Trial Outcomes & Findings for A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India (NCT NCT05659537)

Last Updated: 2025-02-20

Results Overview

* 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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

212 participants

Primary outcome timeframe

Baseline through Follow-up (up to 28 weeks)

Results posted on

2025-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	212
Overall Study Received at Least One Dose of Dulaglutide (Safety Population)	200
Overall Study Received at Least One Dulaglutide Dose and Had at Least One HbA1c Measurement Post-study Treatment	189
Overall Study COMPLETED	185
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	5
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	13
Overall Study Migration from the Study Site Such That Follow Up Visits are not Possible	3
Overall Study Participant had low absolute neutrophil count value	1
Overall Study Participant was suffering from anaemia	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dulaglutide n=189 Participants * Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator). * For participants reporting 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.
Age, Continuous	54.1 years STANDARD_DEVIATION 10.45 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	189 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	189 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment India	189 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through Follow-up (up to 28 weeks)

Population: All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20 percent (%). However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20 %. Hence, outcomes are reported for the overall dulaglutide treatment group.

Outcome measures

Outcome measures
Measure	Dulaglutide n=189 Participants * Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator). * For participants reporting 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.
Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths TEAEs	106 Participants
Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths SAEs	1 Participants
Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths Deaths	0 Participants

PRIMARY outcome

Timeframe: Baseline through Follow-up (up to 28 weeks)

Population: All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20%. However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20%. Hence, outcomes are reported for the overall dulaglutide treatment group.

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.

Outcome measures

Outcome measures
Measure	Dulaglutide n=189 Participants * Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator). * For participants reporting 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.
Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.	13 Participants

PRIMARY outcome

Timeframe: Baseline through Week 24

Population: All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20%. However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20%. Hence, outcomes are reported for the overall dulaglutide treatment group.

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.

Outcome measures

Outcome measures
Measure	Dulaglutide n=189 Participants * Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator). * For participants reporting 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.
Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24 AEs	51.9 percentage of participants
Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24 SAEs	0.5 percentage of participants

PRIMARY outcome

Timeframe: Baseline through Week 24

Population: All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20%. However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20%. Hence, outcomes are reported for the overall dulaglutide treatment group.

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.

Outcome measures

Outcome measures
Measure	Dulaglutide n=189 Participants * Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator). * For participants reporting 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.
Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24	48 Participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All participants who received at least one dulaglutide dose and had at least one HbA1c measurement post-study treatment. As prespecified in the statistical analysis plan, the primary and secondary outcomes were planned to be analyzed and reported by dose level only if the proportion in each arm was more than 20%. However, the percentage in the 1.5 mg only or 0.75 mg only dulaglutide arm was lower than 20%. Hence, outcomes are reported for the overall dulaglutide treatment group.

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.

Outcome measures

Outcome measures
Measure	Dulaglutide n=189 Participants * Participants received QW dulaglutide SC injections for 24 weeks, starting with either 1.5 mg as combination therapy or 0.75 mg as combination therapy or monotherapy (at the discretion of the investigator). * For participants reporting 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.
Mean Change in HbA1c From Baseline to Week 24	-1.41 Percentage of HbA1c Standard Deviation 1.422

Adverse Events

1.5 mg/0.75 mg Dulaglutide (Both Doses)

Serious events: 1 serious events

Other events: 100 other events

Deaths: 0 deaths

1.5 mg Dulaglutide Only

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

0.75 mg Dulaglutide Only

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1.5 mg/0.75 mg Dulaglutide (Both Doses) n=165 participants at risk Participants in this arm received SC injections of both 1.5 mg and 0.75 mg dulaglutide QW doses at different points during the 24-week treatment period.	1.5 mg Dulaglutide Only n=21 participants at risk Participants in this arm received SC injections of only 1.5 mg of dulaglutide QW over a 24-week treatment period.	0.75 mg Dulaglutide Only n=14 participants at risk Participants in this arm received SC injections of only 0.75 mg of dulaglutide QW over a 24-week treatment period.
Injury, poisoning and procedural complications Road traffic accident	0.61% 1/165 • Number of events 1 • From baseline until safety follow-up (up to 28 weeks) All participants who had received at least one dose of dulaglutide.	0.00% 0/21 • From baseline until safety follow-up (up to 28 weeks) All participants who had received at least one dose of dulaglutide.	0.00% 0/14 • From baseline until safety follow-up (up to 28 weeks) All participants who had received at least one dose of dulaglutide.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60