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
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | Cipla Ltd. |
India,
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 |
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