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

Last updated: April 16, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

Insulin Lispro-aabc

Insulin Glargine

Clinical Study ID

NCT06370715
18269
I8B-MC-ITTA
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 insulinglargin 300 U/mL, insulin determir, insulin degludec U-100, or neutralprotamine Hagedorn (NPH) insulin) in combination with at least 1 prandialinjection of bolus insulin (insulin lispro 100 U/mL or 200 U/mL, insulinaspart, 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 accordancewith local regulations. The dose of all OAMs must have been stable for ≥90 daysprior 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 ofinsulin therapy

  • Have a regular wake-sleep schedule (awake-work during the day and sleep during thenight)

Exclusion

Exclusion Criteria:

  • Having any other condition (including known drug or alcohol abuse, psychiatricdisorder including eating disorder) that precludes the subject from following andcompleting the protocol

  • Have been diagnosed, at any time, with type 1 diabetes mellitus (T1DM) or latentautoimmune diabetes in adults

  • Have hypoglycemia unawareness as judged by the investigator

  • Have had any episode of severe hypoglycemia (defined as requiring assistance due toneurologically disabling hypoglycemia) within the 6 months prior to screening

  • Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolarstate within the 6 months prior to screening

  • Have a known diagnosis of secondary diabetes (for example, diabetes caused byhemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy)

  • Excessive insulin resistance defined as having received a total daily dose ofinsulin >2.0 U/kg at the time of screening

  • Have a history of or are being evaluated for bariatric surgery including Roux-en-Ygastric bypass surgery, gastric banding, and/or gastric sleeve

  • Have cardiovascular disease, within the past 6 months prior to screening, defined asstroke, 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 orchronic hepatitis or cirrhosis), or elevated liver enzyme measurements

  • Have active or untreated malignancy, have been in remission from clinicallysignificant malignancy (other than basal cell or squamous cell skin cancer) for lessthan 5 years, or are at an increased risk for developing cancer or a recurrence ofcancer in the opinion of the investigator

  • Have had a blood transfusion or severe blood loss within 90 days prior to screeningor have known hemoglobinopathy, anemia, or any other traits known to interfere withmeasurement of HbA1

  • Have presence of clinically significant gastrointestinal disease (for example,clinically active gastroparesis associated with wide glucose fluctuations) in theinvestigator's opinion

  • Have used thiazolidinediones, glucagon-like peptide 1 receptor agonist, orpramlintide within 90 days prior to screening

Study Design

Total Participants: 112
Treatment Group(s): 2
Primary Treatment: Insulin Lispro-aabc
Phase: 4
Study Start date:
April 18, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Osmania Medical College & Hospital

    Hyderabad, Andhra Pradesh 500012
    India

    Active - Recruiting

  • King George Hospital, Visakhapatnam

    Visakhapatnam, Andhra Pradesh 530002
    India

    Site Not Available

  • King George Hospital, Visakhapatnam

    Vizag, Andhra Pradesh 530002
    India

    Site Not Available

  • Diabetes Research Centre

    Royapuram, Chennai India 600013
    India

    Site Not Available

  • Vijyaratna Dibetes Diagnosis Treatment Centre

    Ahmedabad, Gujrat 380007
    India

    Active - Recruiting

  • Center for Diabetes and Endocrine Care

    Bengaluru, Karnataka 560043
    India

    Site Not Available

  • Chellaram Diabetes Institute

    Pune, Maharashtra 411021
    India

    Active - Recruiting

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra 411004
    India

    Active - Recruiting

  • S. P. Medical College & A G Hospital

    Bikaner, Rajasthan 334003
    India

    Active - Recruiting

  • Rajasthan University of Health Sciences

    Jaipur, Rajasthan 302033
    India

    Site Not Available

  • Kovai Diabetes Speciality Center and Hospital

    Coimbatore, Tamil Nadu 641009
    India

    Active - Recruiting

  • Brij Medical Center Pvt. Ltd.

    Kanpur, Uttar Pradesh 208020
    India

    Active - Recruiting

  • Medical College & Hospital, Kolkata

    Kolkata, West Bengal 700073
    India

    Site Not Available

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