CagriSema for Diabetic Neuropathy

Recruiting at 46 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

Must be taking: Oral anti-diabetics, Basal insulin

Must not be taking: GLP-1 RA, Opioids

Disqualifiers: Pregnancy, Epilepsy, Fibromyalgia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

134 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that your diabetes and pain treatments are stable for at least 3 months before screening. Some medications, like glucagon-like peptide-1 receptor agonists, must be stopped 60 days before screening.

How does the drug CagriSema differ from other treatments for diabetic neuropathy?

CagriSema is unique because it combines two components that may offer a novel approach to treating diabetic neuropathy, although specific details about its mechanism or effectiveness for this condition are not provided in the available research. Current treatments focus primarily on controlling blood sugar levels, and there is no specific standard treatment for diabetic neuropathy. ^{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 who also suffer from painful diabetic peripheral neuropathy. Participants will be involved in the study for approximately 10 months.

Inclusion Criteria

I am either male or female.

Body mass index (BMI) ≥25.0 kilogram per square meter (kg/m^2) at screening

I was diagnosed with type 2 diabetes more than 6 months ago.

Exclusion Criteria

I haven't used opioids, cannabinoids, or benzodiazepines heavily in the last month.

I don't plan to change my medications that affect weight or blood sugar during the study.

I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CagriSema or placebo subcutaneously once weekly. CagriSema is administered in a dose escalation manner for 16 weeks followed by a maintenance dose for another 16 weeks.

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

• CagriSema

Trial Overview The study is testing the effects of a new medication called CagriSema against a placebo (a 'dummy' medicine with no active ingredients). Patients are randomly assigned to receive either CagriSema or the placebo.

Participant Groups

Group I: CagriSema Experimental Treatment 1 Intervention

Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema (Cagrilintide B + Semaglutide I) maintenance dose subcutaneously once weekly for 16 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.

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

Meticulous control of blood glucose is the only consistently beneficial strategy for treating diabetic neuropathy, as shown in the Diabetes Control and Complications Trial with 1,500 patients, which delayed the onset and slowed the progression of neuropathy.

While glycemic control is crucial, there are concerns about the methods used to measure improvement in neuropathy and the risks of severe hypoglycemia, which can worsen nerve damage; thus, additional strategies, like aldose reductase inhibitors, are needed to further protect nerves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diabetic neuropathy. Parry, GJ.[2019]

Nishamalaki (NA), a combination of Curcuma longa and Emblica officinalis, significantly improved symptoms of diabetic neuropathy in type 2 diabetic rats, showing better efficacy than standard treatments like Glibenclamide, Epalrestat, and Pioglitazone at higher doses.

NA not only helped in controlling blood sugar levels and improving lipid profiles but also effectively prevented the development of diabetic neuropathy, indicating its potential as a therapeutic option for managing diabetic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Effect of Nishamalaki on STZ and HFHF Diet Induced Diabetic Neuropathy in Wistar Rats. Dawane, JS., Pandit, VA., Bhosale, MS., et al.[2020]

Curcuma caesia has potential therapeutic benefits for diabetic neuropathy due to its antioxidant properties, which can reduce oxidative stress, a key factor in the condition's development.

Additionally, its anti-inflammatory and antibacterial effects may help prevent neuron inflammation and infection, suggesting that this plant could be a valuable treatment option for managing diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the utility of Curcuma caesia in the treatment of diabetic neuropathy. Grover, M., Shah, K., Khullar, G., et al.[2019]

Diabetic neuropathy is a major complication of both type 1 and type 2 diabetes, affecting the autonomic nerves and leading to diabetic autonomic neuropathy.

The mechanisms behind diabetic neuropathy are thought to involve metabolic, vascular, and immunological factors, with many patients showing autonomic function abnormalities even without clinical symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Autonomic neuropathy in diabetic patients. Part I. Pathogenesis and clinical problems]. Otto-Buczkowska, E., Chobot, PJ.[2006]

In a study of 60 patients with symmetric diabetic polyneuropathy, those treated with cerebrolysin showed significant improvement in polyneuropathic symptoms compared to those receiving milgamma.

The effectiveness of cerebrolysin was assessed using the Diabetic Polyneuropathy Scale and the Neuropathy Disability Score, indicating its potential as a beneficial treatment option for managing diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of cerebrolysin therapy on the dynamics of diabetic polyneuropathy symptoms]. Bogdanov, EI., Sakovets, TG., Gil'mullin, IF.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Management of diabetic neuropathy. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Evaluation of Effect of Nishamalaki on STZ and HFHF Diet Induced Diabetic Neuropathy in Wistar Rats. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Investigation of the utility of Curcuma caesia in the treatment of diabetic neuropathy. [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

[Autonomic neuropathy in diabetic patients. Part I. Pathogenesis and clinical problems]. [2006]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Influence of cerebrolysin therapy on the dynamics of diabetic polyneuropathy symptoms]. [2016]