Restoration of Hypoglycemia Awareness With Metoclopramide
Who is this study for? Adult patients with type 1 diabetes
What treatments are being studied? Metoclopramide
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: f
View:
• Subjects 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
Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Utah
University of Utah
COMPLETED
Salt Lake City
Contact Information
Primary
Simon Fisher, MD, PhD
sjfi230@uky.edu
859-562-0473
Backup
Karen M Shearer
Karen.Shearer@uky.edu
859-323-7778
Time Frame
Start Date: 2019-05-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 36
Treatments
Experimental: T1DM - Unaware: Metoclopramide
T1DM participants with hypoglycemia unawareness determined by a hypoglycemic clamp study will receive 10 mg metoclopramide four times a day during the four-week intervention period.
Placebo_comparator: T1DM - Unaware: Placebo
T1DM participants with hypoglycemia unawareness determined by a hypoglycemic clamp study will receive 10 mg matching placebo capsules four times a day during the four-week intervention period.
Placebo_comparator: T1DM - Aware: Placebo
T1DM participants with hypoglycemia awareness determined by a hypoglycemic clamp study will receive 10 mg matching placebo capsules four times a day during the four-week intervention period.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Simon Fisher