Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes mellitus, type 2 diabetes, Lyumjev, basaglar, Humalog
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).
Interventions
DRUGInsulin Lispro-aabc
Administered SC
DRUGInsulin Glargine
Administered SC
Sponsors
Cipla Ltd.
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 Hemoglobin A1c (HbA1c) | Baseline, Week 26 | Change from baseline to week 26 in HbA1c will be reported. |
| Percentage of Participants with Severe Hypoglycemic Events | Week 26 | Percentage of participants with severe hypoglycemic events defined as (events/participants/year). |
| 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 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 Basal Insulin Dose | Baseline, Week 26 | Change from Baseline to Week 26 in Basal 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 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. |
| Percentage of Participants Achieving HbA1c Less Than (<) 7% | Week 26 | Percentage of participants achieving HbA1c \<7% will be reported. |
Countries
India
Outcome results
None listed