A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India

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

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-18

Study Completion Date

2025-09-02

Brief Summary

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The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.

The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).

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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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Insulin Lispro-aabc + Insulin Glargine

Participants will receive insulin lispro-aabc in combination with insulin glargine administered by subcutaneous (SC) injection.

Group Type EXPERIMENTAL

Insulin Lispro-aabc

Intervention Type DRUG

Administered SC

Insulin Glargine

Intervention Type DRUG

Administered SC

Interventions

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Insulin Lispro-aabc

Administered SC

Intervention Type DRUG

Insulin Glargine

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY900014

Eligibility Criteria

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Inclusion Criteria

* Have Type 2 Diabetes Mellitus (T2DM) for ≥1 year prior to screening
* Treated for ≥90 days prior to screening with multiple daily injection (MDI) therapy

* on basal insulin or insulin glargine 100 U/mL \[Basaglar or Lantus\] or insulin glargin 300 U/mL, insulin determir, insulin degludec U-100, or neutral protamine Hagedorn (NPH) insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro 100 U/mL or 200 U/mL, insulin aspart, insulin glulisine, regular insulin, fast-acting insulin aspart), or
* premixed analog or human insulin regimens with any basal and bolus insulin
* May have been treated with up to 3 oral antihyperglycemic medications (OAMs) including metformin, sodium-glucose cotransporter (SGLT)-2 inhibitor in accordance with local regulations. The dose of all OAMs must have been stable for ≥90 days prior to screening
* Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening
* Body mass index ≤45.0 kg/m²
* Have access to a telephone, or alternative means for close monitoring/communications
* Have refrigeration at home or have ready access to refrigeration for storage of insulin therapy
* Have a regular wake-sleep schedule (awake-work during the day and sleep during the night)

Exclusion Criteria

* Having any other condition (including known drug or alcohol abuse, psychiatric disorder including eating disorder) that precludes the subject from following and completing the protocol
* Have been diagnosed, at any time, with type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes in adults
* Have hypoglycemia unawareness as judged by the investigator
* Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening
* Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening
* Have a known diagnosis of secondary diabetes (for example, diabetes caused by hemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy)
* Excessive insulin resistance defined as having received a total daily dose of insulin \>2.0 U/kg at the time of screening
* Have a history of or are being evaluated for bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve
* Have cardiovascular disease, within the past 6 months prior to screening, defined as stroke, decompensated heart failure (New York Heart Association Class III or IV), myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft
* History of renal transplantation
* Currently receiving renal dialysis
* Serum creatinine \>2.0 mg/dL (177 µmol/L) at screening
* Have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis or cirrhosis), or elevated liver enzyme measurements
* Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
* Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia, or any other traits known to interfere with measurement of HbA1
* Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations) in the investigator's opinion
* Have used thiazolidinediones, glucagon-like peptide 1 receptor agonist, or pramlintide within 90 days prior to screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No