DiabetesPhase 3NCT01617434

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

A Phase 3 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 86 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: liraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 451 participants
Where: 86 sitesin 9 countries
Study dates: Sep 2012to Oct 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

86 sites in 9 countries.

Country

City, postcode or hospital

86 sites in 9 countries

United States31 sites

Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Fresno, California, 93726
Novo Nordisk Investigational Site
Greenfield, Indiana, 46140
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27401-1023
Novo Nordisk Investigational Site
Gurnee, Illinois, 60031
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Kissimmee, Florida, 34741
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Martinsburg, West Virginia, 25401
Novo Nordisk Investigational Site
McMurray, Pennsylvania, 15317
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Methuen, Massachusetts, 01844
Novo Nordisk Investigational Site
Midlothian, Virginia, 23114
Novo Nordisk Investigational Site
Newington, New Hampshire, 03801
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
Novo Nordisk Investigational Site
Phoenix, Arizona, 85020
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Richmond, Virginia, 23219
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84107
Novo Nordisk Investigational Site
San Antonio, Texas, 78215
Novo Nordisk Investigational Site
San Antonio, Texas, 78224
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
San Ramon, California, 94583
Novo Nordisk Investigational Site
Spartanburg, South Carolina, 29303
Novo Nordisk Investigational Site
Sugarland, Texas, 77478
Novo Nordisk Investigational Site
Tustin, California, 92780-7045
Novo Nordisk Investigational Site
Ventura, California, 93003
Novo Nordisk Investigational Site
Walnut Creek, California, 94598

Other trials in United States

Canada11 sites

Novo Nordisk Investigational Site
Burlington, Ontario, L7M 4Y1
Novo Nordisk Investigational Site
Coquitlam, British Columbia, V3K 3P4
Novo Nordisk Investigational Site
Hamilton, Ontario, L8M 1K7
Novo Nordisk Investigational Site
Hamilton, Ontario, L8N 3Z5
Novo Nordisk Investigational Site
Mississauga, Ontario, L5M 2V8
Novo Nordisk Investigational Site
Ottawa, Ontario, K1K 4L2
Novo Nordisk Investigational Site
Smiths Falls, Ontario, K7A 4W8
Novo Nordisk Investigational Site
Thunder Bay, Ontario, P7A 4V7
Novo Nordisk Investigational Site
Toronto, Ontario, M3J 1N2
Novo Nordisk Investigational Site
Vancouver, British Columbia, V5Z 1M9
Novo Nordisk Investigational Site
Westmount, Quebec, H3Z 1E5

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Germany11 sites

Novo Nordisk Investigational Site
Aschaffenburg, 63739
Novo Nordisk Investigational Site
Bad Lauterberg im Harz, 37431
Novo Nordisk Investigational Site
Berlin, 10117
Novo Nordisk Investigational Site
Berlin, 13055
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Gelnhausen, 63571
Novo Nordisk Investigational Site
Gifhorn, 38518
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Mannheim, 68163
Novo Nordisk Investigational Site
Mayen, 56727
Novo Nordisk Investigational Site
Oldenburg, 23758

Other trials in Germany

Netherlands11 sites

Novo Nordisk Investigational Site
Almere Stad, 1315 RA
Novo Nordisk Investigational Site
Breda, 4811 SW
Novo Nordisk Investigational Site
Eindhoven, 5616 GB
Novo Nordisk Investigational Site
Groningen, 9728 NT
Novo Nordisk Investigational Site
Hoogeveen, 7909 AA
Novo Nordisk Investigational Site
Leiden, 2333 ZA
Novo Nordisk Investigational Site
Rotterdam, 3021 HC
Novo Nordisk Investigational Site
Velp, 6883 ES
Novo Nordisk Investigational Site
Venlo, 5912 BL
Novo Nordisk Investigational Site
Zoetermeer, 2724 EK
Novo Nordisk Investigational Site
Zwijndrecht, 3331 LZ

