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NCT05659537CompletedPhase 4

A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

A 24-week Multicenter, Open-label, Single-arm Study to Evaluate Safety in Patients With Type 2 Diabetes Mellitus in India Treated With Dulaglutide

Source: ClinicalTrials.gov · Last updated 20 Feb 2025

Brief summary (registry, in English)

The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
212 (actual)
First submitted
15 Dec 2022
Start date
29 Dec 2022
Primary completion date
16 Jan 2024
Lead sponsor
Eli Lilly and Company
NCT number
NCT05659537

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 212
  • From 29 Dec 2022 to the primary completion date, 16 Jan 2024
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants are on systemic steroids for any period of more than 14 days

Other illness

  • A diagnosis of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes, or specific type of diabetes other than T2DM
  • Participants have known hypersensitivity or allergy to dulaglutide or its excipients
  • 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

Lab values

  • 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)

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medlink Hospital Opp Someshwara Jain Temple
Coordinator of this site? Confirm its status
AhmedabadIndiaUnknown status
Life Care Hospital and Research Centre
Coordinator of this site? Confirm its status
BangaloreIndiaUnknown status
Kovai Diabetes Speciality Center and Hospital
Coordinator of this site? Confirm its status
CoimbatoreIndiaUnknown status
Virinchi Hospital
Coordinator of this site? Confirm its status
HyderabadIndiaUnknown status
Akshay Hospital
Coordinator of this site? Confirm its status
PuneIndiaUnknown status
Grant Medical Foundation Ruby Hall Clinic
Coordinator of this site? Confirm its status
PuneIndiaUnknown status
Lifepoint Multispecialty Hsptl
Coordinator of this site? Confirm its status
WākadIndiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.