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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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
liraglutide
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liraglutide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
The estimated mean change from baseline in HbA1c after 26 weeks of treatment.

Secondary Outcome Measures

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
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
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
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)
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)
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
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
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
Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.

Full Information

First Posted
June 8, 2012
Last Updated
January 25, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01617434
Brief Title
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
Description
The estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Time Frame
Week 0 to Week 26
Secondary Outcome Measure Information:
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Description
The estimated mean change from baseline in FPG after 26 weeks of treatment.
Time Frame
Week 0 to Week 26
Title
Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26
Description
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.
Time Frame
Week 0 to Week 26
Title
Change in Body Weight From Baseline to Week 26
Description
The estimated mean change in body weight after 26 weeks of treatment.
Time Frame
Week 0 to Week 26
Title
Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)
Description
Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment
Time Frame
At Week 26
Title
Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)
Description
Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.
Time Frame
At Week 26
Title
Number of Adverse Events (AEs) During The Randomised Treatment Period
Description
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.
Time Frame
Week 0 to Week 26 + 7 days follow up
Title
Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period
Description
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).
Time Frame
Week 0 to Week 26 + 7 days follow up
Title
Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period
Description
Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.
Time Frame
Week 0 to Week 26 + 7 days follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780-7045
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newington
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401-1023
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
McMurray
State/Province
Pennsylvania
ZIP/Postal Code
15317
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugarland
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Martinsburg
State/Province
West Virginia
ZIP/Postal Code
25401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1179AAB
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Córdoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1K 4L2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Smiths Falls
State/Province
Ontario
ZIP/Postal Code
K7A 4W8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7A 4V7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 1N2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Westmount
State/Province
Quebec
ZIP/Postal Code
H3Z 1E5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
FI-00100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kerava
ZIP/Postal Code
FI-04200
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Ylitornio
ZIP/Postal Code
FI-95600
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bad Lauterberg
ZIP/Postal Code
37431
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Friedrichsthal
ZIP/Postal Code
66299
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Gelnhausen
ZIP/Postal Code
63571
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Gifhorn
ZIP/Postal Code
38518
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hohenmölsen
ZIP/Postal Code
06679
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Mannheim
ZIP/Postal Code
68163
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Mayen
ZIP/Postal Code
56727
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Oldenburg
ZIP/Postal Code
23758
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302006
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkatta
State/Province
West Bengal
ZIP/Postal Code
700031
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
ZIP/Postal Code
600034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
ZIP/Postal Code
700017
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Thriruvananthapuram
ZIP/Postal Code
695 032
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pachuca
State/Province
Hidalgo
ZIP/Postal Code
42084
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Mexico, D.F.
State/Province
México, D.F.
ZIP/Postal Code
03800
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Almere
ZIP/Postal Code
1315 RA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Breda
ZIP/Postal Code
4811 SW
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Eindhoven
ZIP/Postal Code
5616 GB
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Velp
ZIP/Postal Code
6883 ES
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Zoetermeer
ZIP/Postal Code
2724 EK
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia

12. IPD Sharing Statement

Citations:
PubMed Identifier
26179619
Citation
Ahmann A, Rodbard HW, Rosenstock J, Lahtela JT, de Loredo L, Tornoe K, Boopalan A, Nauck MA; NN2211-3917 Study Group. Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2015 Nov;17(11):1056-64. doi: 10.1111/dom.12539. Epub 2015 Sep 10.
Results Reference
result
PubMed Identifier
26582052
Citation
Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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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

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