Phase 3
Completed N=536
A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03338010 ↗Enrolled (actual)
536
Serious AEs
7.8%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®) — -1.27; -1.23 Percentage of HbA1c — p=0.545
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®) |
-1.27; -1.23 | 0.545 |
| SECONDARY Change From Baseline in HbA1c (Lantus® to LY2963016) |
-1.27; -1.23 | 0.545 |
| SECONDARY Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values |
-48.7; -49.7; -56.3; -52.7; -43.2; -39.9 | 0.602 |
| SECONDARY Percentage of Participants With HbA1c <7% at Week 24 |
43.7; 44.9 | 0.846 |
| SECONDARY Percentage of Participants With HbA1c ≤6.5% at Week 24 |
23.4; 16.5 | 0.098 |
| SECONDARY Change From Baseline in Glycemic Variability of Fasting Blood Glucose |
-2.17; -2.49; -4.1; -4.5 | 0.767 |
| SECONDARY Basal Insulin Dose Units Per Day |
16.0; 15.7 | 0.750 |
| SECONDARY Change From Baseline in Basal Insulin Dose Units Per Day |
7.0; 6.8 | 0.750 |
| SECONDARY Change From Baseline in Body Weight |
1.1; 1.2 | <0.001 sig |
| SECONDARY Insulin Treatment Satisfaction Questionnaire (ITSQ) |
89.36; 90.31; 83.70; 87.69; 89.07; 90.86 | 0.500 |
| SECONDARY Number of Participants With Detectable Anti-Glargine Antibodies |
69; 31 | 0.639 |
| SECONDARY Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year) |
1.37; 1.15; 0.47; 0.39 | 0.143 |
Eligibility Criteria
Inclusion Criteria
- Have T2DM based on the disease diagnostic criteria World Health Organization (WHO) classification.
- Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening.
- Have a HbA1c ≥7.0% and ≤11.0%.
- Body mass index (BMI) ≤35 kilograms per meter squared.
Exclusion Criteria
- Have used insulin therapy (outside of pregnancy) anytime in the past 1 year, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks.
- Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
- Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
- Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- Have had ≥2 emergency room visits or hospitalizations due to poor glucose control.
- Have known hypersensitivity or allergy to Lantus® or its excipients.
- Are receiving chronic systemic glucocorticoid therapy at pharmacological doses or have received such therapy within 4 weeks immediately preceding screening.
- Have obvious signs or symptoms, or laboratory evidence, of liver disease.
- Have one of the following concomitant diseases: significant cardiac or gastrointestinal disease.
- Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 milligrams per deciliter.
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
- Participants with active cancer or personal history of cancer within the previous 5 years.
- Are pregnant or intend to become pregnant during the course of the study.
- Are women who are breastfeeding.
Data sourced from ClinicalTrials.gov (NCT03338010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.