The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Administered SC
Medlink Hospital Opp Someshwara Jain Temple
Ahmedabad, Ambavadi, India
Life Care Hospital and Research Centre
Bangalore, Karnataka, India
Grant Medical Foundation - Ruby Hall Clinic
Pune, Maharashtra, India
Akshay Hospital
Pune, Maharashtra, India
Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths
* 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.
Time frame: Baseline through Follow-up (up to 28 weeks)
Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.
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.
Time frame: Baseline through Follow-up (up to 28 weeks)
Percentage of Participants Reporting AEs and SAEs From Baseline to 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.
Time frame: Baseline through Week 24
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Lifepoint Multispecialty Hsptl
Wākad, Pune, India
Kovai Diabetes Speciality Center and Hospital
Coimbatore, Tamil Nadu, India
Virinchi Hospital
Hyderabad, Telangana, India
Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to 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.
Time frame: Baseline through Week 24
Mean Change in HbA1c From Baseline to 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.
Time frame: Baseline, Week 24