60 Participants Needed

Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

(RT1D Trial)

Recruiting at 3 trial locations
JT
EA
JP
EA
LZ
Overseen ByLeila Zelnick, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Washington
Must be taking: Blood pressure drugs, Lipid-lowering drugs
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stay on stable doses of blood pressure and lipid-lowering medications for at least 4 weeks before starting and throughout the trial. Other medications, especially those not approved for type 1 diabetes, may need to be stopped.

What data supports the effectiveness of the drug semaglutide for diabetic kidney disease in type 1 diabetes?

Semaglutide, a drug used for type 2 diabetes, has shown benefits like better blood sugar control, weight loss, and kidney protection in patients with kidney disease. These effects suggest it might help people with type 1 diabetes and kidney issues too.12345

Is semaglutide safe for humans?

Semaglutide, used under names like Ozempic, Wegovy, and Rybelsus, has been shown to be generally safe in humans, with studies indicating it is well-tolerated and has a good safety profile, especially in people with type 2 diabetes and chronic kidney disease.12346

How is the drug semaglutide unique for treating diabetic kidney disease in type 1 diabetes?

Semaglutide is unique because it is a glucagon-like peptide-1 receptor agonist (GLP-1RA) that not only improves blood sugar control but also offers additional benefits like reducing blood pressure, inflammation, and weight, which are important for kidney health. It is administered once weekly as a subcutaneous injection, making it convenient for patients, and it has shown potential in preserving kidney function, which is crucial for those with diabetic kidney disease.13478

What is the purpose of this trial?

The primary objective of this study is to determine the effects of semaglutide on kidney oxygenation and function in type 1 diabetes. The secondary objective is to determine the glycemic effects and safety of semaglutide in type 1 diabetes.

Research Team

Pharmacology and Toxicology

David Cherney

Principal Investigator

University of Toronto

Bio

Irl Hirsch, MD

Principal Investigator

University of Washington

Id

Ian de Boer, MD

Principal Investigator

University of Washington

JK

Jessica Kendrick, MD

Principal Investigator

University of Colorado Anschutz Medical Campus and Children's Hospital Colorado

KT

Katherine Tuttle, MD

Principal Investigator

Providence Healthcare

Eligibility Criteria

This trial is for adults over 18 with type 1 diabetes who have had the condition for at least five years and are showing signs of kidney disease. They must have stable blood pressure and cholesterol medication use, and women able to have children need to use birth control.

Inclusion Criteria

Adequate contraceptive method for females of child-bearing potential
I have been on stable doses of my cholesterol medication for at least 4 weeks.
Persistent urine albumin-to-creatinine ratio (UACR) ≥ 30 mg/g, on the most recent two measurements within the prior 3 years
See 4 more

Exclusion Criteria

I have had pancreatitis before.
I have a type of diabetes that is not caused by another condition.
My blood pressure is controlled and not above 160/100 mm Hg.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Real-time continuous glucose monitoring is used to control glycemia prior to randomization

2-4 weeks

Treatment

Participants receive semaglutide or placebo with titration to maximum target dose over 12 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Semaglutide
Trial Overview The study tests if Semaglutide can improve kidney oxygenation and function in people with type 1 diabetes. It also looks at how it affects blood sugar levels and its overall safety compared to a placebo (a treatment with no active drug).
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Semaglutide group from 0.25mg to 1.0mg
Group II: PlaceboPlacebo Group1 Intervention
Placebo group

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇺🇸
Approved in United States as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇨🇦
Approved in Canada as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇯🇵
Approved in Japan as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇺🇸
Approved in United States as Wegovy for:
  • Obesity
🇺🇸
Approved in United States as Rybelsus for:
  • Type 2 diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials
237
Recruited
142,000+

Providence Healthcare

Collaborator

Trials
19
Recruited
3,500+

University of Toronto

Collaborator

Trials
739
Recruited
1,125,000+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

Findings from Research

Subcutaneous semaglutide (Ozempic®), a GLP-1 receptor agonist, has shown significant efficacy in improving glycemic control and reducing HbA1c, albuminuria, and blood pressure in patients with advanced diabetic kidney disease (DKD) during a 6-month follow-up study involving patients on maintenance hemodialysis.
The treatment not only aids in weight loss and appetite suppression but also helps preserve residual kidney function, potentially improving patient outcomes and facilitating their inclusion on kidney transplant waiting lists.
Efficacy and Safety of Semaglutide, a Glucagon-Like Peptide-1 Receptor Agonist in Real-Life: A Case Series of Patients in Maintenance Incremental Hemodialysis.De la Flor, JC., Lorenzo, JD., Marschall, A., et al.[2022]
Oral semaglutide (Rybelsus®), a GLP-1 receptor agonist, not only helps lower blood sugar levels in people with type 2 diabetes but also promotes significant weight loss and has a lower risk of causing hypoglycemia.
Clinical studies indicate that GLP-1 receptor agonists are safe for individuals with type 2 diabetes and chronic kidney disease, and they may offer additional benefits such as protecting kidney function and reducing the risk of major cardiovascular events.
A Peptide in a Pill - Oral Semaglutide in the Management of Type 2 Diabetes.Selvarajan, R., Subramanian, R.[2023]
In a post-hoc analysis of 8416 patients with type 2 diabetes from multiple trials, semaglutide initially caused a decline in estimated glomerular filtration rate (eGFR), but this decline plateaued over time, indicating no long-term adverse effects on kidney function compared to placebo.
Semaglutide significantly reduced urinary albumin-to-creatinine ratio (UACR), suggesting improved kidney health, and there was no increase in kidney-related adverse events compared to other treatments, highlighting its safety and efficacy in managing kidney function in diabetic patients.
Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials.Mann, JFE., Hansen, T., Idorn, T., et al.[2020]

References

Efficacy and Safety of Semaglutide, a Glucagon-Like Peptide-1 Receptor Agonist in Real-Life: A Case Series of Patients in Maintenance Incremental Hemodialysis. [2022]
A Peptide in a Pill - Oral Semaglutide in the Management of Type 2 Diabetes. [2023]
Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials. [2020]
Glucagon-like peptide 1(GLP-1) receptor agonists in the management of the patient with type 2diabetes mellitus and chronic kidney disease: an approach for the nephrologist. [2023]
Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment. [2018]
[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]
Nephroprotective Effects of Semaglutide as Mono- and Combination Treatment with Lisinopril in a Mouse Model of Hypertension-Accelerated Diabetic Kidney Disease. [2022]
Influence of chronic kidney disease and its severity on the efficacy of semaglutide in type 2 diabetes patients: a multicenter real-world study. [2023]
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