Semaglutide for Diabetic Kidney Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Geisinger Medical Center, Danville, PADiabetic Kidney Disease+4 MoreSemaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether semaglutide, a diabetes medication, can help people with diabetes and kidney disease who are overweight or obese.

Eligible Conditions
  • Diabetic Kidney Disease
  • Obesity
  • Chronic Kidney Disease
  • Type 2 Diabetes Mellitus in Obesity
  • Severe Obesity

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
GLP-1 analogue - semaglutide
1
Semaglutide 3mg and 7mg [Rybelsus]
1
SLIMM

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Baseline to 9 months

Month 9
Kidney transplant eligibility
Month 9
Activation on the transplant list
Receipt of kidney transplant
Baseline to 9 months
Change in Low-Density Lipoprotein (LDL)
Albuminuria
Change in diastolic blood pressure
Change in estimated glomerular filtration (eGFR) rate among subset of participants without end-stage kidney disease
Change in systolic blood pressure
Change in triglycerides
Entire 9-month study period
All-cause hospitalizations
Cardiovascular disease (CVD) events
Proportion experiencing acute pancreatitis events
Proportion experiencing allergic reactions
Proportion experiencing death
Proportion experiencing doubling of creatinine or end-stage kidney disease
Proportion experiencing gallbladder disorders
Proportion experiencing gastrointestinal disorders
Proportion experiencing hepatic events
Hypoglycemia
Proportion experiencing injection-site reactions
Proportion experiencing neoplasms
Month 9
Change in BMI
Change in body fat percentage
Change in hemoglobin A1c (HgbA1c)
Change in waist circumference
Change in waist-to-hip ratio

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
GLP-1 analogue - semaglutide
2
Semaglutide 3mg and 7mg [Rybelsus]
2
SLIMM

Trial Design

2 Treatment Groups

Semaglutide
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

15 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide · Has Placebo Group · Phase 3

Semaglutide
Drug
ActiveComparator Group · 1 Intervention: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 9 months

Who is running the clinical trial?

Geisinger ClinicLead Sponsor
136 Previous Clinical Trials
1,359,119 Total Patients Enrolled
Alex R Chang, MD, MSPrincipal InvestigatorGeisinger Clinic
1 Previous Clinical Trials
31 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) of 25-45 kg/m2.

Who else is applying?

What state do they live in?
Maryland66.7%
Florida33.3%
How old are they?
65+100.0%
What site did they apply to?
Geisinger Medical Center100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
References

Frequently Asked Questions

Are there any Semaglutide-related fatalities on record?

"Semaglutide was given a score of 3 by our team at Power. This is due to this medication being in Phase 3 trials, which indicates that there is not just some evidence of efficacy, but multiple rounds of data supporting safety as well." - Anonymous Online Contributor

Unverified Answer

What medical conditions respond well to Semaglutide?

"Semaglutide is frequently used to help patients manage their weight over the long term. Additionally, it can be employed as part of a treatment plan that includes a calorie-restricted diet, physical activity, and treating at least one other condition that is related to obesity." - Anonymous Online Contributor

Unverified Answer

Are there any open slots for volunteers in this clinical trial?

"Correct, the information available on clinicaltrials.gov indicates that this study is actively looking for participants. The listing was created on 7/23/2021 and edited on 2/3/2022. They are hoping to recruit 150 patients from 2 locations." - Anonymous Online Contributor

Unverified Answer

What other drugs has Semaglutide been tested against in a clinical setting?

"At the moment, 59 clinical trials concerning Semaglutide are active with 27 of them being Phase 3 research. Even though a few of the investigations for Semaglutide are happening near Loma Linda, 3899 other locations are conducting studies regarding Semaglutide." - Anonymous Online Contributor

Unverified Answer

How many people are being included in this research project?

"Yes, as of February 3rd, 2022 this clinical trial is still seeking 150 participants from two different sites, as noted on clinicaltrials.gov" - Anonymous Online Contributor

Unverified Answer

What are the unique aspects of this clinical trial?

"There are 59 ongoing clinical trials for Semaglutide in 766 cities and 55 nations. The first study was completed in 2018 by Novo Nordisk A/S. It reached Phase 4 approval after involving 1387 patients. In the two years since, 123 more trials have finished." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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