NCT02254291|CompletedPhase 3Results

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

SUSTAIN™

Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9535-4092U1111-1140-5334JapicCTI-142663

Study Type

interventional

Target

308

Locations

1 country

Sites

Timeline

RegisteredOct 2014

StartedOct 2014

CompletionNov 2015

Brief Summary

This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

308

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Oct 2014

Geographic Reach

1 country

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

September 29, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed

1 day until next milestone

Study Start

First participant enrolled

October 2, 2014

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2015

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

September 13, 2018

Completed

Last Updated

September 13, 2018

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

September 29, 2014

Results QC Date

December 21, 2017

Last Update Submit

December 21, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Number of Treatment Emergent Adverse Events (TEAEs)
An adverse events (AEs) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
Weeks 0-30

Secondary Outcomes (2)

Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Weeks 0-30
Change in Glycosylated Haemoglobin A1c (HbA1c)
Week 0 and week 30

Study Arms (3)

Semaglutide 0.5 mg

EXPERIMENTAL

Drug: semaglutide

Semaglutide 1.0 mg

EXPERIMENTAL

Drug: semaglutide

Sitagliptin 100 mg

ACTIVE COMPARATOR

Drug: sitagliptin

Interventions

semaglutideDRUG

Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).

Semaglutide 0.5 mg

sitagliptinDRUG

Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.

Sitagliptin 100 mg

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, age 20 years or older at the time of signing informed consent
Glycated hemoglobin (HbA1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug (OAD) monotherapy and between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy at screening
Japanese subjects diagnosed with type 2 diabetes who are: a) on stable OAD monotherapy at a half-maximum dose or below according to the approved Japanese labelling in addition to diet and exercise therapy for at least 30 days prior to screening (week -8) (For metformin only: the maximum dose of 750 mg/day is allowed except for METGLUCO®. For METGLUCO®, the allowable half-max dose of 1125 mg/day must be applied.). 'Stable' is defined as unchanged medication and unchanged dose, or b) on stable diet and exercise therapy for at least 30 days prior to screening (week -2)

You may not qualify if:

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g. abstinence, diaphragm, condom \[by the partner\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5-week follow-up period
Treatment with once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days prior to screening
Treatment with any glucose lowering agent(s) (except for pre-trial OAD for subject treated with OAD monotherapy) in a period of 60 days prior to screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness
Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
History of chronic or idiopathic acute pancreatitis
Screening calcitonin value of 50 ng/L (pg/mL) or greater
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
Impaired renal function defined as estimated glomerular filtration rate (eGFR) less than 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

Contact the study team to confirm eligibility.