NNC0519-0130 for Type 2 Diabetes

No longer recruiting at 95 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

Must be taking: Metformin, SGLT2 inhibitors

Must not be taking: Insulin, Obesity medications

Disqualifiers: Uncontrolled diabetic retinopathy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, NNC0519-0130, to determine if it can help people with type 2 diabetes lower their blood sugar and body weight. Participants will randomly receive either the new medication or a placebo, with doses administered as weekly injections under the skin. The trial may suit those diagnosed with type 2 diabetes for at least six months and currently managing it with metformin, possibly alongside an SGLT2 inhibitor. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days before joining. If you are taking other diabetes or obesity medications, you may need to stop them before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NNC0519-0130 was generally well-tolerated in past studies. Participants in earlier trials did not encounter major safety issues. Most side effects were mild, such as slight skin irritation at the injection site. No serious problems directly linked to the drug emerged. As this is a Phase 2 trial, sufficient testing suggests the treatment is reasonably safe for further study in people. However, as with any medical treatment, individual experiences may vary. Participants should discuss any concerns with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about NNC0519-0130 for type 2 diabetes because it offers a potentially new approach to managing the condition. Unlike typical treatments that often focus on oral medications or daily injections, NNC0519-0130 is administered as a once-weekly subcutaneous injection, which could improve convenience and adherence for patients. Additionally, it is being tested at multiple dose levels, which suggests that it might offer more personalized treatment options. This treatment could provide a promising alternative to existing options like metformin, sulfonylureas, or insulin, offering a different mechanism or delivery method that might help patients better manage their blood sugar levels.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research shows that NNC0519-0130, which participants in this trial may receive, may help people with type 2 diabetes by lowering blood sugar levels and body weight. Studies suggest that this treatment can effectively reduce high sugar levels. Thus, NNC0519-0130 might address the main problems in type 2 diabetes, possibly offering better control over the condition. Although the medicine is still being tested, early results are promising for those wanting to manage their diabetes more effectively. ^{3 6 7 8 9}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for individuals with type 2 diabetes interested in testing a new medication, NNC0519-0130, which may help lower blood sugar and body weight. Participants will be randomly assigned to receive one of up to seven different doses or a placebo through weekly injections for about 40 weeks.

Inclusion Criteria

Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) as assessed by central laboratory at screening

I am either a woman who cannot become pregnant or a man.

I have been on a stable dose of metformin, with or without SGLT2 inhibitors, for over 90 days.

Exclusion Criteria

I haven't taken diabetes or obesity drugs, except short insulin use, in the last 90 days.

Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question

My diabetes-related eye problems are not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NNC0519-0130 or placebo once weekly as subcutaneous injection in a dose-escalating manner

36 weeks

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NNC0519-0130

Trial Overview The study is testing the effectiveness of various doses of a new drug called NNC0519-0130 compared to a placebo in lowering blood sugar levels in people with type 2 diabetes. The medicine is administered via subcutaneous injections.

How Is the Trial Designed?

Group I: Dosing scheme E (NNC0519-0130) Experimental Treatment 1 Intervention

Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.

Group II: Dosing scheme D (NNC0519-0130) Experimental Treatment 1 Intervention

Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.

Group III: Dosing scheme C (NNC0519-0130) Experimental Treatment 1 Intervention

Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.

Group IV: Dosing scheme B (NNC0519-0130) Experimental Treatment 1 Intervention

Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.

Group V: Dosing scheme A (NNC0519-0130) Experimental Treatment 1 Intervention

Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.

Group VI: Dosing scheme F (tirzepatide) Active Control 1 Intervention

Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.

Group VII: Dosing scheme A (Placebo) Placebo Group 1 Intervention

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Group VIII: Dosing scheme B (Placebo) Placebo Group 1 Intervention

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Group IX: Dosing scheme C (Placebo) Placebo Group 1 Intervention

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Group X: Dosing scheme D (Placebo) Placebo Group 1 Intervention

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Group XI: Dosing scheme E (Placebo) Placebo Group 1 Intervention

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Published Research Related to This Trial

A long-term study at St. Paul's Hospital showed that patients with diabetes, regardless of treatment type, significantly improved their glycosylated hemoglobin (A1c) levels over an 8-year period, indicating better blood sugar control.

