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Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.

NCT ID: NCT02648204

Last Updated: 2019-10-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-06

Study Completion Date

2017-05-19

Brief Summary

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This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin 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

NONE

Study Groups

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Semaglutide 0.5 mg/Week

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

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

Semaglutide 1.0 mg/Week

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

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

Dulaglutide 0.75 mg/Week

Group Type ACTIVE_COMPARATOR

Dulaglutide

Intervention Type DRUG

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

Dulaglutide 1.5 mg/Week

Group Type ACTIVE_COMPARATOR

Dulaglutide

Intervention Type DRUG

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

Interventions

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semaglutide

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

Intervention Type DRUG

Dulaglutide

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.

Exclusion Criteria

5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
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

Tuscumbia, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Anaheim, California, United States

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Buena Park, California, United States

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Carlsbad, California, United States

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Concord, California, United States

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Huntington Park, California, United States

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Lincoln, California, United States

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Los Angeles, California, United States

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Montclair, California, United States

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Poway, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Tustin, California, United States

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Van Nuys, California, United States

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Denver, Colorado, United States

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Norwalk, Connecticut, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Edgewater, Florida, United States

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Fort Lauderdale, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Adairsville, Georgia, United States

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Atlanta, Georgia, United States

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Bainbridge, Georgia, United States

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Conyers, Georgia, United States

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Marietta, Georgia, United States

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Marietta, Georgia, United States

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Suwanee, Georgia, United States

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Meridian, Idaho, United States

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Addison, Illinois, United States

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Chicago, Illinois, United States

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Gillespie, Illinois, United States

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Gurnee, Illinois, United States

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Indianapolis, Indiana, United States

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Muncie, Indiana, United States

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Newton, Kansas, United States

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Park City, Kansas, United States

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Covington, Kentucky, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Hyattsville, Maryland, United States

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Oxon Hill, Maryland, United States

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Methuen, Massachusetts, United States

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Rochester, Michigan, United States

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Port Gibson, Mississippi, United States

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Missoula, Montana, United States

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Trenton, New Jersey, United States

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Tulsa, Oklahoma, United States

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Corvallis, Oregon, United States

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Fleetwood, Pennsylvania, United States

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Harleysville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Greer, South Carolina, United States

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Moncks Corner, South Carolina, United States

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Spartanburg, South Carolina, United States

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Rapid City, South Dakota, United States

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Humboldt, Tennessee, United States

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Arlington, Texas, United States

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Corpus Christi, Texas, United States

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Spokane, Washington, United States

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Walla Walla, Washington, United States

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Wenatchee, Washington, United States

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Blagoevgrad, , Bulgaria

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Burgas, , Bulgaria

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Montana, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Karlovac, , Croatia

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Krapinske Toplice, , Croatia

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Zagreb, , Croatia

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Jyväskylä, , Finland

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Kerava, , Finland

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Kuusamo, , Finland

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Raisio, , Finland

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Tampere, , Finland

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Turku, , Finland

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Dresden, , Germany

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Falkensee, , Germany

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Friedrichsthal, , Germany

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Hamburg, , Germany

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Münster, , Germany

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Rehlingen-Siersburg, , Germany

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Saint Ingbert-Oberwürzbach, , Germany

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Athens, , Greece

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Athens, , Greece

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Chalkida, Evia, , Greece

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Ioannina, , Greece

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Piraeus, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Shatin, New Territories, , Hong Kong

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Guntur, Andhra Pradesh, India

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Hyderabad, Andhra Pradesh, India

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Visakhapatnam, Andhra Pradesh, India

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Guwahati, Assam, India

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Ahmedabad, Gujarat, India

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Bangalore, Karnataka, India

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Kochi, Kerala, India

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Kozhikode, Kerala, India

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Indore, Madhya Pradesh, India

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Goa, Maharashtra, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Pune, Maharashtra, India

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Delhi, New Delhi, India

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New Dehli, New Delhi, India

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Bhubaneswar, Odisha, India

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Mohali, Punjab, India

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Chennai, Tamil Nadu, India

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Vellore, Tamil Nadu, India

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Kolkata, West Bengal, India

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Kolkata, West Bengal, India

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Hyderabad, , India

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Ludhiana, , India

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New Delhi, , India

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Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Galway, , Ireland

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Gorey, , Ireland

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Panevezys, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Almada, , Portugal

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Aveiro, , Portugal

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Lisbon, , Portugal

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Tomar, , Portugal

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Viana do Castelo, , Portugal

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Vila Nova de Gaia, , Portugal

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Ponce, , Puerto Rico

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Oradea, Bihor County, Romania

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Târgu Mureş, Mureș County, Romania

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Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Buzău, , Romania

