Restoration of Hypoglycemia Awareness With Metoclopramide

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Simon Fisher
Study ID
NCT03970720
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hypoglycemia Unawareness

Eligibility Criteria

Sex
ALL
Age
20 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Metoclopramide — DRUG
    10 mg metoclopramide four times a day
  • Placebo — DRUG
    10 mg matching placebo capsules four times a day

Study Details

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.

Key Dates

Start date
May 28, 2019
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Blood Glucagon [ Time Frame: 4 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40516
Simon Fisher, MD, PhD
[email protected]
859-562-0473
Karen Shearer, HIT
[email protected]
8593237778
Simon Fisher, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132-

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