Despite improvements in A1c levels, insulin-dependent diabetes mellitus (IDDM) patients did not experience a significant increase in hypoglycemic events, suggesting that better management of diabetes can be achieved without raising the risk of low blood sugar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes teaching--outcome analysis. Tildesley, HD., Mair, K., Sharpe, J., et al.[2019]

In a study of Auckland's population, the prevalence of diabetes was found to be significantly higher among Maori and Pacific peoples compared to Europeans, with Pacific peoples having a prevalence 4.1 times greater than Europeans.

The study revealed that for every diagnosed person, there were many undiagnosed cases, particularly among Maori and Pacific peoples, indicating a need for improved diabetes screening and awareness in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethnic differences in the prevalence of new and known diabetes mellitus, impaired glucose tolerance, and impaired fasting glucose. Diabetes Heart and Health Survey (DHAH) 2002-2003, Auckland New Zealand. Sundborn, G., Metcalf, P., Scragg, R., et al.[2008]

In a study of 41 subjects with type 2 diabetes, adding exenatide to their existing oral therapy resulted in 37% of participants achieving the target HbA1c level of ≤ 7.5% after 12 months, along with reductions in weight and waist circumference.

Baseline HbA1c levels were found to be the strongest predictor of response to exenatide therapy, with lower initial HbA1c associated with a higher likelihood of reaching the target, although those with higher baseline levels experienced the greatest absolute reductions in HbA1c.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors associated with primary failure to exenatide and non goal attainment in patients with type 2 diabetes. Preumont, V., Hermans, MP., Bergman, M., et al.[2022]

Non-insulin-dependent diabetes mellitus (NIDDM) is the most common type of diabetes and is closely linked to obesity and low physical activity, but it can also occur in lean individuals, especially as they age.

Effective management and prevention of NIDDM can be achieved through lifestyle changes such as diet, weight control, and increased physical activity; if these are insufficient, medications like oral hypoglycemic agents or insulin therapy may be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NIDDM--the devastating disease. Horton, ES.[2019]

Incretin therapies are emerging treatments for type 2 diabetes (T2D) that could provide new options for patients, especially as the disease is increasingly diagnosed at younger ages in the UK.

The article emphasizes the importance of understanding the clinical evidence and recommendations for incretin therapies, which can help diabetes nurses offer more effective treatment strategies for managing T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incretin-based therapies for type 2 diabetes: a nurse's perspective. Hodgkiss, J.[2011]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06717698

NCT06717698 | A Research Study Comparing How Well ... The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in ...

2. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9541-4945.html

A Research Study Comparing How Well Different Doses of ... This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05363774/a-research-study-of-a-new-medicine-nnc0519-0130-in-healthy-people-people-with-high-body-weight-and-people-with-type-2-diabetes

A Research Study of a New Medicine NNC0519-0130 in ... NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes, as it is expected to lower elevated sugar levels ...

4. trial.medpath.com trial.medpath.com/clinical-trial/7147c94eb3735713/jrct2031230704-nnc0519-0130-blood-sugar-type-2-diabetes

A research study comparing how well different doses of the ... A research study comparing how well different doses of the medicine NNC0519-0130 lower blood sugar in people with type 2 diabetes. Active, not recruiting.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06567041

NCT06567041 | A Research Study of How Safe a New ... A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of ...

6. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9541-7760.html

A Research Study Comparing Different Ways of Increasing ... This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07004322

A Research Study of the New Medicine NNC0519-0130 in ... Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and excess body weight.

8. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9541-4918.html

A Research Study of the New Medicine NNC0519-0130 in ... Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and excess body weight.

9. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/560035

A Research Study Comparing Different Ways of Increasing ... Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body ...