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The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy (DUAL™IV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01618162
First Posted: June 13, 2012
Last Update Posted: April 26, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
June 11, 2012
June 13, 2012
December 20, 2016
February 17, 2017
April 26, 2017
August 2012
October 2013   (Final data collection date for primary outcome measure)
Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]
Change in HbA1c from baseline to 26 weeks.
Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]
Complete list of historical versions of study NCT01618162 on ClinicalTrials.gov Archive Site
  • Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) [ Time Frame: Week 26 ]
    Percentage of subjects having HbA1c below 7% at week 26.
  • Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) [ Time Frame: Week 26 ]
    Percentage of subjects having HbA1c below 6.5% at week 26
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
    Change from baseline in FPG at week 26.
  • Change From Baseline in Body Weight [ Time Frame: Week 0, week 26 ]
    Change from baseline in body weight at week 26.
  • Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes [ Time Frame: After 26 weeks of treatment ]

    An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.

    Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.

    Minor hypoglycaemic episodes were defined as:

    1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.
    2. Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).

    Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

    Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).

  • Number of Adverse Events (AEs) [ Time Frame: After 26 weeks of treatment ]
    An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.
  • Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) [ Time Frame: Week 26 ]
  • Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) [ Time Frame: Week 26 ]
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
  • Change From Baseline in Body Weight [ Time Frame: Week 0, week 26 ]
  • Number of severe or minor hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ]
  • Number of Adverse Events (AEs) [ Time Frame: After 26 weeks of treatment ]
Not Provided
Not Provided
 
The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec/liraglutide
    Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
  • Drug: placebo
    Injected subcutaneously (under the skin) once daily.
  • Experimental: Insulin degludec/liraglutide
    Intervention: Drug: insulin degludec/liraglutide
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
435
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus
  • HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
  • Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
  • Body Mass Index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

  • Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)
  • Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
  • Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
  • Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
  • Screening calcitonin above or equal to 50 ng/l
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  • Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures
  • Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
  • Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus),neurological, genitourinary or haematological system that in the opinion of the Investigator,may confound the results of the trial or pose additional risk in administering trial product
  • History of chronic pancreatitis or idiopathic acute pancreatitis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Germany,   India,   Israel,   Puerto Rico,   Turkey,   United States
Macedonia, The Former Yugoslav Republic of
 
NCT01618162
NN9068-3951
2012-000140-97 ( EudraCT Number )
U1111-1126-9776 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP