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

A 26- Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess The Safety of Lyumjev in Adult Patients With Type 2 Diabetes Mellitus in India

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Insulin Lispro-aabc

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500012
      • Osmania Medical College & Hospital
    • Visakhapatnam, Andhra Pradesh, India, 530002
      • King George Hospital, Visakhapatnam
  • Chennai India
    • Royapuram, Chennai India, India, 600013
      • Diabetes Research Centre
  • Gujarat
    • Ahmedabad, Gujarat, India, 380007
      • Vijyaratna Dibetes Diagnosis Treatment Centre
  • Karnataka
    • Bengaluru, Karnataka, India, 560043
      • Center for Diabetes and Endocrine Care
  • Maharashtra
    • Pune, Maharashtra, India, 411004
      • Sahyadri Super Speciality Hospital
    • Pune, Maharashtra, India, 411021
      • Chellaram Diabetes Institute
  • Rajasthan
    • Bikaner, Rajasthan, India, 334003
      • S. P. Medical College & A G Hospital
    • Jaipur, Rajasthan, India, 302033
      • Rajasthan University of Health Sciences
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India, 641009
      • Kovai Diabetes Speciality Center and Hospital
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208020
      • Brij Medical Center Pvt. Ltd.
  • West Bengal
    • Kolkata, West Bengal, India, 700073
      • Medical College & Hospital, Kolkata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin Lispro-aabc + Insulin Glargine; Participants will receive insulin lispro-aabc in combination with insulin glargine administered by subcutaneous (SC) injection.	Drug: Insulin Glargine; Administered SC; Drug: Insulin Lispro-aabc; Administered SC; Other Names: LY900014

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with at least 1 Episode of Hypoglycemia	Percentage of participants with at least 1 episode of hypoglycemia will be reported.	Baseline through Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Severe Hypoglycemic Events	Percentage of participants with severe hypoglycemic events defined as (events/participants/year).	Week 26
Percentage of Participants with Nocturnal Hypoglycemia Events	Percentage of participants with nocturnal hypoglycemia events defined as the incidence and rate (events/participant/year) of nocturnal hypoglycemia (BG<54 mg/dL).	Week 26
Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events	Percentage of participants with nocturnal and documented hypoglycemia events will be reported.	Week 26
Change from Baseline to Week 26 in Body Weight	Change from baseline to week 26 in body weight will be reported.	Baseline, Week 26
Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score	The ITSQ is a 22-item, participant-completed questionnaire that assesses insulin treatment satisfaction over the past 4 weeks for participants with diabetes in 5 domains: Inconvenience of Regimen (5 items), Lifestyle Flexibility (3 items), Glycemic Control (3 items), Hypoglycemic Control (5 items), Insulin Delivery Device Satisfaction (6 items). Participants respond to each item on a 7-point Likert scale ranging from "not at all" to "extremely." Scores can be generated for each domain and the overall score is transformed to a scale of 0-100. Higher scores indicate better treatment satisfaction.	Baseline, Week 26
Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c)	Change from baseline to week 26 in HbA1c will be reported.	Baseline, Week 26
Percentage of Participants Achieving HbA1c Less Than (<) 7%	Percentage of participants achieving HbA1c <7% will be reported.	Week 26
Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values	1- and 2-hour PPG values are estimated from self-monitored blood glucose (SMBG)	Baseline, Week 26
Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values	SMBG measurements were taken at 9 time points: fasting, 1 hour post breakfast, 2 hours post breakfast, pre lunch,1 hour post lunch, 2 hours post lunch, pre dinner, 1 hour post dinner, and 2 hours post dinner.	Baseline, Week 26
Change from Baseline to Week 26 in Bolus Insulin Dose	Change from Baseline to Week 26 in Bolus Insulin Dose will be reported.	Baseline, Week 26
Change from Baseline to Week 26 in Basal Insulin Dose	Change from Baseline to Week 26 in Basal Insulin Dose will be reported.	Baseline, Week 26
Change from Baseline to Week 26 in Bolus Basal: Bolus Ratio	Change from Baseline to Week 26 in Basal: Bolus Ratio will be reported.	Baseline, Week 26

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Cipla Ltd.
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Actual): September 2, 2025
• Study Completion (Actual): September 2, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes mellitus, type 2 diabetes, Lyumjev, basaglar, Humalog
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Insulin Glargine
• Other Study ID Numbers: 18269; I8B-MC-ITTA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes