Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes (DUAL™ I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01336023
First received: April 13, 2011
Last updated: January 6, 2014
Last verified: January 2014

April 13, 2011
January 6, 2014
May 2011
May 2012   (final data collection date for primary outcome measure)
Mean change from baseline in HbA1c (glycosylated haemoglobin) at week 26 [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01336023 on ClinicalTrials.gov Archive Site
  • Mean change from baseline in body weight at week 26 [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
  • Change from baseline in incremental area under the curve 0-4h (iAUC0-4h) derived from the glucose concentration profile during meal test [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Mean actual daily insulin dose [ 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 ]
  • Number of hypoglycaemic episodes [ Time Frame: weeks 0-26 ] [ Designated as safety issue: No ]
  • Change from baseline in incremental area under the curve 0-4h (iAUC0-4h) derived from the glucose concentration profile during meal test [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
  • Daily insulin dose [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes
A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.

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
    Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily.
  • Drug: insulin degludec
    Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.
  • Drug: liraglutide
    Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.
  • Experimental: IDeg
    Intervention: Drug: insulin degludec
  • Experimental: IDegLira
    Intervention: Drug: insulin degludec/liraglutide
  • Experimental: Lira
    Intervention: Drug: liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1663
November 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
  • Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)
  • Subjects on stable dose of 1-2 OADs (metformin [at least 1500 mg or max tolerated dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least 30 mg]) for at least 90 days prior to screening
  • Body Mass Index (BMI) maximum 40 kg/m^2

Exclusion Criteria:

  • Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)
  • Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial
  • Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
  • Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
  • Screening calcitonin at least 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 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
  • Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)
  • Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
  • 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
United Kingdom,   Taiwan,   Spain,   South Africa,   Slovakia,   Singapore,   Russian Federation,   Mexico,   Malaysia,   Italy,   Ireland,   Thailand,   Hungary,   Germany,   Finland,   Canada,   Australia,   India,   United States,   Puerto Rico
 
NCT01336023
NN9068-3697, U1111-1119-1174, 2010-021560-15
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
January 2014

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