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Galati, , Romania

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Levice, , Slovakia

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Piešťany, , Slovakia

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Poprad, , Slovakia

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Prievidza, , Slovakia

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Alicante, , Spain

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La Roca Del Vallés, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Palma de Mallorca, , Spain

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Palma de Mallorca, , Spain

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Segovia, , Spain

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Seville, , Spain

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Vic (Barcelona), , Spain

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Bradford-on-Avon, , United Kingdom

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Northwood, , United Kingdom

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Romford, , United Kingdom

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Soham, , United Kingdom

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Southampton, , United Kingdom

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Southampton, , United Kingdom

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Stevenage, , United Kingdom

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Watford, , United Kingdom

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Countries

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United States Bulgaria Croatia Finland Germany Greece Hong Kong India Ireland Latvia Lithuania Portugal Puerto Rico Romania Slovakia Spain United Kingdom

References

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Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.

Reference Type BACKGROUND
PMID: 30865526 (View on PubMed)

Johansen P, Hakan-Bloch J, Liu AR, Bech PG, Persson S, Leiter LA. Cost Effectiveness of Once-Weekly Semaglutide Versus Once-Weekly Dulaglutide in the Treatment of Type 2 Diabetes in Canada. Pharmacoecon Open. 2019 Dec;3(4):537-550. doi: 10.1007/s41669-019-0131-6.

Reference Type BACKGROUND
PMID: 30927241 (View on PubMed)

Malkin SJP, Russel-Szymczyk M, Psota M, Hlavinkova L, Hunt B. The Management of Type 2 Diabetes with Once-Weekly Semaglutide Versus Dulaglutide: A Long-Term Cost-Effectiveness Analysis in Slovakia. Adv Ther. 2019 Aug;36(8):2034-2051. doi: 10.1007/s12325-019-00965-y. Epub 2019 Jun 5.

Reference Type BACKGROUND
PMID: 31168765 (View on PubMed)

Pratley RE, Aroda VR, Lingvay I, Ludemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018 Apr;6(4):275-286. doi: 10.1016/S2213-8587(18)30024-X. Epub 2018 Feb 1.

Reference Type RESULT
PMID: 29397376 (View on PubMed)

Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.

Reference Type RESULT
PMID: 29246950 (View on PubMed)

Sharma R, Wilkinson L, Vrazic H, Popoff E, Lopes S, Kanters S, Druyts E. Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis. Curr Med Res Opin. 2018 Sep;34(9):1595-1603. doi: 10.1080/03007995.2018.1476332. Epub 2018 May 29.

Reference Type RESULT
PMID: 29764222 (View on PubMed)

Wilkinson L, Hunt B, Johansen P, Iyer NN, Dang-Tan T, Pollock RF. Cost of Achieving HbA1c Treatment Targets and Weight Loss Responses with Once-Weekly Semaglutide Versus Dulaglutide in the United States. Diabetes Ther. 2018 Jun;9(3):951-961. doi: 10.1007/s13300-018-0402-8. Epub 2018 Mar 19.

Reference Type RESULT
PMID: 29557057 (View on PubMed)

Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.

Reference Type RESULT
PMID: 30615985 (View on PubMed)

Viljoen A, Hoxer CS, Johansen P, Malkin S, Hunt B, Bain SC. Evaluation of the long-term cost-effectiveness of once-weekly semaglutide versus dulaglutide for treatment of type 2 diabetes mellitus in the UK. Diabetes Obes Metab. 2019 Mar;21(3):611-621. doi: 10.1111/dom.13564. Epub 2018 Nov 28.

Reference Type RESULT
PMID: 30362224 (View on PubMed)

Osumili B, Fan L, Paik JS, Pantalone KM, Ranta K, Sapin H, Tofe S. Tirzepatide 5, 10 and 15 mg versus injectable semaglutide 0.5 mg for the treatment of type 2 diabetes: An adjusted indirect treatment comparison. Diabetes Res Clin Pract. 2024 Jun;212:111717. doi: 10.1016/j.diabres.2024.111717. Epub 2024 May 21.

Reference Type DERIVED
PMID: 38777128 (View on PubMed)

Pratley RE, Aroda VR, Catarig AM, Lingvay I, Ludemann J, Yildirim E, Viljoen A. Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses. BMJ Open. 2020 Nov 16;10(11):e037883. doi: 10.1136/bmjopen-2020-037883.

Reference Type DERIVED
PMID: 33199417 (View on PubMed)

DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.

Reference Type DERIVED
PMID: 31769496 (View on PubMed)

Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.

Reference Type DERIVED
PMID: 31215727 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2014-005375-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1164-8495

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4216

Identifier Type: -

Identifier Source: org_study_id

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