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Glucagon

Phase 1

Type 1 Diabetes Mellitus With Hypoglycemia | Small molecule | Metabolic |United Therapeutics Corporation|Last Updated: Jan 15, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

Glucagon · 1 trial · 1 indication

Early Phase 1 1
NCT04712266A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 DiabetesType 1 Diabetes Mellitus With Hypoglycemia
COMPLETED15 Analytics
EARLY_PHASE1COMPLETED
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
Type 1 Diabetes Mellitus With HypoglycemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

hypoglycemic excursions
180-360 minutes post meal

\< 50mg/dl

hyperglycemic excursions
60-120 minutes post meal

\>150mg/dl

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insulin IVACTIVE_COMPARATORcalculated insulin rate
Insulin and Glucagon IVEXPERIMENTALcalculated molar ratio insulin:glucagon

Interventions

NameTypeDescription
GlucagonDRUGcalculated IV insulin:Glucagon molar ratio
InsulinDRUGcalculated IV Insulin dose infused at a constant rate
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female patients aged between 18 and 64 years (both inclusive) * Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit * Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit Exclusion Criteria: \-

Countries:United States
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Frequently asked questions about Glucagon

What is Glucagon used for in Type 1 Diabetes Mellitus With Hypoglycemia?

Glucagon is being investigated for use in Type 1 Diabetes Mellitus With Hypoglycemia, a condition where blood sugar levels drop dangerously low. It is a small molecule developed by United Therapeutics Corporation. The drug is in early clinical development, with one completed Phase 1 trial studying its effects on glucose levels.

What does Glucagon target?

Glucagon is a small molecule that works by raising blood glucose levels, counteracting the effects of insulin. It is being studied in Type 1 Diabetes Mellitus With Hypoglycemia to help manage severe hypoglycemic episodes. The drug's mechanism involves stimulating the liver to release stored glucose into the bloodstream.

Who makes Glucagon?

Glucagon is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on NASDAQ under the ticker UTHR. The company is conducting clinical research on this small molecule for the treatment of Type 1 Diabetes Mellitus With Hypoglycemia. The drug is currently in Phase 1 clinical development.

What phase is Glucagon in?

Glucagon is in Phase 1 clinical development, specifically an early Phase 1 trial. The study, NCT04712266, has been completed. It is an investigational drug and has not been approved by regulatory authorities. The trial enrolled 15 participants with Type 1 Diabetes Mellitus With Hypoglycemia in the United States.

What clinical trials is Glucagon in?

Glucagon has one completed clinical trial, NCT04712266, titled 'A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes.' This early Phase 1 study enrolled 15 participants with Type 1 Diabetes Mellitus With Hypoglycemia in the United States. The trial was active-controlled and randomized, though not double-blind.

Is Glucagon the same as other forms of glucagon?

Glucagon is a small molecule being developed by United Therapeutics Corporation for Type 1 Diabetes Mellitus With Hypoglycemia. It is distinct from other glucagon products on the market, which are typically peptides used for emergency hypoglycemia treatment. This investigational drug is in early clinical development and has not been approved.