Clinical trial NCT06370715: A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus, type 2 diabetes, Lyumjev, basaglar, Humalog
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Cipla Ltd.
First posted: 2024-04-17
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of Participants with at least 1 Episode of Hypoglycemia
timeFrame: Baseline through Week 26
Secondary outcomes:
measure: Percentage of Participants with Severe Hypoglycemic Events
timeFrame: Week 26
measure: Percentage of Participants with Nocturnal Hypoglycemia Events
timeFrame: Week 26
measure: Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events
timeFrame: Week 26
measure: Change from Baseline to Week 26 in Body Weight
timeFrame: Baseline, Week 26
measure: Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
timeFrame: Baseline, Week 26
measure: Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 26
measure: Percentage of Participants Achieving HbA1c Less Than (<) 7%
timeFrame: Week 26
measure: Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values
timeFrame: Baseline, Week 26
measure: Change from Baseline to Week 26 in Bolus Insulin Dose
timeFrame: Baseline, Week 26
measure: Change from Baseline to Week 26 in Basal Insulin Dose
timeFrame: Baseline, Week 26
measure: Change from Baseline to Week 26 in Bolus Basal: Bolus Ratio
timeFrame: Baseline, Week 26
measure: Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Osmania Medical College & Hospital
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital, Visakhapatnam
state: Andhra Pradesh
city: Royapuram
country: India
facility: Diabetes Research Centre
state: Chennai India
city: Ahmedabad
country: India
facility: Vijyaratna Dibetes Diagnosis Treatment Centre
state: Gujrat
city: Bengaluru
country: India
facility: Center for Diabetes and Endocrine Care
state: Karnataka
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Chellaram Diabetes Institute
state: Maharashtra
city: Bikaner
country: India
facility: S. P. Medical College & A G Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Rajasthan University of Health Sciences
state: Rajasthan
city: Coimbatore
country: India
facility: Kovai Diabetes Speciality Center and Hospital
state: Tamil Nadu
city: Kanpur
country: India
facility: Brij Medical Center Pvt. Ltd.
state: Uttar Pradesh
city: Kolkata
country: India
facility: Medical College & Hospital, Kolkata
state: West Bengal
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: