CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 536 enrolled
Drug / intervention
LY2963016 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Type 2 diabetes mellitus diagnosed per WHO classification
  • ✓Currently on 2 or more oral antidiabetic medications at stable doses for at least 12 weeks
  • ✓HbA1c between 7.0% and 11.0%
  • ✓Body mass index ≤35 kg/m²
Key exclusion· 12
  • ✕Insulin therapy used in the past 1 year (except short-term for acute conditions up to 4 weeks)
  • ✕GLP-1 receptor agonist use within 90 days
  • ✕Traditional herbal or patent medicine with anti-hyperglycemic effects within 3 months
  • ✕More than one episode of severe hypoglycemia within 6 months

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

Search/NCT03338010
NCT03338010Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus® in Adult Chinese Patients With Type 2 Diabetes Mellitus

Eli Lilly and Company·interventional·Posted Nov 9, 2017·Updated May 25, 2021

In Brief

A Phase 3 clinical trial evaluating LY2963016 and Lantus® for Type 2 Diabetes. Completed, enrolled 536 participants across 32 sites.

Detailed Summary

The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more oral antihyperglycemic medications (OAMs). Participants will continue their OAMs throughout the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 9, 2017
Enrollment StartMar 22, 2018
Primary CompletionMar 18, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.6 years ago

Interventions

LY2963016drug

Administered SC

Lantus®drug

Administered SC