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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06370715
• Other study ID #: 18269
• Secondary ID: I8B-MC-ITTA
• Status: Recruiting
• Phase: Phase 4
• Start date: April 18, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Lispro-aabc
Administered SC
• Insulin Glargine
Administered SC

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Cipla Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants with Severe Hypoglycemic Events	Percentage of participants with severe hypoglycemic events defined as (events/participants/year).	Week 26
Secondary	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
Secondary	Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events	Percentage of participants with nocturnal and documented hypoglycemia events will be reported.	Week 26
Secondary	Change from Baseline to Week 26 in Body Weight	Change from baseline to week 26 in body weight will be reported.	Baseline, Week 26
Secondary	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
Secondary	Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c)	Change from baseline to week 26 in HbA1c will be reported.	Baseline, Week 26
Secondary	Percentage of Participants Achieving HbA1c Less Than (<) 7%	Percentage of participants achieving HbA1c <7% will be reported.	Week 26
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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