Assessing a new insulin treatment for adults with Type 2 diabetes 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

This study is testing a new insulin treatment for adults with Type 2 diabetes in India to see if it works better and is safe compared to current options.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Eli Lilly and Company (industry)
• Locations: 12 sites (Hyderabad, Andhra Pradesh and 11 other locations)
• Trial ID: NCT06370715 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety of insulin lispro-aabc in adult participants diagnosed with Type 2 diabetes mellitus in India. Participants will undergo a 33-week process that includes a screening phase, a lead-in period, a treatment phase with insulin lispro-aabc, and a follow-up period. The study aims to determine how well this new insulin formulation works compared to existing treatments. Participants will be monitored for their blood sugar levels and overall health throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults with Type 2 diabetes for at least one year who are currently using multiple daily injection therapy.

Not a fit: Patients who have not been treated with insulin or those with Type 1 diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective insulin treatment option for adults with Type 2 diabetes.

How similar studies have performed: Other studies have shown promising results with similar insulin treatments, indicating potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Hyderabad, Andhra Pradesh and 11 other locations

• Osmania Medical College & Hospital — Hyderabad, Andhra Pradesh, India (RECRUITING)
• King George Hospital, Visakhapatnam — Visakhapatnam, Andhra Pradesh, India (NOT_YET_RECRUITING)
• Diabetes Research Centre — Royapuram, Chennai India, India (NOT_YET_RECRUITING)
• Vijyaratna Dibetes Diagnosis Treatment Centre — Ahmedabad, Gujrat, India (RECRUITING)
• Center for Diabetes and Endocrine Care — Bengaluru, Karnataka, India (NOT_YET_RECRUITING)
• Sahyadri Super Speciality Hospital — Pune, Maharashtra, India (RECRUITING)
• Chellaram Diabetes Institute — Pune, Maharashtra, India (RECRUITING)
• S. P. Medical College & A G Hospital — Bikaner, Rajasthan, India (RECRUITING)
• Rajasthan University of Health Sciences — Jaipur, Rajasthan, India (NOT_YET_RECRUITING)
• Kovai Diabetes Speciality Center and Hospital — Coimbatore, Tamil Nadu, India (RECRUITING)
• Brij Medical Center Pvt. Ltd. — Kanpur, Uttar Pradesh, India (RECRUITING)
• Medical College & Hospital, Kolkata — Kolkata, West Bengal, India (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Conditions: Diabetes Mellitus, Type 2, Diabetes mellitus, type 2 diabetes, Lyumjev, basaglar, Humalog