The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01676116
First received: August 28, 2012
Last updated: March 11, 2014
Last verified: March 2014

August 28, 2012
March 11, 2014
August 2012
March 2014   (final data collection date for primary outcome measure)
Change in glycosylated haemoglobin (HbA1c) from baseline (randomisation, Visit 2) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01676116 on ClinicalTrials.gov Archive Site
  • Responders achieving pre-defined target: HbA1c below 7.0% (53 mmol/mol) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Responders achieving pre-defined target: HbA1c below or equal to 6.5% (48 mmol/mol) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of severe or minor hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of adverse events (AEs) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in patient reported outcomes (PROs) based on the treatment related impact measure - diabetes (TRIM-D) and diabetes treatment satisfaction questionnaire (DTSQ) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy
The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)

This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec/liraglutide
    Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.
  • Drug: liraglutide
    Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
  • Drug: exenatide
    Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
  • Experimental: Insulin degludec/liraglutide + OADs
    Intervention: Drug: insulin degludec/liraglutide
  • Active Comparator: Liraglutide or exenatide + OADs
    Interventions:
    • Drug: liraglutide
    • Drug: exenatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
438
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus
  • Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
  • Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
  • BMI (body mass index) equal to or below 40 kg/m^2

Exclusion Criteria:

  • Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
  • Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
  • 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 equal to or above 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 clinically 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 products
  • History of chronic pancreatitis or idiopathic acute pancreatitis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   France,   Australia,   Slovakia,   United States
 
NCT01676116
NN9068-3851, 2012-000209-63, U1111-1127-1321
No
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 2014

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