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New treatment option for Hypoglycemia Unawareness
Official title Restoration of Hypoglycemia Awareness With Metoclopramide
ClinicalTrials.gov ID: NCT03970720
What this study is testing
What is Metoclopramide?
Metoclopramide is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for hypoglycemia unawareness.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 60
You may be able to join if
- people with Type 1 Diabetes Mellitus
- Diabetes duration \> 5 years
- Hemoglobin A1c ≤ 9%
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
You likely can't join if
- History of myocardial infarction, cardiac arrhythmia, congestive heart failure and coronary artery insufficiency
- History of stroke or brain disease
- History of genitourinary obstruction or urinary retention
- Advanced liver disease
- Active anemia with hemoglobin less than 11 g/dL
- Female in pregnancy or breastfeeding, or not able to practice effective contraception during the study period
See the full eligibility criteria
- people with Type 1 Diabetes Mellitus
- Diabetes duration \> 5 years
- Hemoglobin A1c ≤ 9%
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
- History of myocardial infarction, cardiac arrhythmia, congestive heart failure and coronary artery insufficiency
- History of stroke or brain disease
- History of genitourinary obstruction or urinary retention
- Advanced liver disease
- Active anemia with hemoglobin less than 11 g/dL
- Female in pregnancy or breastfeeding, or not able to practice effective contraception during the study period
- Uncontrolled mania or active major depressive disorder
- Previous allergic reaction or side effect to heparin use
- Contraindications to metoclopramide or conditions raising the risk for complication development to metoclopramide, such as hypersensitivity to metoclopramide, ongoing mechanical gastrointestinal obstruction...
- Participation in another study evaluating treatment for impaired awareness of hypoglycemia or hypoglycemia-associated autonomic failure in the last 30 days
- Current use of unblinded real-time Continuous Glucose Monitoring System
- Frequent need of acetaminophen administration
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.