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DiabetesPhase 3NCT01664247

The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

A Phase 3 study testing insulin degludec and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 132 sites in 11 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 Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
insulin degludec and liraglutide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
346 participants
Where
132 sitesin 11 countries
Study dates
1 Oct 2012to 31 Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes
  • Insulin naïve
  • Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID))
  • Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)

Who cannot join

  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
  • Calcitonin equal to or above 50 pg/mL
  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
  • Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)

Trial locations and contacts

132 sites in 11 countries.

132 sites in 11 countries

United States67 sites

  • Novo Nordisk Investigational Site

    Anaheim, California, 92801

  • Novo Nordisk Investigational Site

    Austin, Texas, 78731

  • Novo Nordisk Investigational Site

    Boynton Beach, Florida, 33472

  • Novo Nordisk Investigational Site

    Buckley, Michigan, 49620

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina, 27517

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404-1192

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37411

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri, 63017-3632

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45255

  • Novo Nordisk Investigational Site

    Clearwater, Florida, 33765

  • Novo Nordisk Investigational Site

    Concord, California, 94520

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75231

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75246

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390

  • Novo Nordisk Investigational Site

    Dayton, Ohio, 45439

  • Novo Nordisk Investigational Site

    Decatur, Georgia, 30033

  • Novo Nordisk Investigational Site

    Escondido, California, 92025

  • Novo Nordisk Investigational Site

    Franklin, Ohio, 45005

  • Novo Nordisk Investigational Site

    Fresno, California, 93720

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina, 27408

  • Novo Nordisk Investigational Site

    Greer, South Carolina, 29651

  • Novo Nordisk Investigational Site

    Henderson, Nevada, 89052-2649

  • Novo Nordisk Investigational Site

    Hollywood, Florida, 33021

  • Novo Nordisk Investigational Site

    Houston, Texas, 77030-2703

  • Novo Nordisk Investigational Site

    Humboldt, Tennessee, 38343

  • Novo Nordisk Investigational Site

    Huntington Beach, California, 92648

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland, 20782

  • Novo Nordisk Investigational Site

    Irving, Texas, 75061-2210

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32207

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    La Jolla, California, 92037

  • Novo Nordisk Investigational Site

    Lawrenceville, New Jersey, 08648

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90057

  • Novo Nordisk Investigational Site

    Lubbock, Texas, 79423

  • Novo Nordisk Investigational Site

    Metairie, Louisiana, 70002

  • Novo Nordisk Investigational Site

    Miami, Florida, 33135

  • Novo Nordisk Investigational Site

    Miami, Florida, 33156

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin, 53209

  • Novo Nordisk Investigational Site

    Monterey, California, 93940

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina, 28557

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37212

  • Novo Nordisk Investigational Site

    New Port Richey, Florida, 34652

  • Novo Nordisk Investigational Site

    Newport News, Virginia, 23606

  • Novo Nordisk Investigational Site

    Northport, New York, 11768

  • Novo Nordisk Investigational Site

    Paducah, Kentucky, 42003

  • Novo Nordisk Investigational Site

    Palm Harbor, Florida, 34684

  • Novo Nordisk Investigational Site

    Perry, Georgia, 31069

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19152

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Round Rock, Texas, 78681

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84107

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78224

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina, 29681

  • Novo Nordisk Investigational Site

    Smithtown, New York, 11787

  • Novo Nordisk Investigational Site

    Spokane, Washington, 99218

  • Novo Nordisk Investigational Site

    Spring Valley, California, 91978

  • Novo Nordisk Investigational Site

    Springfield, Illinois, 62711

  • Novo Nordisk Investigational Site

    St. George, Utah, 84790

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77478

  • Novo Nordisk Investigational Site

    Tampa, Florida, 33603

  • Novo Nordisk Investigational Site

    Toms River, New Jersey, 08755-8050

  • Novo Nordisk Investigational Site

    Topeka, Kansas, 66606

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    West Seneca, New York, 14224