Other trials in Netherlands

India10 sites

Novo Nordisk Investigational Site
Bangalore, Karnataka, 560034
Novo Nordisk Investigational Site
Hyderabad, 600034
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, 452010
Novo Nordisk Investigational Site
Jaipur, Rajasthan, 302006
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700031
Novo Nordisk Investigational Site
Kolkata, 700017
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400012
Novo Nordisk Investigational Site
Rohtak, Haryana, 124001
Novo Nordisk Investigational Site
Thriruvananthapuram, 695 032
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Finland5 sites

Novo Nordisk Investigational Site
Helsinki, FI-00100
Novo Nordisk Investigational Site
Kerava, FI-04200
Novo Nordisk Investigational Site
Tampere, 33520
Novo Nordisk Investigational Site
Turku, FI-20520
Novo Nordisk Investigational Site
Ylitornio, FI-95600

Other trials in Finland

Argentina4 sites

Novo Nordisk Investigational Site
Buenos Aires, C1425AGC
Novo Nordisk Investigational Site
Caba, C1179AAB
Novo Nordisk Investigational Site
Caba, C1180AAX
Novo Nordisk Investigational Site
Córdoba, X5016KEH

Other trials in Argentina

Mexico2 sites

Novo Nordisk Investigational Site
Mexico City, México, D.F., 03800
Novo Nordisk Investigational Site
Pachuca, Hidalgo, 42084

Other trials in Mexico

Serbia1 site

Novo Nordisk Investigational Site
Niš, 18000

Other trials in Serbia

About this study

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: liraglutide, placebo
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liraglutideDrug
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.
placeboDrug
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.

Study groups in NCT01617434
Study group	Role	What they receive
Liraglutide	Experimental	Not described Receives: Drug: liraglutide
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
The estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Measured: Week 0 to Week 26

Secondary outcomes (8)

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
The estimated mean change from baseline in FPG after 26 weeks of treatment.
Measured: Week 0 to Week 26
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.
Measured: Week 0 to Week 26
Change in Body Weight From Baseline to Week 26
The estimated mean change in body weight after 26 weeks of treatment.
Measured: Week 0 to Week 26
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
Measured: At Week 26
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.
Measured: At Week 26
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.
Measured: Week 0 to Week 26 + 7 days follow up
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).
Measured: Week 0 to Week 26 + 7 days follow up
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.
Measured: Week 0 to Week 26 + 7 days follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Oct 2013

First posted12 Jun 2012 (estimated)
Study startSep 2012
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 451 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01617434
Sponsor's protocol ID: NN2211-3917
Other IDs: 2011-002696-41, U1111-1121-9874
Status last verified: Jan 2017
First submitted: 8 Jun 2012
Last updated: 8 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26179619
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.
PubMed 26582052

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01617434
Acronym / sponsor ID: NN2211-3917
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 451 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 12 Jun 2012 (estimated)
Results: Posted 28 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Liraglutide	Experimental	Drug: liraglutide
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutideMaximum 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	Liraglutide
placeboPlacebo 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

Primary outcome

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.

8 secondary outcomes

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Time frame: 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
Change in Body Weight From Baseline to Week 26
Time frame: 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 or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)
Time frame: At Week 26
Number of Adverse Events (AEs) During The Randomised Treatment Period
Time frame: 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
Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period
Time frame: Week 0 to Week 26 + 7 days follow up

Results and safety

Results posted to the registry on 28 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide	226	191
Placebo	225	174

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26

Time frame: Week 0 to Week 26. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	Liraglutide n = 215	Placebo n = 217
Value	-1.30 (1.015)	-0.11 (1.088)

Liraglutide vs Placebo: Mean Difference (Final Values): -1.19 (95% CI -1.39 to -0.99), p <0.0001, Mixed Models Analysis

Population analysed: Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 0 to Week 26 + 7 days follow up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide	11 of 225 (4.9%)	103 of 225 (45.8%)	Not reported
Placebo	7 of 225 (3.1%)	46 of 225 (20.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26179619Ahmann 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 publication: PubMed 26582052Freemantle 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

86 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 86 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada, Germany, Netherlands, India and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 (time frame: Week 0 to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01617434, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.