A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India
- Registration Number
- NCT05659537
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dulaglutide Dulaglutide * Participants received once-weekly (QW) subcutaneous (SC) dulaglutide injections for 24 weeks, starting with either 1.5 milligrams (mg) as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator). * For participants reporting gastrointestinal adverse events (GI AEs) after starting the 1.5 mg dulaglutide dose, the investigator reduced the dose to 0.75 mg for 2 to 3 weeks. Thereafter, the 1.5 mg dose was reintroduced.
- Primary Outcome Measures
Name Time Method Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths Baseline through Follow-up (up to 28 weeks) * An AE was any untoward medical occurrence in a participant who was administered an investigational product that did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE that occurred post-dose or was present prior to dosing and became more severe post-dose.
* An SAE was any AE from the study that resulted in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that might not have been immediately life-threatening or resulted in death or hospitalization but might have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.
* A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events. Baseline through Follow-up (up to 28 weeks) Hypoglycemia events were defined as those with blood glucose (BG) levels less than (\<) 70 milligrams per deciliter (mg/dL). Severe hypoglycemia events were defined as those with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. These events could be associated with sufficient neuroglycopenia to induce seizures or coma. The total number of participants who experienced hypoglycemia events, including severe hypoglycemia, was summarized cumulatively.
Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24 Baseline through Week 24 The percentage of participants who reported AEs and SAEs was calculated by dividing the total number of affected participants by the number of participants analyzed, then multiplying by 100. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.
Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24 Baseline through Week 24 The number of participants who experienced at least one or more GI AEs of nausea, vomiting, and diarrhoea were summarized cumulatively. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.
- Secondary Outcome Measures
Name Time Method Mean Change in HbA1c From Baseline to Week 24 Baseline, Week 24 HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The mean change in HbA1c levels was calculated using descriptive analysis, with baseline HbA1c as a covariate. Missing endpoints were addressed using the last observation carried forward (LOCF) method.
Trial Locations
- Locations (7)
Life Care Hospital and Research Centre
🇮🇳Bangalore, Karnataka, India
Akshay Hospital
🇮🇳Pune, Maharashtra, India
Virinchi Hospital
🇮🇳Hyderabad, Telangana, India
Lifepoint Multispecialty Hsptl
🇮🇳Wakad, Pune, India
Grant Medical Foundation - Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India
Medlink Hospital Opp Someshwara Jain Temple
🇮🇳Ahmedabad, Ambavadi, India
Kovai Diabetes Speciality Center and Hospital
🇮🇳Coimbatore, Tamil Nadu, India