Phase
Condition
Diabetes And Hypertension
Diabetes Prevention
Diabetes Mellitus, Type 2
Treatment
Insulin Lispro-aabc
Insulin Glargine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 insulinglargin 300 U/mL, insulin determir, insulin degludec U-100, or neutralprotamine Hagedorn (NPH) insulin) in combination with at least 1 prandialinjection of bolus insulin (insulin lispro 100 U/mL or 200 U/mL, insulinaspart, 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 accordancewith local regulations. The dose of all OAMs must have been stable for ≥90 daysprior 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 ofinsulin therapy
Have a regular wake-sleep schedule (awake-work during the day and sleep during thenight)
Exclusion
Exclusion Criteria:
Having any other condition (including known drug or alcohol abuse, psychiatricdisorder including eating disorder) that precludes the subject from following andcompleting the protocol
Have been diagnosed, at any time, with type 1 diabetes mellitus (T1DM) or latentautoimmune diabetes in adults
Have hypoglycemia unawareness as judged by the investigator
Have had any episode of severe hypoglycemia (defined as requiring assistance due toneurologically disabling hypoglycemia) within the 6 months prior to screening
Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolarstate within the 6 months prior to screening
Have a known diagnosis of secondary diabetes (for example, diabetes caused byhemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy)
Excessive insulin resistance defined as having received a total daily dose ofinsulin >2.0 U/kg at the time of screening
Have a history of or are being evaluated for bariatric surgery including Roux-en-Ygastric bypass surgery, gastric banding, and/or gastric sleeve
Have cardiovascular disease, within the past 6 months prior to screening, defined asstroke, 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 orchronic hepatitis or cirrhosis), or elevated liver enzyme measurements
Have active or untreated malignancy, have been in remission from clinicallysignificant malignancy (other than basal cell or squamous cell skin cancer) for lessthan 5 years, or are at an increased risk for developing cancer or a recurrence ofcancer in the opinion of the investigator
Have had a blood transfusion or severe blood loss within 90 days prior to screeningor have known hemoglobinopathy, anemia, or any other traits known to interfere withmeasurement of HbA1
Have presence of clinically significant gastrointestinal disease (for example,clinically active gastroparesis associated with wide glucose fluctuations) in theinvestigator's opinion
Have used thiazolidinediones, glucagon-like peptide 1 receptor agonist, orpramlintide within 90 days prior to screening
Study Design
Connect with a study center
Osmania Medical College & Hospital
Hyderabad, Andhra Pradesh 500012
IndiaActive - Recruiting
King George Hospital, Visakhapatnam
Visakhapatnam, Andhra Pradesh 530002
IndiaSite Not Available
King George Hospital, Visakhapatnam
Vizag, Andhra Pradesh 530002
IndiaSite Not Available
Diabetes Research Centre
Royapuram, Chennai India 600013
IndiaSite Not Available
Vijyaratna Dibetes Diagnosis Treatment Centre
Ahmedabad, Gujrat 380007
IndiaActive - Recruiting
Center for Diabetes and Endocrine Care
Bengaluru, Karnataka 560043
IndiaSite Not Available
Chellaram Diabetes Institute
Pune, Maharashtra 411021
IndiaActive - Recruiting
Sahyadri Super Speciality Hospital
Pune, Maharashtra 411004
IndiaActive - Recruiting
S. P. Medical College & A G Hospital
Bikaner, Rajasthan 334003
IndiaActive - Recruiting
Rajasthan University of Health Sciences
Jaipur, Rajasthan 302033
IndiaSite Not Available
Kovai Diabetes Speciality Center and Hospital
Coimbatore, Tamil Nadu 641009
IndiaActive - Recruiting
Brij Medical Center Pvt. Ltd.
Kanpur, Uttar Pradesh 208020
IndiaActive - Recruiting
Medical College & Hospital, Kolkata
Kolkata, West Bengal 700073
IndiaSite Not Available
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