CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 475 enrolled
Drug / intervention
Tirzepatide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04039503
NCT04039503Phase 3Completed
CompareCT.gov

Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide Versus Placebo in Patients With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

Eli Lilly and Company·interventional·Posted Jul 31, 2019·Updated Jan 12, 2022

In Brief

A Phase 3 clinical trial evaluating Tirzepatide and Placebo for Type 2 Diabetes. Completed, enrolled 475 participants across 48 sites in 8 countries.

Detailed Summary

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesCzechia, Germany, Japan, Poland, Puerto Rico, Slovakia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 31, 2019
Enrollment StartAug 30, 2019
Primary CompletionDec 22, 2020
Study CompletionJan 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.9 years ago

Interventions

Tirzepatidedrug

Administered SC as add-on to the pre-trial background medication.

Placebodrug

Administered SC as add-on to the pre-trial background medication.