A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2022-10-17

Brief Summary

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The main purpose of this study is to evaluate the effect of study drug known as LY3209590 compared to insulin glargine administered in participants with type 2 diabetes mellitus (T2DM). Side effects and tolerability will be documented. The study will last almost six months and 21 visits for each participant including screening period.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Insulin Glargine (Period 1)

Insulin glargine administered subcutaneously (SC).

Group Type ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type DRUG

Administered SC

LY3209590 (Period 2)

LY3209590 administered SC.

Group Type EXPERIMENTAL

LY3209590

Intervention Type DRUG

Administered SC

Interventions

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Insulin Glargine

Administered SC

Intervention Type DRUG

LY3209590

Administered SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 1 year prior to screening
* Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
* Be treated for T2DM with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening

Exclusion Criteria

* Have an abnormality in the 12-lead ECG
* Have a supine blood pressure at screening
* Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5x upper limit of normal (ULN)
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (except T2DM and controlled thyroid disease), haematological, or neurological disorders
* Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy
* Have an average weekly alcohol intake

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No