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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT05659537 (opens ClinicalTrials.gov in a new tab)Other id18550Other idH9X-IN-GBGR
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
212 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

India

Start
29 Dec 2022
Primary completion
16 Jan 2024
Completion
16 Jan 2024
First posted
21 Dec 2022
Last update posted
20 Feb 2025
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 4

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

    NCT05659537

    29 Dec 2022 to 16 Jan 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • DulaglutideDrug

Arms1

  • Experimental

    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 outcomes4

Outcomes the sponsor listed as primary.

  1. Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths

    Time frame · Baseline through Follow-up (up to 28 weeks)

    Registry description

    * 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.

  2. Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.

    Time frame · Baseline through Follow-up (up to 28 weeks)

    Registry description

    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.

  3. Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24

    Time frame · Baseline through Week 24

    Registry description

    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.

  4. Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24

    Time frame · Baseline through Week 24

    Registry description

    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 outcomes(1)

  1. Mean Change in HbA1c From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline through Follow-up (up to 28 weeks)

Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Deaths

GroupValue (Participants)
Dulaglutide106
Primary outcomeCount of participants· Baseline through Follow-up (up to 28 weeks)

Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events.

GroupValue (Participants)
Dulaglutide13
Primary outcomeNumber· Baseline through Week 24

Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24

GroupValue (percentage of participants)
Dulaglutide51.9
Primary outcomeCount of participants· Baseline through Week 24

Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24

GroupValue (Participants)
Dulaglutide48
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline, Week 24

Mean Change in HbA1c From Baseline to Week 24

GroupValue (Percentage of HbA1c)Spread
Dulaglutide-1.411.422

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
1.5 mg/0.75 mg Dulaglutide (Both Doses)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.0 / 1651 / 165100 / 165
1.5 mg Dulaglutide OnlyParticipants in this arm received SC injections of only 1.5 mg of dulaglutide QW over a 24-week treatment period.0 / 210 / 218 / 21
0.75 mg Dulaglutide OnlyParticipants in this arm received SC injections of only 0.75 mg of dulaglutide QW over a 24-week treatment period.0 / 140 / 146 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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