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Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

NCT ID: NCT01930188

Last Updated: 2019-06-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-02

Study Completion Date

2015-10-12

Brief Summary

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This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) 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 0.5 mg + sitagliptin placebo

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

placebo

Intervention Type DRUG

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

Semaglutide 1.0 mg + sitagliptin placebo

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

placebo

Intervention Type DRUG

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

Sitagliptin 100 mg + semaglutide placebo 1.0 mg

Group Type ACTIVE_COMPARATOR

sitagliptin

Intervention Type DRUG

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

placebo

Intervention Type DRUG

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

Sitagliptin 100 mg + semaglutide placebo 0.5 mg

Group Type ACTIVE_COMPARATOR

sitagliptin

Intervention Type DRUG

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

placebo

Intervention Type DRUG

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

Interventions

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semaglutide

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

Intervention Type DRUG

sitagliptin

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

Intervention Type DRUG

placebo

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

Intervention Type DRUG

placebo

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.

Exclusion Criteria

5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV
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

Buenos Aires, , Argentina

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Novo Nordisk Investigational Site

CABA, , Argentina

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CABA, , Argentina

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Mar del Plata, , Argentina

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Burgas, , Bulgaria

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Haskovo, , Bulgaria

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Petrich, , Bulgaria

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Rousse, , Bulgaria

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Sliven, , Bulgaria

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Smolyan, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Vratsa, , Bulgaria

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Chrudim, , Czechia

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Ostrava, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Praha 4- Chodov, , Czechia

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Shatin, New Territories, , Hong Kong

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Szeged, , Hungary

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Szombathely, , Hungary

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Hyderabad, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Bangalore, Karnataka, 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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Trivandrum, Kerala, India

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Indore, Madhya Pradesh, 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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Pune, Maharashtra, India

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Bhubaneswar, Odisha, India

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Ludhiana, Punjab, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Kolkata, West Bengal, India

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Kolkata, West Bengal, India

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New Delhi, , India

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Asahikawa-shi, Hokkaido, , Japan

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Ibaraki, , Japan

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Kashiwara-shi, Osaka, , Japan

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Kitakyushu-shi, Fukuoka, , Japan

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Mitaka-shi, Tokyo, , Japan

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Mito-shi, Ibaraki, , Japan

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Miyazaki, , Japan

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Okayama-shi, Okayama, , Japan

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Osaka, , Japan

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Osaka-shi, Osaka, , Japan

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Osaka-shi, Osaka, , Japan

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Sapporo-shi, Hokkaido, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Pachuca, Hidalgo, Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Aguascalientes, , Mexico

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Aguascalientes, , Mexico

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Ålesund, , Norway

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Hamar, , Norway

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Kløfta, , Norway

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Kongsvinger, , Norway

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Stavanger, , Norway

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Almada, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Matosinhos Municipality, , 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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Baia Mare, Maramureş, Romania

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Ploieşti, Prahova, Romania

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Brasov, , Romania

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Bucharest, , Romania

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Barnaul, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Tomsk, , Russia

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Tyumen, , Russia

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Ufa, , Russia

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Volgograd, , Russia

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Voronezh, , Russia

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Yaroslavl, , Russia

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East London, Eastern Cape, South Africa

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Krugersdorp, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Pretoria, 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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A Coruña, , Spain

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Almería, , Spain

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Centelles (Barcelona), , Spain

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La Roca Del Vallés, , Spain

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Lleida, , Spain

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Palma de Mallorca, , Spain

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Seville, , Spain

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Kristianstad, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Bangkok, , Thailand

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Bangkok, , Thailand

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Bangkoknoi, Bangkok, , Thailand

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Nakhon Ratchasima, , Thailand

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Ankara, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Çorum, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Konya, , Turkey (Türkiye)

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Rize, , Turkey (Türkiye)

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Trabzon, , Turkey (Türkiye)

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Cherkasy, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhia, , Ukraine

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Countries

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Argentina Bulgaria Czechia Hong Kong Hungary India Japan Mexico Norway Portugal Romania Russia South Africa Spain Sweden Thailand Turkey (Türkiye) Ukraine

References

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Fonseca VA, Capehorn MS, Garg SK, Jodar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. J Clin Endocrinol Metab. 2019 Sep 1;104(9):4078-4086. doi: 10.1210/jc.2018-02685.

Reference Type BACKGROUND
PMID: 30938762 (View on PubMed)

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)

Ahrén B, Comas LM, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). Oral Presentation 12 Jun 2016 at American Diabetes Association - 76th Annual Scientific Sessions.

Reference Type RESULT

Ahrén B, Masmiquel L, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). ePoster #767 presented 12 Sep 2016 at European Association for the Study of Diabetes - 52nd Annual Meeting.

Reference Type RESULT

Ahren B, Masmiquel L, Kumar H, Sargin M, Karsbol JD, Jacobsen SH, Chow F. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol. 2017 May;5(5):341-354. doi: 10.1016/S2213-8587(17)30092-X. Epub 2017 Apr 3.

Reference Type RESULT
PMID: 28385659 (View on PubMed)

Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.

Reference Type RESULT
PMID: 29748996 (View on PubMed)

Ahren B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.

Reference Type RESULT
PMID: 29766634 (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)

DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.

Reference Type RESULT
PMID: 29862621 (View on PubMed)

Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.

Reference Type RESULT
PMID: 29907893 (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)

Pulleyblank R, Larsen NB. Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study. Pharmacoecon Open. 2023 Jul;7(4):579-591. doi: 10.1007/s41669-023-00416-z. Epub 2023 May 13.

Reference Type DERIVED
PMID: 37178435 (View on PubMed)

Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

Reference Type DERIVED
PMID: 32998732 (View on PubMed)

Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577.

Reference Type DERIVED
PMID: 32827435 (View on PubMed)

Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

Reference Type DERIVED
PMID: 32193837 (View on PubMed)

Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

Reference Type DERIVED
PMID: 31903692 (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)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-004827-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1135-8730

Identifier Type: OTHER

Identifier Source: secondary_id

132366

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2014/05/004626

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9535-3626

Identifier Type: -

Identifier Source: org_study_id

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A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
NCT05144984 COMPLETED PHASE2
Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
NCT01189890 COMPLETED PHASE3
A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
NCT00701090 COMPLETED PHASE3
Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00518882 COMPLETED PHASE3
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
NCT00700817 COMPLETED PHASE3
A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes
NCT03987919 COMPLETED PHASE3
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Spain, as Part of Local Clinical Practice
NCT04067999 COMPLETED
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
NCT00337610 COMPLETED PHASE3
A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)
NCT01076075 COMPLETED PHASE3
Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
NCT01338870 COMPLETED PHASE2
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
NCT02016911 COMPLETED PHASE1
Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
NCT01296412 COMPLETED PHASE3
Antidiabetic Effects of Adding a DPP-4 Inhibitor to Pre-Existing Treatment With an Incretin Mimetic in Patients With T2D
NCT01937598 COMPLETED PHASE3
Effect of Add-on SGLT2i, TZD, or Combination Therapy in Type 2 Diabetes Patients on DPP4 Inhibitors
NCT07108985 NOT_YET_RECRUITING PHASE4
Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
NCT01652729 COMPLETED PHASE3
A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)
NCT03175120 COMPLETED PHASE3
A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes
NCT07087795 RECRUITING PHASE1
Semaglutide vs Sitagliptin
NCT05195944 UNKNOWN PHASE4