AT.LANTUS Study Summary
Primary Outcome The primary objective was to compare the two algorithms in terms of incidence of severe hypoglycemia, deļ¬ned according to criteria used in the Diabetes Control and Complications Trial (DCCT).
 
Secondary Outcomes Secondary objectives included baseline to end point change in glycemic con-
trol (HbA1c and FBG); incidence of symptomatic (symptoms of hypoglycemia responding to ingestion of carbohydrate or an episode associated with a blood glucose level less than 50 mg/dl [less than 2.8 mmol/l]), nocturnal (hypoglycemia occurring while the subject was asleep and associated with a blood glucose level less than 50 mg/dl [less than 2.8 mmol/l] but without symptoms), and asymptomatic hypoglycemia (associated with a blood glucose level less than 50 mg/dl [less than 2.8 mmol/l]); change in body weight; and insulin dose. 
 
Study Details Inclusion criteria Men or women>= 18 years, any oral or insulin therapy for >=6 months, BMI <40 kg/m2, A1C between 7.0 and 12.0%.
  Exclusion criteria impaired renal function (serum creatinine 2.0 mg/dl and current renal dialysis); acute or chronic metabolic acidosis; active liver disease or serum alanine aminotransferase or aspartate aminotransferase 2.5 times the upper limit of the normal range; history of hypoglycemia unawareness; diabetic retinopathy with surgery in the previous 3 months orplanned within 3 months after study entry; and pregnancy
Mean age 57.5 +/-10 years
gender F/M 50/50
Mean Duration of diabetes 12.3+/-7 years
Prior use of insulin Yes
Comorbidities Non given
Prior therapies all insulin types and oral agents
Use of non-insulin therapies during study Yes, at the investigator's discretion
Study duration 24 weeks
Plateau for fasting plasma glucose 24 weeks
Ending insulin dose 45 units
  Hypoglycemia rates overall 33.3%, symptomatic 29.7%, asymptomatic 10.3%, nocturnal 4.1%, 
  Subjects with severe hypoglycemia 1.1%; 2.36 events per 100 patient-years
     
Titration Protocol Used in Study  Starting dose of insulin highest fasting glucose value in mmol/L over the previous 7 days
  Titration interval every 3 days
Titration increment if above target +0 to 2 units for BG >=100 mg/dL and <120 mg/dL at the discretion of the investigator; +2 units for BG >=120 mg/dL
Titration target fasting BG <=100 mg/dL