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

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Insulin glargine

NovoLog

Insulin Fiasp

Standard carbohydrate diet

About this trial

This is an interventional treatment trial for Type 2 Diabetes Treated With Insulin focused on measuring Fiasp, Novolog, Continuous glucose monitor (CGM), Hypoglycemia, Hyperglycemia, Hemoglobin A1c

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
1. Insulin
2. ≥ 2 oral/injectable agents
3. 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.

Sites / Locations

Boston Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1 insulin glargine and Novolog

Group 2 insulin glargine and Fiasp

Arm Description

Group 1 will receive daily basal insulin glargine with a scheduled bolus of meal insulin Novolog. Meal Novolog will be dosed at the time the subject starts to eat. If the premeal BG is ≥ 150 mg/dL, additional Novolog will be administered based off the correctional scale at the same time as the prandial insulin. The dose of Novolog will be administered by the floor nurse as per usual standard of care.

Group 2 will receive basal insulin glargine as dosed in Group 1. Meal insulin Fiasp dosing will be calculated the same way as Novolog dosing. If the premeal BG is ≥ 150 mg/dL, additional Fiasp will be administered based off the correctional scale at the same time as the prandial insulin.

Outcomes

Primary Outcome Measures

Postprandial glucose control

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

Secondary Outcome Measures

Glycemic control while hospitalized

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.

Percent of postprandial time in glycemic range of 70-140 mg/dL

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.

Percent of nocturnal time in glycemic target range 100-180 mg/dL

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

Percent of postprandial time spent with hypoglycemia

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

Percent of nocturnal time spent with hypoglycemia

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.

Percent of time spent with hypoglycemia during hospitalization

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.

Percent of postprandial time spent with level 1 hyperglycemia

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

Percent of postprandial time spent with level 2 hyperglycemia

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

Full Information

NCT ID

NCT04460326

First Posted

June 4, 2020

Last Updated

April 23, 2023

Sponsor

Boston Medical Center

Collaborators

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04460326

Brief Title

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

Acronym

In-FI

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 7, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Medical Center

Collaborators

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Treated With Insulin

Keywords

Fiasp, Novolog, Continuous glucose monitor (CGM), Hypoglycemia, Hyperglycemia, Hemoglobin A1c

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 insulin glargine and Novolog

Arm Type

Active Comparator

Arm Description

Arm Title

Group 2 insulin glargine and Fiasp

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Insulin glargine

Other Intervention Name(s)

Lantus®

Intervention Description

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%

Intervention Type

Drug

Intervention Name(s)

NovoLog

Other Intervention Name(s)

NovoLog®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Insulin Fiasp

Other Intervention Name(s)

Fiasp®

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard carbohydrate diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Postprandial glucose control

Description

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

Time Frame

4 hour postprandial

Secondary Outcome Measure Information:

Title

Glycemic control while hospitalized

Description

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.

Time Frame

From date of admission to date of discharge, up to 30 days

Title

Percent of postprandial time in glycemic range of 70-140 mg/dL

Description

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.

Time Frame

4 hour postprandial

Title

Percent of nocturnal time in glycemic target range 100-180 mg/dL

Description

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

Time Frame

From date of admission to date of discharge, up to 30 days

Title

Percent of postprandial time spent with hypoglycemia

Description

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

Time Frame

4 hours postprandial

Title

Percent of nocturnal time spent with hypoglycemia

Description

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.

Time Frame

From date of admission to date of discharge, up to 30 days

Title

Percent of time spent with hypoglycemia during hospitalization

Description

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.

Time Frame

From date of admission to date of discharge, up to 30 days

Title

Percent of postprandial time spent with level 1 hyperglycemia

Description

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

Time Frame

4 hours postprandial

Title

Percent of postprandial time spent with level 2 hyperglycemia

Description

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

Time Frame

4 hours postprandial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sara M Alexanian, MD

Phone

617-638-8545

sara.alexanian@bmc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Zhihui Ju, MPH

Phone

617-638-5921

zhihui.ju@bmc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sara M Alexanian, MD

Organizational Affiliation

Boston Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sara Alexanian, MD

Phone

617-638-8545

sara.alexanian@bmc.org

First Name & Middle Initial & Last Name & Degree

Sara Aleanian, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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