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[No data.]


  
  
    
      
        
        
        
      
      
    
    
    
    
      
    
  
  
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  <description value="Meet either T1DM-specific eligibility criteria or T2DM-specific eligibility criteria
a. T1DM-specific criteria
..i. Diagnosis of T1DM based on the World Health Organization (WHO) diagnostic criteria
..ii. have been on the following daily insulin therapy for at least 1 year
...1) multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or
...2) continuous subcutaneous insulin infusion (CSII)
..iii. are between 18 and 64 years old at the time of informed consent
..iv. have a body mass index of 18.5 to 30.0 kg/m2 at the time of screening
b. T2DM-specific criteria
..i. Diagnosis of T2DM based on the World Health Organization (WHO) diagnostic criteria
..ii. have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year
...1) insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII
...2) OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine
..iii. are between 20 and 70 years old at the time of informed consent
..iv. have a body mass index of 18.5 to 35.0 kg/m2 at the time of screening"/>
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ii. have been on the following daily insulin therapy for at least 1 year
..1) multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or...2) continuous subcutaneous insulin infusion (CSII)
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..2) OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine
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