← Human Trials & Peer-Reviewed Studies
A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk
Plain-language guide to NCT03730662: phase 3 randomized trial of Tirzepatide and Insulin Glargine, 2002 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03730662
- Phase
- phase 3
- Status
- completed
- Start
- 2018-11-20
- Completion (planned or actual)
- 2021-01-22
- Participants
- 2002 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Tirzepatide and Insulin Glargine.
The study will last about 108 weeks and may include up to 30 visits.
It had four arms (groups): one (experimental), one (experimental), one (experimental) and Insulin Glargine (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 2002 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have been diagnosed with type 2 diabetes mellitus (T2DM). Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening.
The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have had chronic or acute pancreatitis any time prior to study entry; have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.
The Tirzepatide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.
It started in 2018-11-20 with completion listed for 2021-01-22.
It ran at 216 sites in United States (74), Canada (19), Argentina (15), Australia (15), Spain (12) and Poland (11).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) ([amount hidden]).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Tirzepatide and Insulin Glargine in 2002 people.
With 2002 participants it is a large trial for this field.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Tirzepatide compound page and the Insulin Glargine compound page, all human trials.
Our Notes on the Compounds
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.