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Clinical Trial Summary

Several studies have reported that treatment with long-acting basal insulin degludec results in comparable improvement in glycated hemoglobin (HbA1c) levels and in lower rates of hypoglycemia compared to glargine U100 insulin in the outpatient setting. However, no previous studies have compared the safety and efficacy of the insulin degludec in the management of patients with type 2 diabetes in the hospital setting. Data regarding the efficacy and safety of degludec in the management of patients with type 2 diabetes in a hospital setting are scarce. Accordingly, the proposed study will provide novel and clinically useful information on the efficacy (blood glucose control) and safety (hypoglycemia) of degludec in the inpatient setting in patients with Type 2 Diabetes.


Clinical Trial Description

The purpose of this study is to find out if treatment with Degludec insulin when compared to glargine U-300 insulin will result in similar blood sugar control in patients with diabetes, who are admitted to a hospital. Primary outcome measures 1. Change in mean daily blood glucose concentration in hospitalized patients [ Time Frame: The first 7 days of therapy ] Blood glucose will be measured before each meal, bedtime and at 3:00 am. Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with basal bolus regimen or basal plus regimen with insulin degludec or glargine U-300 once daily plus aspart insulin before meals. Secondary outcome measures 1. Number of basic glucose readings between 70 mg/dl and 180 mg/dl before meals in hospitalized patients. Blood glucose will be measured before each meal, bedtime and at 3:00 am, and proportion of basic glucose readings between 70 mg/dl and 180 mg/dl will be recorded. 2. Number of hypoglycemic episodes (BG < 70 mg/dl and 54 mg/dl) in hospitalized patients. Blood glucose will be measured before each meal, bedtime and 3:00 am, and number of hypoglycemic episodes (< 70 mg/dl and 54 mg/dl) will be recorded. 3. Number of severe hypoglycemia (< 54 mg/dl) episodes in hospitalized patients Blood glucose will be measured before each meal, bedtime and at 3:00 am, and number of hypoglycemia (< 54 mg/dl) episodes will be recorded. 4. Number of episodes of severe hyperglycemia (BG > 240 mg/dl) in hospitalized patients Blood glucose will be measured before each meal, bedtime and at 3:00 am, and number of severe hyperglycemia (> 240 mg/dl) episodes will be recorded 5. Daily dose of basal insulin, daily dose of prandial insulin, and total daily dose in hospitalized patients The study team will document day and time of insulin administration of study drug given once daily and prandial- rapid-acting insulin (aspart) given before meals. The study team will also record dose and number of units given as supplement (correction) to correct hyperglycemia. Eligibility criteria Inclusion Criteria: 1. Males or females >18 years admitted to the hospital. 2. A known history of T2D treated either with diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy except for degludec and glargine U300. 3. Medical and surgical patients expected to be admitted length of stay (LOS) longer than 5 days 4. Subjects must have a randomization BG >140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate <18 mEq/L, pH < 7.30, or positive serum or urinary ketones). 5. Signed, informed consent prior to any study procedures Exclusion Criteria: 1. Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia). 2. Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c <7%. 3. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria. 4. Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, dulaglutide or albiglutide). 5. Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU. 6. Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day), or impaired renal function (eGFR< 30 ml/min), or congestive heart failure (NYHA- IV). 7. Patients with medical and surgical pancreatic disease. 8. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 9. Female subjects who are pregnant or breast feeding at time of enrolment into the study. 10. Known or suspected allergy to trial medication(s), excipients, or related products. Sample size calculation Noninferiority for the primary end point of glycemic control was defined as a mean blood glucose difference of <18 mg/dL between degludec and glargine U300. A blood glucose difference of such a magnitude has been reported in other superiority trials as nonclinically significant and is smaller than significant treatment effects. Assuming the true blood glucose difference between the treatment groups is zero, and using one-sided, two-sample t tests, we required 80 subjects for each treatment group to achieve 80% power. Accounting for a 10% attrition rate, we aimed to enrol 180 subjects in total to achieve >80% power. Interventions Experimental: Degludec inpatient Study participants treated with insulin prior to admission will receive 100% of the total daily dose (TDD) given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals. Degludec insulin 100 Units/mL, average dose: 30-40 U/day. Aspart (U-100) insulin 100 Units/mL, average dose: 20-40 U/day. Drug: Degludec Degludec is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner BG between 100 mg/dl and 180 mg/dl. Drug: Rapid-acting insulin Rapid-acting insulin will be given in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, aspart insulin dose will be held. Active Comparator: Glargine U300 inpatient Study participants treated with insulin prior to admission will receive 100% of the total daily dose (TDD) given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals. Glargine (U-300) insulin 100 Units/mL, average dose: 30-40 U/day. Rapid-acting (U-100) insulin 100 Units/mL, average dose: 20-40 U/day. Drug: Glargine (U-300) Glargine is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner BG between 100 mg/dl and 180 mg/dl. Drug: Rapid-acting insulin Aspart insulin will be given in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, aspart insulin dose will be held. Glucose monitoring Glucose levels will be assessed by capillary point-of-care (POC) testing before meals, bedtime and at 3:00 am. A subgroup of participants (n = 60) will be monitored with a professional (blinded) Abbott FreeStyle Libre continuous glucose monitoring (CGM). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05036876
Study type Interventional
Source Medanta, The Medicity, India
Contact Mr Surender, M.Sc
Phone 01244141414
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 1, 2021
Completion date March 15, 2022

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