Type 2 Diabetes Clinical Trial
Official title:
Insulin Degludec Versus Glargine U300 for the Management of Hospitalized Patients With Type 2 Diabetes: Randomized Controlled Trial
NCT number | NCT05036876 |
Other study ID # | MMDHS01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 10, 2021 |
Est. completion date | March 1, 2022 |
Verified date | October 2023 |
Source | Medanta, The Medicity, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Limited data exist about the use of insulin degludec and insulin glargine U300 in the hospitalized patients. A previous study compared the safety and efficacy of insulin degludec versus insulin glargine U100 for the management of hospitalized patients with type 2 diabetes. However, there is no data comparing the efficacy and safety of insulin degludec versus insulin glargine U300 for the management of hospitalized patients with type 2 diabetes. Accordingly, the proposed study will provide a clinically useful information on the efficacy (blood glucose control) and safety (hypoglycemia) of insulin degludec versus insulin glargine U300 for the management of hospitalized patients with type 2 diabetes.
Status | Completed |
Enrollment | 220 |
Est. completion date | March 1, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: 1. Males or females 30 years or above admitted to the hospital for elective CABG surgery 2. A known history of type 2 diabetes treated with any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy except for degludec and glargine U300. 3. Study participants must have a randomization total daily dose (TDD) insulin requirement of at least 20 units per day. 4. 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, or dulaglutide). 5. 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). 6. Patients with medical and surgical pancreatic disease. 7. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 8. Known or suspected allergy to trial medication(s), excipients, or related products. |
Country | Name | City | State |
---|---|---|---|
India | Division Of Endocrinology and Diabetes , Medanta The Medicity Hospital | Gurgaon | Haryana |
Lead Sponsor | Collaborator |
---|---|
Medanta, The Medicity, India |
India,
Pasquel FJ, Gianchandani R, Rubin DJ, Dungan KM, Anzola I, Gomez PC, Peng L, Hodish I, Bodnar T, Wesorick D, Balakrishnan V, Osei K, Umpierrez GE. Efficacy of sitagliptin for the hospital management of general medicine and surgery patients with type 2 dia — View Citation
Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, Munoz C, Newton C, Peng L, Baldwin D. Comparison of inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients with type 2 diabetes — View Citation
Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for t — View Citation
Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 sur — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mean daily blood glucose concentration in hospitalized patients | 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. | The first 7 days of therapy | |
Secondary | 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. | The first 7 days of therapy | |
Secondary | 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 | The first 7 days of therapy | |
Secondary | 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 | The first 7 days of therapy | |
Secondary | 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 | The first 7 days of therapy | |
Secondary | 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 | The first 7 days of therapy | |
Secondary | Average blood glucose (mg/dL), percentage time in target, percentage time below target, and percentage time above target in a subgroup of study participants. | A subgroup of participants (n = 100) will be monitored using continuous glucose monitoring system (CGMS) (FreeStyle Libre). | The first 7 days of therapy |
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