The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01664247
First received: August 10, 2012
Last updated: March 12, 2014
Last verified: March 2014

August 10, 2012
March 12, 2014
October 2012
December 2013   (final data collection date for primary outcome measure)
Change from baseline in glycosylated haemoglobin (HbA1c) (%) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01664247 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of responders for HbA1c (below 7.0 %) [ Time Frame: After 26 weeks of randomised treatment ] [ Designated as safety issue: No ]
  • Change from baseline in mean pre-breakfast measurements used for titration [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in 8-point profile [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in mean of the 8-point profile [ 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 ]
  • Number of adverse events [ Time Frame: Weeks 0 - 26 ] [ Designated as safety issue: No ]
  • Change from baseline in patient reported health-related quality of life using the Short-Form 36 Health Survey version 2 (SF-36®v2) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (lira) and metformin in subjects with type 2 diabetes qualifying for treatment intensification.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec
    Administered s.c. (under the skin) once daily. Dose individually adjusted.
  • Drug: liraglutide
    Administered s.c. (under the skin) once daily. Dose: 1.8 mg.
  • Drug: placebo
    Administered s.c. (under the skin) once daily. Dose individually adjusted.
  • Experimental: IDeg
    Interventions:
    • Drug: insulin degludec
    • Drug: liraglutide
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
346
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Insulin naïve
  • Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID))
  • Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)

Exclusion Criteria:

  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
  • Calcitonin equal to or above 50 pg/mL
  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
  • Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United Arab Emirates,   Ukraine,   South Africa,   Italy,   Israel,   Germany,   France,   Canada,   Serbia,   United States
 
NCT01664247
NN1250-3944, 2011-004665-32, U1111-1124-6612
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Kathleen Stolpe 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