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

January 25, 2017 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1179AAB
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1180AAX
        • Novo Nordisk Investigational Site
      • Córdoba, Argentina, X5016KEH
        • Novo Nordisk Investigational Site
  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Novo Nordisk Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Novo Nordisk Investigational Site
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
        • Novo Nordisk Investigational Site
      • Hamilton, Ontario, Canada, L8M 1K7
        • Novo Nordisk Investigational Site
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Novo Nordisk Investigational Site
      • Mississauga, Ontario, Canada, L5M 2V8
        • Novo Nordisk Investigational Site
      • Ottawa, Ontario, Canada, K1K 4L2
        • Novo Nordisk Investigational Site
      • Smiths Falls, Ontario, Canada, K7A 4W8
        • Novo Nordisk Investigational Site
      • Thunder Bay, Ontario, Canada, P7A 4V7
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M3J 1N2
        • Novo Nordisk Investigational Site
    • Quebec
      • Westmount, Quebec, Canada, H3Z 1E5
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, FI-00100
        • Novo Nordisk Investigational Site
      • Kerava, Finland, FI-04200
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33520
        • Novo Nordisk Investigational Site
      • Turku, Finland, FI-20520
        • Novo Nordisk Investigational Site
      • Ylitornio, Finland, FI-95600
        • Novo Nordisk Investigational Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Novo Nordisk Investigational Site
      • Bad Lauterberg, Germany, 37431
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 10117
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 13055
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Gelnhausen, Germany, 63571
        • Novo Nordisk Investigational Site
      • Gifhorn, Germany, 38518
        • Novo Nordisk Investigational Site
      • Hohenmölsen, Germany, 06679
        • Novo Nordisk Investigational Site
      • Mannheim, Germany, 68163
        • Novo Nordisk Investigational Site
      • Mayen, Germany, 56727
        • Novo Nordisk Investigational Site
      • Oldenburg, Germany, 23758
        • Novo Nordisk Investigational Site
  • India
      • Hyderabad, India, 600034
        • Novo Nordisk Investigational Site
      • Kolkata, India, 700017
        • Novo Nordisk Investigational Site
      • Thriruvananthapuram, India, 695 032
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • Novo Nordisk Investigational Site
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Novo Nordisk Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302006
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkatta, West Bengal, India, 700031
        • Novo Nordisk Investigational Site
  • Mexico
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42084
        • Novo Nordisk Investigational Site
    • México, D.F.
      • Mexico, D.F., México, D.F., Mexico, 03800
        • Novo Nordisk Investigational Site
  • Netherlands
      • Almere, Netherlands, 1315 RA
        • Novo Nordisk Investigational Site
      • Breda, Netherlands, 4811 SW
        • Novo Nordisk Investigational Site
      • Eindhoven, Netherlands, 5616 GB
        • Novo Nordisk Investigational Site
      • Groningen, Netherlands, 9728 NT
        • Novo Nordisk Investigational Site
      • Hoogeveen, Netherlands, 7909 AA
        • Novo Nordisk Investigational Site
      • Leiden, Netherlands, 2333 ZA
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3021 HC
        • Novo Nordisk Investigational Site
      • Velp, Netherlands, 6883 ES
        • Novo Nordisk Investigational Site
      • Venlo, Netherlands, 5912 BL
        • Novo Nordisk Investigational Site
      • Zoetermeer, Netherlands, 2724 EK
        • Novo Nordisk Investigational Site
      • Zwijndrecht, Netherlands, 3331 LZ
        • Novo Nordisk Investigational Site
  • Serbia
      • Nis, Serbia, 18000
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Novo Nordisk Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93726
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • San Mateo, California, United States, 94401
        • Novo Nordisk Investigational Site
      • San Ramon, California, United States, 94583
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780-7045
        • Novo Nordisk Investigational Site
      • Ventura, California, United States, 93003
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Novo Nordisk Investigational Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Novo Nordisk Investigational Site
    • Indiana
      • Greenfield, Indiana, United States, 46140
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Newington, New Hampshire, United States, 03801
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27401-1023
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • McMurray, Pennsylvania, United States, 15317
        • Novo Nordisk Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Novo Nordisk Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78215
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78224
        • Novo Nordisk Investigational Site
      • Sugarland, Texas, United States, 77478
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23219
        • Novo Nordisk Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
    • West Virginia
      • Martinsburg, West Virginia, United States, 25401
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0 to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0 to Week 26
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.
Week 0 to Week 26
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.
Week 0 to Week 26
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
At Week 26
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.
At Week 26
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.
Week 0 to Week 26 + 7 days follow up
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).
Week 0 to Week 26 + 7 days follow up
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.
Week 0 to Week 26 + 7 days follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-3917
  • 2011-002696-41 (EudraCT Number)
  • U1111-1121-9874 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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