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NCT Number: NCT04460326

Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus

Hyperglycemia affects 30-40% of hospitalized patients. Despite the fact that basal/bolus insulin therapy has been demonstrated to improve glycemic control and clinical outcomes in patients, achieving good glucose control remains a challenge.

This study examines the effects of Fiasp (a faster acting insulin) on blood sugars after meals compared to another type of insulin known as Novolog. The study will be performed in patients with type 2 diabetes admitted to the hospital, who are not in the intensive care unit, and who are being seen by the inpatient diabetes consult team. Eligible participants will be treated with Fiasp or Novolog injected multiple times a day before meals and at bedtime, in addition to a once daily injection of insulin glargine as basal insulin. Which type of meal time insulin (Fiasp vs Novolog) the subject gets is decided by chance, like the flip of a coin. Insulin doses will be started and titrated based on a protocol. All the subjects will wear a blinded continuous glucose monitoring (CGM)) sensor placed in their arm which they will wear for 72 hours during the study. The glucose values from the CGM, collected during the time it is worn, will be downloaded and compared to assess the response to the two different types of insulins - Fiasp and Novolog. The goal is to determine if Fiasp works as well as or better than Novolog in controlling blood sugars, particularly after meals, in the subjects of the study.

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Key information

Conditions

Type 2 Diabetes Treated With Insulin Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-speaking
  • Males and female adult subjects admitted to Boston Medical Center to a medical or surgical floor.
  • Consultation by the Inpatient Diabetes Service at Boston Medical Center is required prior to consent.
  • Age ≥ 21 and <= 80 years.
  • Diagnosed with type 2 diabetes at least 180 days prior to screening.
  • Hyperglycemia during admission, as defined by a point of care and/or venous blood glucose ≥ 140 mg/dL.
  • Prior to admission subjects must be using one of the following for outpatient diabetes management:
  • Insulin
  • ≥ 2 oral/injectable agents
  • One oral/injectable agent with a hemoglobin A1c of ≥ 8% within 3 months of enrollment.
  • Patients who are expected to remain hospitalized for a minimum of 48 hours following CGM sensor placement.
  • BMI <45 kg/m^2.
  • Subjects must have insulin glargine dosing planned at bedtime for the duration of the study period. Morning and afternoon dosing of insulin glargine are exclusionary.

Exclusion criteria

  • Patients with a history of type 1 diabetes or late-onset autoimmune diabetes (LADA).
  • Treatment or plan for treatment with glucocorticoids during the index hospitalization.
  • Female patients who are pregnant (tested during hospitalization or screening) or breast-feeding during the hospitalization.
  • Patients admitted with the following conditions: diabetic ketoacidosis, hyperosmolar hyperglycemic state, solid organ transplantation, or coronary artery bypass surgery.
  • Prior diagnosis of gastroparesis or cirrhosis.
  • Acute or chronic kidney disease with a serum creatinine of ≥ 2 mg/dL at the time of screening.
  • Clinically significant nausea and/or vomiting or unable to consume more than 30 grams of carbohydrate at each meal.
  • Patients expected to receive nothing by mouth (NPO) for >24 hours.
  • Use of continuous or intermittent enteral feeding or parenteral nutrition.
  • Patient receiving aspirin and/or vitamin C during the hospitalization.
  • Any mental condition rendering the subject unable to provide informed consent.
  • Patients currently incarcerated.
  • Patients using >1 unit/kg/day of insulin prior to admission.
  • Insulin pump usage within the 2 weeks prior to or during admission.
  • Patients currently using real-time continuous glucose monitoring (CGM) or personal flash glucose monitoring system (FGM).
  • Patients with a history of an allergy to any of the types of insulin or one of the excipients in the insulin used in the study.

Treatment and study plan

insulin glargine

Drug

Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in >10%

Other names: Lantus®

NovoLog

Drug

Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.

Other names: NovoLog®

Insulin Fiasp

Drug

Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.

Other names: Fiasp®

standard carbohydrate diet

Other

Standard carbohydrate diet as per usual hospital care (75g with each meal)

Primary outcomes

  1. Postprandial Glucose Control

    Time frame: 3 days

    Percent of time spent in the glycemic target range of 100-180 mg/dL in the 4 hour postprandial period will be assessed using a continuous glucose monitoring (CGM) system.

Secondary outcomes

  1. Glycemic Control While Hospitalized

    Time frame: 3 days

    Percent of time spent in the glycemic target range of 100-180 mg/dL during the duration of the study will be assessed using a continuous glucose monitoring (CGM) system.

  2. Percent of Time Spent in Glycemic Range of 70-140 mg/dL

    Time frame: 3 days

    Percent of time spent in the glycemic target range of 70-140 mg/dL during the duration of the study assessed using a continuous glucose monitoring (CGM) system.

  3. Percent of Time Spent With Hypoglycemia During Hospitalization

    Time frame: 3 days

    The percent of time in three categories of hypoglycemia : <70 mg/dL, <54 mg/dL, and <40 mg/dL will be assessed using a CGM during hospitalization.

  4. Percent of Nocturnal Time in Glycemic Target Range 100-180 mg/dL

    Time frame: 3 days

    The percent of nocturnal time (from 00.01 AM to 5:59 AM) in the glycemic target range of 100-180 mg/dL

  5. Percent of Nocturnal Time Spent With Hypoglycemia

    Time frame: 3 days

    The percent of nocturnal time (from 00.01 AM to 5:59 AM) in three categories of hypoglycemia: <70 mg/dL, <54 mg/dL, and <40 mg/dL will be assessed using CGM.

  6. Percent of Postprandial Time Spent With Level 1 Hyperglycemia

    Time frame: 4 hours postprandial

    The percent of time spent in level 1 hyperglycemia (181-239 mg/dL) will be assessed using CGM in the 4 hour postprandial period.

  7. Percent of Postprandial Time Spent With Level 2 Hyperglycemia

    Time frame: 4 hours postprandial

    The percent of time spent in level 2 hyperglycemia (>240 mg/dL) will be assessed using CGM in the 4 hour postprandial period.

  8. Percent of Postprandial Time Spent With Hypoglycemia

    Time frame: 4 hours postprandial

    The percent of postprandial time in three categories of hypoglycemia will be assessed: <70 mg/dL, <54 mg/dL, and <40 mg/dL.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

Comparison of Postprandial Glycemic Control in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus Using Novolog vs. Fiasp Insulin: a Randomized Controlled Open Label Trial

Acronym: In-FI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2020
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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