Other trials in United States

France11 sites

  • Novo Nordisk Investigational Site

    Bron, 69677

  • Novo Nordisk Investigational Site

    Corbeil-Essonnes, 91106

  • Novo Nordisk Investigational Site

    Le Creusot, 71200

  • Novo Nordisk Investigational Site

    Mérignac, 33700

  • Novo Nordisk Investigational Site

    Nanterre, 92014

  • Novo Nordisk Investigational Site

    Niort, 79021

  • Novo Nordisk Investigational Site

    Pau, 64000

  • Novo Nordisk Investigational Site

    Pointe à Pitre, 97159

  • Novo Nordisk Investigational Site

    Saint-denis de La Reunion, 97405

  • Novo Nordisk Investigational Site

    Saint-Herblain, 44800

  • Novo Nordisk Investigational Site

    Vénissieux, 69200

Other trials in France

Germany9 sites

  • Novo Nordisk Investigational Site

    Berlin, 12163

  • Novo Nordisk Investigational Site

    Falkensee, 14612

  • Novo Nordisk Investigational Site

    Friedrichsthal, 66299

  • Novo Nordisk Investigational Site

    Hamburg, 22607

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679

  • Novo Nordisk Investigational Site

    Kirn, 55606

  • Novo Nordisk Investigational Site

    Ludwigshafen, 67059

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386

  • Novo Nordisk Investigational Site

    Völklingen, 66333

Other trials in Germany

Canada7 sites

  • Novo Nordisk Investigational Site

    Brampton, Ontario, L6T 0G1

  • Novo Nordisk Investigational Site

    Delta, British Columbia, V4K 2K5

  • Novo Nordisk Investigational Site

    London, Ontario, N6P 1A9

  • Novo Nordisk Investigational Site

    Ottawa, Ontario, K1N 1A2

  • Novo Nordisk Investigational Site

    Québec, G3K 2P8

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M5C 2T2

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M9V 4B4

Other trials in Canada

Italy7 sites

  • Novo Nordisk Investigational Site

    Bologna, 40138

  • Novo Nordisk Investigational Site

    Catanzaro, 88100

  • Novo Nordisk Investigational Site

    Milan, 20132

  • Novo Nordisk Investigational Site

    Roma, 00128

  • Novo Nordisk Investigational Site

    Roma, 00133

  • Novo Nordisk Investigational Site

    Roma, 00161

  • Novo Nordisk Investigational Site

    Verona, 37126

Other trials in Italy

Israel6 sites

  • Novo Nordisk Investigational Site

    Beersheba, 84101

  • Novo Nordisk Investigational Site

    Haifa, 31096

  • Novo Nordisk Investigational Site

    Holon, 58100

  • Novo Nordisk Investigational Site

    Jerusalem, 91120

  • Novo Nordisk Investigational Site

    Rishon LeZiyyon, 75650

  • Novo Nordisk Investigational Site

    Tel HaShomer, 52621

Other trials in Israel

South Africa6 sites

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7130

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7700

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4092

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1818

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2198

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape, 6014

Other trials in South Africa

United Kingdom6 sites

  • Novo Nordisk Investigational Site

    Birmingham, B9 5SS

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB

  • Novo Nordisk Investigational Site

    Coventry, CV2 2DX

  • Novo Nordisk Investigational Site

    London, SE1 9RT

  • Novo Nordisk Investigational Site

    London, W6 7HY

  • Novo Nordisk Investigational Site

    Stevenage, SG1 4AB

Other trials in United Kingdom

Ukraine5 sites

  • Novo Nordisk Investigational Site

    Kharkiv, 61000

  • Novo Nordisk Investigational Site

    Kiev, 04114

  • Novo Nordisk Investigational Site

    Lviv, 79010

  • Novo Nordisk Investigational Site

    Ternopil, 46002

  • Novo Nordisk Investigational Site

    Vinnitsa, 21010

Other trials in Ukraine

Serbia4 sites

  • Novo Nordisk Investigational Site

    Belgrade, 11000

  • Novo Nordisk Investigational Site

    Belgrade, 11080

  • Novo Nordisk Investigational Site

    Kragujevac, 34000

  • Novo Nordisk Investigational Site

    Novi Sad, 21000

Other trials in Serbia

United Arab Emirates4 sites

  • Novo Nordisk Investigational Site

    Abu Dhabi, 51900

  • Novo Nordisk Investigational Site

    Dubai, 4545

  • Novo Nordisk Investigational Site

    Ras al-Khaimah, 4727

  • Novo Nordisk Investigational Site

    Sharjah city, 3500

Other trials in United Arab Emirates

About this study

This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.

Being tested
insulin degludec, placebo, liraglutide
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.

  • insulin degludecDrug

    Administered s.c. (under the skin) once daily. Dose individually adjusted.

  • placeboDrug

    Administered s.c. (under the skin) once daily. Dose individually adjusted.

  • liraglutideDrug

    Administered s.c. (under the skin) once daily. Dose: 1.8 mg.

Study groups in NCT01664247
Study groupRoleWhat they receive
IDeg + LiraExperimentalNot described
Receives: Drug: insulin degludec; Drug: liraglutide
Placebo + LiraExperimentalNot described
Receives: Drug: placebo; Drug: liraglutide

What is being measured

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

  1. Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

    Change from baseline in HbA1c after 26 weeks of treatment

    Measured: Week 0, week 26

Secondary outcomes (8)

  1. Change From Baseline in Fasting Plasma Glucose (FPG)

    Change from baseline in FPG after 26 weeks of treatment

    Measured: Week 0, week 26

  2. Number of Responders for HbA1c (Below 7.0 %)

    Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment.

    Measured: After 26 weeks of randomised treatment.

  3. Change From Baseline in Mean Pre-breakfast Measurements Used for Titration

    Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.

    Measured: Week 0, week 26

  4. Change From Baseline in 8-point Profile

    The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.

    Measured: Week 0, week 26

  5. Change From Baseline in Mean of the 8-point Profile

    Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment.

    Measured: Week 0, week 26

  6. Number of Hypoglycaemic Episodes

    Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes.

    Measured: Weeks 0 - 26

  7. Number of Adverse Events

    Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.

    Measured: Weeks 0 - 26

  8. Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)

    Change in subject's quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population.

    Measured: Week 0, week 26

Timeline

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

  1. First posted14 Aug 2012 (estimated)
  2. Study start1 Oct 2012
  3. Primary completion31 Dec 2013
  4. Study completion31 Dec 2013

Resources

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
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01664247
Sponsor's protocol ID
NN1250-3944
Other IDs
2011-004665-32, U1111-1124-6612
Status last verified
Aug 2017
First submitted
10 Aug 2012
Last updated
25 Sep 2017
Data monitoring committee
No

Publications

  • Aroda VR, Bailey TS, Cariou B, Kumar S, Leiter LA, Raskin P, Zacho J, Andersen TH, Philis-Tsimikas A. Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study). Diabetes Obes Metab. 2016 Jul;18(7):663-70. doi: 10.1111/dom.12661. Epub 2016 May 2.

    PubMed 26990378

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 132 sites in 11 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 4 inclusion and 4 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, France, Germany, Canada, Italy and 6 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. 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 20 Apr 2016). 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 From Baseline in Glycosylated Haemoglobin (HbA1c) (%) (time frame: Week 0, 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 NCT01664247, which also lists 1 linked publication.

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 25 Sep 2017.

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