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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-29

Study Completion Date

2024-01-16

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dulaglutide

Intervention Type DRUG

Administered SC

Interventions

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Dulaglutide

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY2189265

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No