Phase 4
N=304
A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT04153981 ↗Enrolled (actual)
304
Serious AEs
0.4%
Results posted
Feb 2024
Primary outcome: Primary: Number or Participants With Hypoglycemic Events — 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin Glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number or Participants With Hypoglycemic Events |
10 | — |
| SECONDARY Basal Insulin Dose |
0.30 | — |
| SECONDARY Change From Baseline in Body Weight |
-0.5 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.641; -0.860 | — |
| SECONDARY Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values |
-38.7; -54.3; -32.9; -43.6; -29.4; -45.7 | — |
| SECONDARY Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ) |
-0.3; -0.3; -0.2; -0.3; -0.3 | — |
Summary
The reason for this study is to see if insulin glargine is safe in participants with type 2 diabetes mellitus (T2DM) in India.
Eligibility Criteria
Inclusion Criteria
- Have T2DM based on the disease diagnostic criteria from the World Health Organization (WHO) classification for at least 6 months before screening.
- Have been receiving glucagon-like peptide-1 receptor agonist (GLP-1 RA) or ≥2 oral antihyperglycemic medication (OAMs) at stable doses for 90 days prior to screening.
- Have an HbA1c level ≥7.0% and 2 units per kilogram).
- Have a history or diagnosis of human immunodeficiency virus infection, hepatitis B and C.
- Have comorbidities of unstable angina, cardiac failure (Stage III or IV as per New York Heart Association guidelines) or renal failure (estimated glomerular filtration rate <30 milliliters/minute/meter squared).
- Are pregnant or intend to become pregnant during the course of the study; or are sexually active women of child-bearing potential not actively practicing birth control by a medically acceptable method as determined by the investigator.
- Is a woman who is breastfeeding.
- Have participated within the last 30 days in a clinical trial involving an investigational product other than the LY2963016. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
- Have previously completed or withdrawn from this study or any other study investigating LY2963016. This exclusion criterion does not apply to participants who are rescreened prior to baseline visit.
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Are unwilling or unable to comply with the use of a glucometer.
Data sourced from ClinicalTrials.gov (NCT04153981). 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.