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Isoglycemic Clamp

Phase 1

Diabetes | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Jul 23, 2015

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Isoglycemic Clamp · 1 trial · 1 indication

Phase 1 1
NCT01152242Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)Diabetes
COMPLETED36 Analytics
PHASE1COMPLETED
Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
Baseline and 30 hours
Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine
Baseline and 30 hours

Secondary Endpoints

Part I: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR and GIRmax over the duration of action of glargine
Baseline and 30 hours
Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
Baseline and 30 hours
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1ACTIVE_COMPARATORPart I of the trial
Part 2ACTIVE_COMPARATORPart II of the trial

Interventions

NameTypeDescription
Isoglycemic ClampDRUGIsoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)
Comparator: insulin glargineDRUGInsulin glargine at 0.4 U/kg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersNo

Inclusion Criteria: Part 1: * Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit * Patient has a clinical diagnosis of type 1 diabetes * Patient must have been treated with insulin since diagnosis and be on a stable dose of insulin * Patient has a Body Ma...

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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about Isoglycemic Clamp

What is Isoglycemic Clamp used for in Diabetes?

Isoglycemic Clamp is an investigational small molecule being developed by Merck & Company, Inc. for the treatment of Diabetes. It is currently in Phase 1 clinical development. The drug is being studied for its pharmacodynamic and pharmacokinetic effects in patients with diabetes.

What does Isoglycemic Clamp target?

The molecular target of Isoglycemic Clamp has not been disclosed. It is a small molecule being developed for Diabetes, but its specific mechanism of action is not publicly available. The drug is currently in Phase 1 clinical trials.

Who makes Isoglycemic Clamp?

Isoglycemic Clamp is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for the treatment of Diabetes.

What phase is Isoglycemic Clamp in?

Isoglycemic Clamp is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is Isoglycemic Clamp in?

Isoglycemic Clamp has one completed clinical trial, NCT01152242, titled "Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)". This Phase 1 study enrolled 36 male participants aged 18 years and older with Diabetes. The trial was active-controlled but not randomized or double-blinded.

Is Isoglycemic Clamp the same as 0000-168?

Isoglycemic Clamp is also known as 0000-168, as referenced in the clinical trial title NCT01152242. The trial evaluates the pharmacodynamic and pharmacokinetic variability of this basal insulin product in patients with Diabetes.