Metoclopramide for Hypoglycemia Unawareness
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Simon Fisher
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
What data supports the effectiveness of the drug Metoclopramide for hypoglycemia unawareness?
The research does not provide direct evidence supporting the effectiveness of Metoclopramide for hypoglycemia unawareness. However, Metoclopramide is known to stimulate prolactin release, which may have indirect effects on hormone regulation.
578910Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot participate if you have used neuroleptics or antipsychotics in the last 6 months, benzodiazepines in the last month, or monoamine oxidase inhibitors or opioids in the last 14 days.
How does the drug metoclopramide differ from other treatments for hypoglycemia unawareness?
Metoclopramide is unique because it is primarily known for its ability to enhance gastric emptying and increase gastrointestinal motility, which is different from typical treatments for hypoglycemia unawareness. While it is not a standard treatment for this condition, its use in this context may be novel due to its effects on the digestive system, potentially influencing blood sugar levels.
12346Eligibility Criteria
This trial is for adults with Type 1 Diabetes Mellitus, who have had diabetes for over 5 years and are experiencing low blood sugar without the usual warning signs. Participants must not be pregnant or breastfeeding, should not have severe heart, liver, or brain conditions, and cannot be on certain medications like antipsychotics or opioids.Inclusion Criteria
I have Type 1 Diabetes Mellitus.
I have had diabetes for more than 5 years.
Exclusion Criteria
My liver disease is in an advanced stage.
My hemoglobin level is below 11 g/dL.
I have a history of heart issues, including heart attack, irregular heartbeat, heart failure, or poor blood flow in my heart arteries.
I cannot take metoclopramide due to allergies, certain health conditions, or recent use of specific medications.
I have had issues with blocked urine flow or not being able to urinate.
I do not have uncontrolled mania or active major depression.
I have had a stroke or brain disease in the past.
I am not pregnant, breastfeeding, and can use effective birth control during the study.
Participant Groups
The study is testing whether Metoclopramide can help people with type 1 diabetes become more aware of when their blood sugar gets too low. It involves comparing Metoclopramide to a placebo (a substance with no active drug) to see if it reduces episodes of low blood sugar.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: T1DM - Unaware: MetoclopramideExperimental Treatment1 Intervention
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.
Group II: T1DM - Aware: PlaceboPlacebo Group1 Intervention
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.
Group III: T1DM - Unaware: PlaceboPlacebo Group1 Intervention
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.
Metoclopramide is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Metoclopramide for:
- Gastroesophageal reflux disease (GERD)
- Diabetic gastroparesis
- Prevention of chemotherapy-induced nausea and vomiting
🇪🇺 Approved in European Union as Metoclopramide for:
- Symptomatic treatment of nausea and vomiting
- Prevention of delayed chemotherapy-induced nausea and vomiting
- Treatment of gastroparesis
🇨🇦 Approved in Canada as Metoclopramide for:
- Symptomatic treatment of nausea and vomiting
- Prevention of chemotherapy-induced nausea and vomiting
- Treatment of gastroparesis
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of KentuckyLexington, KY
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Who is running the clinical trial?
Simon FisherLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Hypglycaemia in paediatric anaesthesia: The influence of metoclopramide and oral maltose in paediatric surgical patients. [2019]A safe and effective way to prevent the development of hypoglycaemia in young children during general anaesthesia is to give drinks sweetened with maltose 2 hours before operation. Metoclopramide (Maxolon) is injected intramuscularly to hasten absorption. The postoperative blood sugar in the maltose-treated group (28 patients) was 100+/-22-21 mg/ml (5-5+/-1-232 mmol/litre) and significantly higher ( P less than 0-0005) than in the starved group (22 patients).
Metoclopramide: a dopamine receptor antagonist. [2013]A dopamine receptor antagonist, metoclopramide has unique properties of increasing lower esophageal sphincter pressure and increasing the rate of gastric emptying. These gastrointestinal motility actions are useful in the treatment of diabetic gastroparesis and severe gastroesophageal reflux and in postoperative situations involving visceral atony. Metoclopramide is a useful adjunctive drug for intestinal intubation and radiologic examination. It has also been used intravenously to control the nausea and vomiting of intensive cancer chemotherapy, such as with cisplatin. Metoclopramide is a powerful antiemetic because of its combined actions on the chemoreceptor trigger zone and intestinal motility. This agent is generally not intended for long-term use. The oral preparations are recommended for four to 12 weeks of therapy. Use of parenteral metoclopramide should be limited to one or two days. The most common adverse reactions are restlessness, drowsiness, fatigue and lassitude. Extrapyramidal symptoms occur rarely and only with high dosage or prolonged use.
Failure of metoclopramide to control emesis or nausea due to stressful angular or linear acceleration. [2013]Orally administered metoclopramide (REGLAN) at doses of 10 or 20 mg, 75 min prior to either stressful linear acceleration (parabolic flight) or cross-coupled accelerative semicircular canal stimulation in a rotating chair was evaluated for its ability to prevent emesis or nausea II, respectively. Although metoclopramide is an effective antiemetic agent that enhances gastric emptying and prevents cancer chemotherapy-induced emesis, we were unable to demonstrate any significant (p less than 0.05) effects of this drug on motion sickness.
