The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01617434
First received: June 8, 2012
Last updated: October 22, 2014
Last verified: October 2014

June 8, 2012
October 22, 2014
September 2012
October 2013   (final data collection date for primary outcome measure)
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
The estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Change in HbA1c (glycosylated haemoglobin A1c) from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01617434 on ClinicalTrials.gov Archive Site
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    The estimated mean change from baseline in FPG after 26 weeks of treatment.
  • Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.
  • Change in Body Weight From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    The estimated mean change in body weight after 26 weeks of treatment.
  • Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target) [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment
  • Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target) [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.
  • Number of Adverse Events (AEs) During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
    An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.
  • Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
    A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL).
  • Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
    Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.
  • Change in fasting plasma glucose (FPG) from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change in 7-point self-measured plasma glucose from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change in body weight from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of subjects achieving HbA1c below 7.0% (American Diabetes Association (ADA) target) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events (AE) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of subjects with minor hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of subjects with severe hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.

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: liraglutide
    Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
  • Drug: placebo
    Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
  • Experimental: Liraglutide
    Intervention: Drug: liraglutide
  • Placebo Comparator: Placebo
    Intervention: 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
451
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
  • HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
  • Body mass index (BMI) 20-45 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
  • Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
  • Impaired liver or renal function
  • Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
  • Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
  • Known or suspected abuse of alcohol or narcotics
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Mexico,   India,   Germany,   Finland,   Canada,   Argentina,   Serbia,   United States
 
NCT01617434
NN2211-3917, 2011-002696-41, U1111-1121-9874
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
October 2014

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