Your session is about to expire
← Back to Search
Anti-diabetic agent
Metformin for High Blood Sugar After Joint Replacement
Phase 4
Recruiting
Led By Ryland Kagan
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing total hip or total knee arthroplasty, including elective, primary, and revision surgeries
Be older than 18 years old
Must not have
Type 1 diabetes
Current alcohol abuse within 30 days of surgery (>4 standard servings daily for men, >3 standard servings daily for women)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to see if metformin can help control blood sugar in patients after hip or knee replacement surgery. The study will look at how feasible it is to conduct a larger trial in terms of
Who is the study for?
This trial is for individuals with high blood sugar who are undergoing total hip or knee replacement surgery. It's a pilot study to see if it's possible to do a larger trial on how well metformin controls blood sugar after these surgeries.
What is being tested?
The study is testing the drug metformin against a placebo (a pill without any medicine) in patients having joint replacement surgery. The goal is to gather initial data on whether metformin helps control blood sugar levels post-surgery.
What are the potential side effects?
Metformin can cause side effects like stomach upset, diarrhea, nausea, and loss of appetite. Rarely, it may lead to low blood sugar or a serious condition called lactic acidosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a hip or knee replacement surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have Type 1 diabetes.
Select...
I have not abused alcohol in the last 30 days.
Select...
I have severe heart failure.
Select...
My kidney function is significantly reduced.
Select...
My liver is severely damaged (Child-Pugh B or C).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of appropriate study drug administration
Rate of participant adherence to trial intervention per protocol
Rate of participant enrollment
+1 moreSecondary study objectives
90-day Rate of periprosthetic joint infection
90-day Rate of surgical site infection
Hospital length of stay
+2 moreSide effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Oral metformin hydrochloride
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,157 Total Patients Enrolled
3 Trials studying Diabetes
376 Patients Enrolled for Diabetes
Ryland KaganPrincipal InvestigatorOregon Health and Science University