[Antiemetic combination of metoclopramide and methylprednisolone for cisplatin-induced vomiting]. [2013]An antiemetic combination of metoclopramide and methylprednisolone was administered to 16 lung cancer patients receiving cisplatin (80 cmg/m2) alone or in combination with other drugs. Metoclopramide was administered four times intravenously at a dose of 1.5 mg/kg. Methylprednisolone was administered three times intravenously at a dose of 125 mg. Sixteen patients received a total of 34 chemotherapy courses. No vomiting occurred in 70% of 34 chemotherapy courses and mild emesis (one or two vomiting episodes) occurred in 18% of chemotherapy courses. Side effects were minimal and included mild sleepiness (nine patients), diarrhea (three patients), and hiccups (three patients). It is concluded that a combination of metoclopramide and methylprednisolone is very effective in preventing cisplatin-induced vomiting.
The effects of arginine, insulin and metoclopramide on growth hormone, prolactin and cortisol release in children. [2019]The growth hormone (GH) and prolactin (PRL) responses to metoclopramide (MCP) were compared to those with arginine and insulin-induced hypoglycaemia in eight children. While a significant rise in GH release after stimulation with arginine and insulin occurred in all subjects (P less than 0.05), no significant increase after MCP ingestion was observed. Metoclopramide, a dopamine antagonist, stimulated PRL release in all children, while arginine and insulin-induced hypoglycaemia stimulation tests showed variable PRL responses. A statistically significant increase in cortisol secretion 5 h following MCP was observed (trend test, Cox & Stuart, 1955) (P less than 0.05), but the plasma concentration at this time was still within the normal range. Metoclopramide stimulation is not a suitable test for growth hormone deficiency in children.
Review of a new gastrointestinal drug--metoclopramide. [2013]The pharmacology, pharmacokinetics, therapeutic and diagnostic uses, toxicity, adverse reactions, and contraindications of metoclopramide are reviewed. Metoclopramide enhances the rate of gastric emptying by (1) augmenting esophageal peristalsis, gastric antral contractions, and small intestine transit time and (2) increasing resting pressures of the lower esophageal and pyloric sphincters. The drug does not stimulate gastric acid secretions. The injectable form is approved for use to facilitate intubation of the small intestine and the passage of barium into the intestine for radiographic procedures. Tablets are approved for the treatment of symptoms associated with diabetic gastroparesis. The drug has been used in the treatment of vomiting of various etiologies. The side effects of metoclopramide are usually mild, transient, and reversible with discontinuation of the drug. They include drowsiness, GI disturbances, extrapyramidal reactions, and increased lactation. Metoclopramide should not be given in combination with MAO inhibitors, tricyclic antidepressants, sympathomimetic amines, or to patients with pheochromocytoma, GI hemorrhage, obstruction, or perforation. Metoclopramide appears to be an effective drug in stimulating the mobility of the upper gastrointestinal tract without increasing gastric secretions. Further studies are needed to assess its value in the treatment of vomiting secondary to anesthesia and chemotherapy, and to assess its precise role in the treatment of diabetic gastroparesis.
Hypoglycemia unawareness is associated with reduced adherence to therapeutic decisions in patients with type 1 diabetes: evidence from a clinical audit. [2022]Hypoglycemia unawareness increases severe hypoglycemia risk. Hypoglycemia avoidance restores awareness, but it is difficult to sustain. We compared adherence to treatment changes by awareness status.
Successful administration of intranasal glucagon in the out-of-hospital environment. [2013]We present a case of successful prehospital treatment of hypoglycemia with intranasal (IN) glucagon. Episodes of hypoglycemia can be of varying severity and often requires quick reversal to prevent alteration in mental status or hypoglycemic coma. Glucagon has been shown to be as effective as glucose for the treatment of hypoglycemia. The inability to obtain intravenous (IV) access often impairs delivery of this peptide and is therefore frequently given via the intramuscular (IM) route. Intranasal administration of glucagon has been shown to be as effective as the IV route and may be used for rapid correction of hypoglycemic episodes where IV access is difficult or unavailable and IM administration is undesirable. We describe the first documentation in the peer-reviewed literature of the successful treatment and reversal of an insulin-induced hypoglycemic episode with IN glucagon in the prehospital setting. We also present a review of the literature regarding this novel medication administration route.
Usability of Nasal Glucagon Device: Partially Randomized Caregiver and Third-Party User Experience Trial with Simulated Administration at a Japanese Site. [2020]Glucagon is the only approved medicine for severe hypoglycemia available for caregivers of people with diabetes. Nasal glucagon (NG) was recently approved in the USA as a needle-free, ready-to-use alternative to injectable glucagon. This simulated user experience study in Japan compared NG and intramuscular glucagon (IMG) administration by caregivers, and NG administration by untrained third parties.
Glucagon: Its evolving role in the management of hypoglycemia. [2022]More than 10% of the United States population has diabetes, characterized by hyperglycemia. Insulin and other agents used to treat diabetes predispose people to hypoglycemia, which can be life threatening. Glucagon is an emergency medication that can save lives by quickly raising glucose in people who are unconscious or unable to consume glucose due to severe hypoglycemia. Although glucagon has been commercially available since 1960, earlier formulations required reconstitution of a dry powder with diluent immediately prior to injection, due to lack of long-term stability once reconstituted. Glucagon has been underutilized due to the lack of confidence or ability to administer in emergency situations. More recently, new formulations including a nasal powder glucagon and liquid-stable glucagon have become available. This article discusses the evidence surrounding new glucagon formulations compared with the original glucagon emergency kit including ease of use, efficacy, and safety with a focus on important patient counseling points and relevant clinical information on hypoglycemia.