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 18, 2016
Last verified: March 2016

August 10, 2012
March 18, 2016
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 ]
Change from baseline in HbA1c after 26 weeks of treatment
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
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 ]
    Change from baseline in FPG after 26 weeks of treatment
  • Number of Responders for HbA1c (Below 7.0 %) [ Time Frame: After 26 weeks of randomised treatment. ] [ Designated as safety issue: No ]
    Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment.
  • 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 after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
  • Change From Baseline in 8-point Profile [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
    The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
  • Change From Baseline in Mean of the 8-point Profile [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
    Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment.
  • Number of Hypoglycaemic Episodes [ Time Frame: Weeks 0 - 26 ] [ Designated as safety issue: No ]
    Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes.
  • Number of Adverse Events [ Time Frame: Weeks 0 - 26 ] [ Designated as safety issue: No ]
    Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
  • 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 ]
    Change in subject's quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population.
  • 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 ]
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 (at least 1500 mg daily or maximum tolerated dose) 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: placebo
    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.
  • Experimental: IDeg + Lira
    Interventions:
    • Drug: insulin degludec
    • Drug: liraglutide
  • Experimental: Placebo + Lira
    Interventions:
    • Drug: placebo
    • 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
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   Israel,   Italy,   Serbia,   South Africa,   Ukraine,   United Arab Emirates,   United Kingdom
 
NCT01664247
NN1250-3944, 2011-004665-32, U1111-1124-6612
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 2016

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