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Anti-diabetic agent
High-Dose Metformin for Type 2 Diabetes (PRECISE_T2D Trial)
Phase < 1
Recruiting
Led By Shylaja Srinivasan, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Provider diagnosis of T2D
Taking regular metformin (not extended-release formula)
Must not have
Known history of ongoing renal or hepatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a higher dose of metformin works better than standard dose to treat diabetes.
Who is the study for?
This trial is for young people aged 8-21 with Type 2 Diabetes who speak English or Spanish. They must be able to wear a CGM device for 6 weeks, have been on a stable medication regimen for at least two weeks, and take regular metformin. Those with significant mental illness, ongoing renal or hepatic disease, or pancreatic autoantibody positivity cannot participate.
What is being tested?
The study is testing the effects of two different doses of metformin in youth with Type 2 Diabetes: the standard dose (1000mg twice daily) versus a higher dose (1350mg twice daily). Participants will compare these dosages over the course of the study.
What are the potential side effects?
Metformin can cause side effects like stomach upset, diarrhea, nausea and vomiting, gas, weakness, headache, muscle pain and low blood sugar levels. The risk may increase slightly with higher doses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type 2 diabetes.
Select...
I am currently taking standard metformin.
Select...
I am between 8 and 21 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a known ongoing kidney or liver disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)
Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM)
Secondary study objectives
Co-efficient of variation of glucose
Glucose management indicator
Glycemic Change
+6 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
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
1350mg metformin twice per day
Group II: Active ComparatorActive Control1 Intervention
1000mg metformin twice per day
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?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,433 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,930 Total Patients Enrolled
Shylaja Srinivasan, MDPrincipal InvestigatorUniversity of California, San Francisco