-002336-72 ( EudraCT Number )
U1111-1121-4897 ( Other Identifier: WHO )
Study First Received: July 7, 2011
Results First Received: November 23, 2016
Last Updated: April 26, 2017

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

ClinicalTrials.gov processed this record on June 22, 2017