Phase 4
Completed N=212
A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India
Source: ClinicalTrials.gov NCT05659537 ↗Enrolled (actual)
212
Serious AEs
0.5%
Results posted
Feb 2025
Primary outcomePrimary: Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths — 106; 1; 0 Participants
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths |
106; 1; 0 | — |
| PRIMARY Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events. |
13 | — |
| PRIMARY Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24 |
51.9; 0.5 | — |
| PRIMARY Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24 |
48 | — |
| SECONDARY Mean Change in HbA1c From Baseline to Week 24 |
-1.41 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of type 2 diabetes mellitus (T2DM) of at least 1-year duration currently treated with stable doses of oral antihyperglycemic medications with or without stable doses of basal or premix insulin for the last 3 months prior to screening
- Have hemoglobin A1c (HbA1c) greater than or equal to (≥) 7.5 percent (%) and less than or equal to (≤) 11.5%, both inclusive, at screening
- Have body mass index (BMI) ≥ 23 kilogram/square meter (kg/m²)
Exclusion Criteria
- A diagnosis of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes, or specific type of diabetes other than T2DM
- Been treated with antihyperglycemic medication like glucagon-like peptide receptor agonists (GLP-1 RA) or have a prior history of any contraindication to GLP-1 RA therapy within 3 months prior to screening or estimated glomerular filtration rate (eGFR) <15 milliliter/minute (ml/min)/1.73 square meter (m²)
- Participants have known hypersensitivity or allergy to dulaglutide or its excipients
- Participants are on systemic steroids for any period of more than 14 days
- Participants have severe gastrointestinal (GI) disease, including severe gastroparesis
- Participants have an active or untreated malignancy, except for successfully treated basal or squamous cell carcinoma
Data sourced from ClinicalTrials.gov (NCT05659537). 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.