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Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

NCT ID: NCT02461589

Last Updated: 2019-07-31

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

706 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-21

Study Completion Date

2016-10-13

Brief Summary

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This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Semaglutide 0.05 mg/day

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Liraglutide 0.3 mg/day

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Placebo 50 µL

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily.

Semaglutide 0.05/0.1 mg/day

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Liraglutide 0.3/0.6 mg/day

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Placebo 50/100 µL

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily.

Semaglutide 0.05/0.1/0.2 mg/day

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Liraglutide 0.3/0.6/1.2 mg/day

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Placebo 50/100/200 µL

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily.

Semaglutide 0.05/0.1/0.2/0.3 mg/day

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Liraglutide 0.3/0.6/1.2/1.8 mg/day

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Placebo 50/100/200/300 µL

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily.

Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Interventions

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semaglutide

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Intervention Type DRUG

liraglutide

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Intervention Type DRUG

placebo

Administered subcutaneously ( s.c., under the skin) once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, age at least 18 years at the time of signing informed consent.
* Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
* HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
* BMI: 25.0 - 40.0 kg/m\^2 (both inclusive)

* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
* History of pancreatitis (acute or chronic)
* Screening calcitonin above or equal to 50 ng/L
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
* Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology)
* Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
* Currently planned coronary, carotid or peripheral artery revascularisation
* Patients presently classified as being in New York Heart Association (NYHA) Class III or IV

Exclusion Criteria

* Simultaneous participation in any other clinical trial of an investigational medicinal product
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Coronado, California, United States

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Lancaster, California, United States

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Riverside, California, United States

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Tustin, California, United States

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Van Nuys, California, United States

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Vista, California, United States

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Walnut Creek, California, United States

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Hartford, Connecticut, United States

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Boca Raton, Florida, United States

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Gainesville, Florida, United States

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Gainesville, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Ponte Vedra, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Evanston, Illinois, United States

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Evansville, Indiana, United States

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Newton, Kansas, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Marrero, Louisiana, United States

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Slidell, Louisiana, United States

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Slidell, Louisiana, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Buckley, Michigan, United States

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Belzoni, Mississippi, United States

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Bridgeton, Missouri, United States

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Kalispell, Montana, United States

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Elkhorn, Nebraska, United States

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Las Vegas, Nevada, United States

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Lawrenceville, New Jersey, United States

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Hopewell Junction, New York, United States

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Statesville, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Delaware, Ohio, United States

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Dublin, Ohio, United States

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Kettering, Ohio, United States

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Mason, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Corvallis, Oregon, United States

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Downingtown, Pennsylvania, United States

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Media, Pennsylvania, United States

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Smithfield, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Charleston, South Carolina, United States

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Hodges, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Old Point Station, South Carolina, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Missouri City, Texas, United States

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New Braunfels, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Waco, Texas, United States

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Bountiful, Utah, United States

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Clinton, Utah, United States

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Riverton, Utah, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Winchester, Virginia, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Graz, , Austria

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Saint Stefan, , Austria

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Vienna, , Austria

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Coquitlam, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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Sarnia, Ontario, Canada

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Strathroy, Ontario, Canada

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Laval, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Benešov, , Czechia

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Brno, , Czechia

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Liberec, , Czechia

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Náchod, , Czechia

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Pilsen, , Czechia

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Police nad Metují, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Trutnov, , Czechia

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Eisenach, , Germany

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Friedrichsthal, , Germany

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Hamburg, , Germany

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Münster, , Germany

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Pohlheim, , Germany

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Rehlingen-Siersburg, , Germany

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Saint Ingbert-Oberwürzbach, , Germany

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Stuttgart, , Germany

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Sulzbach-Rosenberg, , Germany

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George Town, , Malaysia

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Klang, Selangor, , Malaysia

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Kota Bharu, , Malaysia

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Seremban, , Malaysia

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Seri Manjung, , Malaysia

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Dzerzhinskiy, , Russia

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Kazan', , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Syktyvkar, , Russia

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Voronezh, , Russia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Niš, , Serbia

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Novi Sad, , Serbia

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Zaječar, , Serbia

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Midrand, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Durban, KwaZulu-Natal, South Africa

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Middleburg, Mpumalanga, South Africa

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Basingstoke, , United Kingdom

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Belfast, , United Kingdom

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Bexhill-on-Sea, , United Kingdom

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Blackburn, , United Kingdom

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Bristol, , United Kingdom

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Chesterfield, Derbyshire, , United Kingdom

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Devon, , United Kingdom

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Harrogate, North Yorkshire, , United Kingdom

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Hinckley, , United Kingdom

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Oxford, , United Kingdom

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Plymouth, , United Kingdom

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Sidcup, , United Kingdom

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Truro, , United Kingdom

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Countries

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United States Austria Canada Czechia Germany Malaysia Russia Serbia South Africa United Kingdom

References

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Lingvay I, Desouza CV, Lalic KS, Rose L, Hansen T, Zacho J, Pieber TR. A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or Without Metformin. Diabetes Care. 2018 Sep;41(9):1926-1937. doi: 10.2337/dc17-2381. Epub 2018 Jul 19.

Reference Type RESULT
PMID: 30026333 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2014-003196-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1159-4923

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4191

Identifier Type: -

Identifier Source: org_study_id

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