Recruiting
Phase 2

Metoclopramide

Sponsor:

Simon Fisher

Code:

NCT03970720

Conditions

Hypoglycemia Unawareness

Eligibility Criteria

Sex: All

Age: 20 - 60

Healthy Volunteers: Not accepted

Interventions

Metoclopramide

Placebo

Study Details

Brief 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.

Conditions

Hypoglycemia Unawareness

Study ID

NCT03970720

Start date

May 28, 2019

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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, uncontrolled hypertension, pheochromocytoma, seizure disorders, Parkinson's disease, use of neuroleptics or antipsychotics within 6 months, use of benzodiazepines within the last month, active or recent (last 14 days) use of monoamine oxidase inhibitors or opioids, active alcohol or drug abuse, or other sedatives
  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Metoclopramide

10 mg metoclopramide four times a day

Placebo

10 mg matching placebo capsules four times a day

Primary outcome measure

  • Change in Blood Glucagon [ Time Frame: 4 weeks ]
  • Change in Blood Epinephrine [ Time Frame: 4 weeks ]
  • Change in Blood Norepinephrine [ Time Frame: 4 weeks ]
  • Change in Blood Cortisol [ Time Frame: 4 weeks ]
  • Change in Blood Pancreatic Polypeptide [ Time Frame: 4 weeks ]
  • Change in Hypoglycemia Symptom Recognition [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Simon Fisher, MD, PhD

859-562-0473sjfi230@uky.edu

Karen M Shearer

859-323-7778Karen.Shearer@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40516

Contacts

Simon Fisher, MD, PhD

859-562-0473Simon.Fisher@uky.edu

Karen Shearer, HIT

8593237778Karen.Shearer@uky.edu

Principal Investigator:

Simon Fisher, MD, PhD

More Information

Sponsor

Simon Fisher

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • Type 1 Diabetes Mellitus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Simon Fisher on 2026-03-20.