Safety of Lyumjev in Adult Patients with Diabetes in India

Phase 4

Conditions: Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Registration Number: CTRI/2023/12/060953

Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Subjects diagnosed (clinically) with T2DM for =1 year prior to screening.

2. Treated for =90 days prior to screening with MDI therapy

a. On basal insulin (insulin glargine 100 U/mL [Basaglar or Lantus] or insulin glargine 300 U/mL, insulin detemir, insulin degludec U-100, or 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, Fiasp® fast-acting insulin aspart), OR

b. premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily except for IDegAsp injected once daily

3. May have been treated with up to 3 OAMs including metformin, sodium-glucose cotransporter (SGLT)-2 inhibitor, dipeptidyl peptidase (DPP)-4 inhibitor, sulfonylurea, meglitinide, or alpha glucosidase inhibitor in accordance with local regulations. The dose of all OAMs must have been stable for =90 days prior to screening

4. Have an HbA1c value =7.5% and =10% according to the central laboratory at screening

5. Body mass index =45.0 kg/m2

Exclusion Criteria

1. 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

2. Have been diagnosed, at any time, with T1DM or latent autoimmune diabetes in adults

3. Have hypoglycemia unawareness as judged by the investigator

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

5. Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening

6. Have a known diagnosis of secondary diabetes (for example, diabetes caused by hemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy)

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

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

9. 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

10. Renal:

a. History of renal transplantation

b. Currently receiving renal dialysis

c. Serum creatinine >2.0 mg/dL (177 µmol/L) at screening

11. Hepatic: Have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis or cirrhosis), or elevated liver enzyme measurements as indicated below at screening:

a. Total bilirubin level (TBL) =2X the upper limit of normal (ULN [with the exception of Gilbert’s disease]) as defined by the central laboratory, or

b. Alanine aminotransferase (ALT) =3X ULN as defined by the central laboratory, or

c. Aspartate aminotransferase (AST) =3X ULN as defined by the central laboratory.

12. Malignancy: 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

13. Having any hypersensitivity or allergy to any of the insulins or excipients used in this trial

14. Hematologic: 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 HbA1c

15. Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations) in the investigator’s opinion

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence (percentage of subjects with at least 1 event) and rate (events/subject/year) of all documented hypoglycemia (BG <54 mg/dL)Timepoint: From baseline through Week 26

Secondary Outcome Measures

Name	Time	Method
1. SAEs and TEAEs <br/ ><br>2. Incidence and rate (events/subject/year) of severe hypoglycemic events <br/ ><br>3. Incidence and rate (events/subject/year) of nocturnal hypoglycemia (BG <54 mg/dL) <br/ ><br>4. Incidence and rate (events/subject/year) of nocturnal and all documented hypoglycemic events (BG <70 mg/dL) <br/ ><br>5. Change in body weight <br/ ><br>6. Change in ITSQ scoresTimepoint: 1. From baseline through study followup <br/ ><br>2. From baseline through Week 26 <br/ ><br>3. From baseline through Week 26 <br/ ><br>4. From baseline through Week 26 <br/ ><br>5. From baseline to Week 26 <br/ ><br>6. From baseline to Week 26