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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01617434
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : October 28, 2014
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
Study Start Date : September 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Liraglutide 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.
Placebo Comparator: Placebo 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]
    The estimated mean change from baseline in HbA1c after 26 weeks of treatment.


Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]
    The estimated mean change from baseline in FPG after 26 weeks of treatment.

  2. Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]
    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.

  3. Change in Body Weight From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]
    The estimated mean change in body weight after 26 weeks of treatment.

  4. Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target) [ Time Frame: At Week 26 ]
    Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment

  5. Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target) [ Time Frame: At Week 26 ]
    Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.

  6. Number of Adverse Events (AEs) During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    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.

  7. Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    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).

  8. Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617434


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01617434    
Other Study ID Numbers: NN2211-3917
2011-002696-41 ( EudraCT Number )
U1111-1121-9874 ( Other Identifier: WHO )
First Posted: June 12, 2012    Key Record Dates
Results First Posted: October 28, 2014
Last Update Posted: March 8, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists