NNC0519-0130 for Type 2 Diabetes

Recruiting at 78 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

288 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.

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.

What makes the drug NNC0519-0130 unique for treating Type 2 Diabetes?

The available research does not provide specific information about how NNC0519-0130 differs from other treatments for Type 2 Diabetes. ^{1 2 3 4 5}

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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

I am between 18 and 75 years old.

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.

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Predictive factors associated with primary failure to exenatide and non goal attainment in patients with type 2 diabetes. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Diabetes teaching--outcome analysis. [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

NIDDM--the devastating disease. [2019]

4. New Zealand 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. [2008]

5. England pubmed.ncbi.nlm.nih.gov

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