A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT06370715
- Lead Sponsor
- Eli Lilly and Company
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 112
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insulin Lispro-aabc + Insulin Glargine Insulin Glargine Participants will receive insulin lispro-aabc in combination with insulin glargine administered by subcutaneous (SC) injection. Insulin Lispro-aabc + Insulin Glargine Insulin Lispro-aabc Participants will receive insulin lispro-aabc in combination with insulin glargine administered by subcutaneous (SC) injection.
- Primary Outcome Measures
Name Time Method Percentage of Participants with at least 1 Episode of Hypoglycemia Baseline through Week 26 Percentage of participants with at least 1 episode of hypoglycemia will be reported.
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 26 in Body Weight Baseline, Week 26 Change from baseline to week 26 in body weight will be reported.
Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values Baseline, Week 26 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.
Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c) Baseline, Week 26 Change from baseline to week 26 in HbA1c will be reported.
Percentage of Participants Achieving HbA1c Less Than (<) 7% Week 26 Percentage of participants achieving HbA1c \<7% will be reported.
Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values Baseline, Week 26 1- and 2-hour PPG values are estimated from self-monitored blood glucose (SMBG)
Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score Baseline, Week 26 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.
Change from Baseline to Week 26 in Bolus Insulin Dose Baseline, Week 26 Change from Baseline to Week 26 in Bolus Insulin Dose will be reported.
Change from Baseline to Week 26 in Bolus Basal: Bolus Ratio Baseline, Week 26 Change from Baseline to Week 26 in Basal: Bolus Ratio will be reported.
Change from Baseline to Week 26 in Basal Insulin Dose Baseline, Week 26 Change from Baseline to Week 26 in Basal Insulin Dose will be reported.
Percentage of Participants with Severe Hypoglycemic Events Week 26 Percentage of participants with severe hypoglycemic events defined as (events/participants/year).
Percentage of Participants with Nocturnal Hypoglycemia Events Week 26 Percentage of participants with nocturnal hypoglycemia events defined as the incidence and rate (events/participant/year) of nocturnal hypoglycemia (BG\<54 mg/dL).
Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events Week 26 Percentage of participants with nocturnal and documented hypoglycemia events will be reported.
Trial Locations
- Locations (12)
Osmania Medical College & Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
King George Hospital, Visakhapatnam
🇮🇳Visakhapatnam, Andhra Pradesh, India
Diabetes Research Centre
🇮🇳Royapuram, Chennai India, India
Vijyaratna Dibetes Diagnosis Treatment Centre
🇮🇳Ahmedabad, Gujrat, India
Center for Diabetes and Endocrine Care
🇮🇳Bengaluru, Karnataka, India
Sahyadri Super Speciality Hospital
🇮🇳Pune, Maharashtra, India
Chellaram Diabetes Institute
🇮🇳Pune, Maharashtra, India
S. P. Medical College & A G Hospital
🇮🇳Bikaner, Rajasthan, India
Rajasthan University of Health Sciences
🇮🇳Jaipur, Rajasthan, India
Kovai Diabetes Speciality Center and Hospital
🇮🇳Coimbatore, Tamil Nadu, India
Brij Medical Center Pvt. Ltd.
🇮🇳Kanpur, Uttar Pradesh, India
Medical College & Hospital, Kolkata
🇮🇳Kolkata, West Bengal, India