NCT02207374|CompletedPhase 3Results

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

SUSTAIN™

Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9535-4091U1111-1140-3081JapicCTI-142640

Study Type

interventional

Target

601

Locations

1 country

Sites

Timeline

RegisteredAug 2014

StartedAug 2014

CompletionFeb 2016

Brief Summary

This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy. All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.

Trial Health

On Track

Trial Health Score

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

Enrollment

601

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Aug 2014

Typical duration for phase_3 diabetes

Geographic Reach

1 country

43 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

1.6 years study duration

First Submitted

Initial submission to the registry

August 1, 2014

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed

Same day until next milestone

Study Start

First participant enrolled

August 4, 2014

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2016

Completed

2.9 years until next milestone

Results Posted

Study results publicly available

January 7, 2019

Completed

Last Updated

January 7, 2019

Status Verified

June 1, 2018

Enrollment Period

1.6 years

First QC Date

August 1, 2014

Results QC Date

December 21, 2017

Last Update Submit

June 21, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Number of Treatment Emergent Adverse Events (TEAEs)
An adverse event (AEs) was defined as any unfavorable 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 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
Weeks 0-56

Secondary Outcomes (2)

Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Weeks 0-56
Change in Glycosylated Haemoglobin A1c (HbA1c)
Week 0, week 56

Study Arms (3)

Semaglutide 0.5 mg

EXPERIMENTAL

Drug: semaglutide

Semaglutide 1.0 mg

EXPERIMENTAL

Drug: semaglutide

One additional OAD + pre-trial treatment

ACTIVE COMPARATOR

The type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD should be chosen.

Drug: DPP-4 inhibitor

Interventions

semaglutideDRUG

Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.

Semaglutide 0.5 mgSemaglutide 1.0 mg

DPP-4 inhibitorDRUG

Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.

One additional OAD + pre-trial treatment

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female, age at least 20 years at the time of signing informed consent
HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)
Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and exercise therapy for at least 60 days before Visit 1 (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 \[not having sex\], diaphragm, condom \[by the partner\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period
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 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 (MEN2)
Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 30 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 (Visit 2 \[week 0\])
Heart failure, New York Heart Association (NYHA) class IV

Contact the study team to confirm eligibility.