A research study to look into how semaglutide, together with a lower dose of insulin glargine, compares to a higher dose of insulin glargine alone in people with type 2 diabetes (SUSTAIN OPTIMIZE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

31 Aug 2022 → 9 Apr 2025

Decision date (initial)

2024-08-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-510612-75-00

EudraCT number

2021-004392-13

WHO UTN

U1111-1267-0312

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To confirm that efficacy as measured by change from baseline to week 40 in HbA1c (%-point) of OW semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine U100 is not unacceptably worse (i.e., non-inferior) to that of titrated insulin glargine U100 on change from baseline to week 40 in HbA1c (%-point) in participants with T2D and overweight treated with a once daily basal insulin up to 40 U/day. Non-inferiority is assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.

Secondary objectives 1

1. To confirm superiority of OW semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine U100 versus titrated insulin glargine U100 on change from baseline to week 40 in body weight (kg) in participants with T2D, overweight and treated with a once daily basal insulin up to 40 U/day.

Conditions and MedDRA coding

Participants with T2D and overweight

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Diagnosed with T2D mellitus ≥180 days before screening.
2. HbA1c of 7-10% (53−86 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
3. Body mass index (BMI) ≥25 kg/m2 on the day of screening.
4. Stable daily dose(s) ≥90 days before screening of any of the following anti-diabetic drugs or combination regimens: -Any metformin formulations ≥1500 mg or maximum tolerated or effective dose. -Any metformin combination formulation ≥1500 mg or maximum tolerated or effective dose. The treatment can be with or without SGLT-2 inhibitors.
5. Treated with a once daily basal insulin (e.g. insulin glargine U100 or U300, NPH insulin, insulin detemir, insulin degludec) ≤40 U/day for ≥90 days before screening. Short-term bolus insulin treatment for a maximum of 14 days before screening is allowed.

Exclusion criteria 6

1. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
2. Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide <0.26 nmol/L or 260 pmol/L (0.78 ng/mL) or antibodies to glutamic acid decarboxylase (anti-GAD) >5 units/mL, as measured by the central laboratory at screening.
3. Presence or historya of pancreatitis (acute or chronic).
4. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of <30 mL/min/1.73 m2 at screening as defined by KDIGO 2012 classification.
5. Any episodes of diabetic ketoacidosis within 90 days before screening.
6. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in HbA1c from baseline (week 0) to end of treatment (week 40)

Secondary endpoints 4

1. Change in body weight from baseline (week 0) to end of treatment (week 40)
2. Relative change in daily insulin dose from baseline (week 0) to end of treatment (week 40)
3. Change in HbA1c From baseline (week 0) to end of treatment (week 40)
4. Score of Diabetes Treatment Satisfaction Questionnaire – change version (DTSQc) At end of treatment (week 40)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 7

Locations

7 EU/EEA countries · 60 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 55 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications