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Efficacy and Safety of Semagl...

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)

Last Updated: 2021-03-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

868 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2019-04-15

Brief Summary

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This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on their stable pre-trial metformin.

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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 OW + sitagliptin placebo OD

Group Type EXPERIMENTAL

Semaglutide 0.5 mg

Intervention Type DRUG

Up to 0.5 mg semaglutide injected subcutaneously (s.c., under the skin) once-weekly (OW) for 30 weeks

Sitagliptin placebo

Intervention Type DRUG

Sitagliptin placebo tablets taken once-daily for 30 weeks

Semaglutide 1 mg OW + sitagliptin placebo OD

Group Type EXPERIMENTAL

Semaglutide 1.0 mg

Intervention Type DRUG

Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 30 weeks

Sitagliptin placebo

Intervention Type DRUG

Sitagliptin placebo tablets taken once-daily for 30 weeks

Sitagliptin OD + semaglutide placebo 0.5 mg OW

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

100 mg sitagliptin tablets taken once-daily for 30 weeks

Semaglutide placebo 0.5 mg

Intervention Type DRUG

Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks

Sitagliptin OD + semaglutide placebo 1 mg OW

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

100 mg sitagliptin tablets taken once-daily for 30 weeks

Semaglutide placebo 1.0 mg

Intervention Type DRUG

Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks

Interventions

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Semaglutide 0.5 mg

Up to 0.5 mg semaglutide injected subcutaneously (s.c., under the skin) once-weekly (OW) for 30 weeks

Intervention Type DRUG

Semaglutide 1.0 mg

Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 30 weeks

Intervention Type DRUG

Sitagliptin placebo

Sitagliptin placebo tablets taken once-daily for 30 weeks

Intervention Type DRUG

Sitagliptin

100 mg sitagliptin tablets taken once-daily for 30 weeks

Intervention Type DRUG

Semaglutide placebo 0.5 mg

Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks

Intervention Type DRUG

Semaglutide placebo 1.0 mg

Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age equal to or above 18 years at the time of signing informed consent - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 60 days prior to screening with metformin equal to or above 1500 mg (or maximum tolerated dose equal to or above 1000 mg). Stable is defined as unchanged medication and unchanged daily dose - HbA1c 7.0 - 10.

Exclusion Criteria

5 % (53-91 mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measure as required by local regulation or practice) - Any disorder 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 60 days before screening. An exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 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 m\^2 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

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Aparecida de Goiânia, Goiás, Brazil

Site Status

Novo Nordisk Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Novo Nordisk Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Novo Nordisk Investigational Site

Hefei, Anhui, China

Site Status