Oral Anti Diabetic Agents in the Hospital

Emory University

Status and phase: Enrolling; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Supplemental insulin; Device: Continuous glucose monitoring (CGM); Drug: Oral Anti-diabetes Drugs alone; Drug: Basal bolus insulin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04416269

1K23DK124647-01 (U.S. NIH Grant/Contract)

IRB00117027

Details and patient eligibility

About

This randomized controlled clinical trial will assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in the hospital. The primary outcome of the study is to determine differences in glycemic control as measured by mean daily blood glucose concentration between oral antidiabetic medications and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).

Full description

Hyperglycemia in the hospital is common and has been associated with increased hospital complications, length of stay, and mortality. Improving glycemic control has been shown to improve length of stay, multi-organ failure, systemic infections, as well as short- and long-term mortality. Clinical guidelines from professional organizations recommend the use of subcutaneous (SQ) insulin as the preferred therapy for glycemic control in general medical and surgical patients with T2D. This approach, however, is labor intensive requiring multiple daily insulin injections, costly, and associated with significant risk of iatrogenic hypoglycemia

Over 75% of patients with T2D are treated with oral antidiabetic drugs (OADs) but due to the lack of safety and efficacy data from randomized controlled trials, clinical guidelines recommend stopping OADs during hospitalization. The current clinical guidelines have raised concerns with the use of OADs including risk of hypoglycemia with sulfonylureas, fluid retention and worsening of heart failure with thiazolidinediones, and risk of metformin-associated lactic acidosis in patients with severe renal impairment. However, several observational studies have reported that the use of OADs results in similar glycemic control without increased risk of complications compared to insulin regimens. A recent observational study that included 17,325 hospitalized patients with T2D, found that patients treated with OADs had similar glycemic control without differences in complications and no increase in rates of hypoglycemia compared to those treated with insulin.

This study will assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in hospital patients with T2D. For a subset of participants (50 patients per group), a CGM devise will be placed for the duration of the study to assess parameters of glycemic control and hypoglycemia.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females, age 18-80 years admitted to a general medicine and surgery services
• Known history of T2D receiving OADs either as monotherapy or in combination therapy
• Admission BG < 250 mg/dl or randomization BG <250 mg/dl and not receiving basal insulin
• Patients receiving OADs in combination with GLP-1 receptor agonists (GLP-1RA) who have HbA1c <7.5% within the past three months
• HbA1c <10%

Exclusion criteria

• No known history of diabetes
• Laboratory evidence of diabetic ketoacidosis
• Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis, or ketonuria)
• Meeting any exclusion criteria based on specific contraindications to their home oral therapy
• Acute critical illness or cardiac surgery expected to require admission to a critical care unit
• Gastrointestinal obstruction, adynamic ileus, or expected to require gastrointestinal suction
• Medical or surgical patients expected to be kept NPO for >24-48 hours after admission or after completion of surgical procedure
• Impaired renal function (eGFR <30 ml/min)
• Current treatment with oral or injectable corticosteroid
• Mental condition rendering the subject unable to understand the nature and scope of the study
• Female subjects who are pregnant or breastfeeding at time of enrollment in the study
• New or recent onset (within two weeks) of coronavirus disease 2019 (COVID-19) infection at the time of admission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Oral Anti-diabetes Drugs (OADs) alone

Experimental group

Description:

OADs will be continued at same outpatient dosage unless contraindicated

Treatment:

Drug: Oral Anti-diabetes Drugs alone

Device: Continuous glucose monitoring (CGM)

Drug: Supplemental insulin

Basal bolus insulin

Active Comparator group

Description:

Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) will be used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication will be discontinued on admission.

Treatment:

Drug: Basal bolus insulin

Device: Continuous glucose monitoring (CGM)

Drug: Supplemental insulin