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

NCT06370715 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 18269I8B-MC-ITTA
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 12

Brief 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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus, type 2 diabetes, Lyumjev, basaglar, Humalog

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <54 Milligrams Per Deciliter (mg/dL)

  The percentage of participants with at least 1 documented hypoglycemic event was calculated as the number of participants with \>=1 documented hypoglycemic event divided by the total number of participants, multiplied by 100.

  Baseline through Week 26

• Rate of Documented Hypoglycemia With Blood Glucose <54 mg/dL

  Rate of documented hypoglycemia (events/participant/year) was calculated as the sum of documented hypoglycemic episodes divided by the cumulative days on treatment from all participants, multiplied by 365.

  Baseline through Week 26

Secondary Outcomes (15)

• Percentage of Participants With Severe Hypoglycemia

  Baseline through Week 26

• Percentage of Participants With at Least 1 Nocturnal Hypoglycemic Event With Blood Glucose <54 mg/dL

  Baseline through Week 26

• Rate of Nocturnal Hypoglycemia With Blood Glucose <54 mg/dL

  Baseline through Week 26

• Percentage of Participants With at Least 1 Nocturnal Hypoglycemic Event With Blood Glucose <70 mg/dL

  Baseline through Week 26

• Rate of Nocturnal Hypoglycemia With Blood Glucose <70 mg/dL

  Baseline through Week 26

Study Arms (1)

Insulin Lispro-aabc

EXPERIMENTAL

Participants received subcutaneous injections of insulin lispro-aabc 100 units/millilitre (U/mL) immediately (0 to 2 minutes) before each meal, in combination with once-daily insulin glargine 100 U/mL as basal insulin, during the 26-week treatment period.

Drug: Insulin Lispro-aabc; Drug: Insulin Glargine

Interventions

Insulin Lispro-aabc DRUG

Administered subcutaneously

Also known as: LY900014, Lyumjev

Insulin Lispro-aabc

Insulin Glargine DRUG

Administered subcutaneously

Also known as: Basaglar

Insulin Lispro-aabc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Cipla Ltd.: collaborator

Study Sites (12)

Osmania Medical College & Hospital

Hyderabad, Andhra Pradesh, 500012, India

Location

King George Hospital, Visakhapatnam

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Diabetes Research Centre

Royapuram, Chennai India, 600013, India

Location

Vijyaratna Dibetes Diagnosis Treatment Centre

Ahmedabad, Gujarat, 380007, India

Location

Center for Diabetes and Endocrine Care

Bengaluru, Karnataka, 560043, India

Location

Sahyadri Super Speciality Hospital

Pune, Maharashtra, 411004, India

Location

Chellaram Diabetes Institute

Pune, Maharashtra, 411021, India

Location

S. P. Medical College & A G Hospital

Bikaner, Rajasthan, 334003, India

Location

Rajasthan University of Health Sciences

Jaipur, Rajasthan, 302033, India

Location

Kovai Diabetes Speciality Center and Hospital

Coimbatore, Tamil Nadu, 641009, India

Location

Brij Medical Center Pvt. Ltd.

Kanpur, Uttar Pradesh, 208020, India

Location

Medical College & Hospital, Kolkata

Kolkata, West Bengal, 700073, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08004595979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 17, 2024
• Study Start: April 18, 2024
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: September 28, 2026
• Results First Posted: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

IN (12)