Study S000183

A Randomized, Placebo-Controlled, Crossover Study to Investigate the Effect of Once-Weekly Tirzepatide on the Counter-Regulatory Response to Hypoglycemia in Patients With Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04050553
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 42
Start: 2020-02-24
Primary completion: 2022-01-25
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus, Type 2; Hypoglycemia
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:I8F-MC-GPHG; EUDRACT_NUMBER:2019-001360-29; NIH:2019

Registered primary outcomes

Change in Mean Glucagon Concentration During Induced Hypoglycemia From Target Plasma Glucose (PG) Concentration of 100 Milligrams Per Deciliter (mg/dL) to a Nadir Target of 45 mg/dL [Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level.]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0015435	Counterregulatory response to hypoglycemia during a hypoglycemic clamp in people with type 2 diabetes treated with tirzepatide. Pieber TR, Frontiers in endocrinology	2025	Randomized trial	PMID 40964167 DOI	cites ClinicalTrials.gov:NCT04050553; registry reference DERIVED:40964167