Type 2 Diabetes Treated With InsulinPhase 3In-FINCT04460326
Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing Insulin glargine, NovoLog and Insulin Fiasp in people with Type 2 Diabetes Treated With Insulin, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- Insulin glargine, NovoLog and Insulin Fiasp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to 27 May 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- Insulin glargine, NovoLog, Insulin Fiasp, Standard carbohydrate diet
- Keywords
- Fiasp, Novolog, Continuous glucose monitor (CGM), Hypoglycemia, Hyperglycemia, Hemoglobin A1c
- Medical subject headings
- Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
Also called Lantus®
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%
NovoLogDrug
Also called NovoLog®
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.
Insulin FiaspDrug
Also called Fiasp®
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.
Standard carbohydrate dietOther
Standard carbohydrate diet as per usual hospital care (75g with each meal)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 insulin glargine and Novolog | Active comparator | 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 blood glucose (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. Receives: Drug: Insulin glargine; Drug: NovoLog; Other: Standard carbohydrate diet |
| Group 2 insulin glargine and Fiasp | Experimental | 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. Receives: Drug: Insulin glargine; Drug: Insulin Fiasp; Other: Standard carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glucose Control
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.
Measured: 3 days
Secondary outcomes (8)
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.
Measured: 3 days
Percent of Time Spent 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.
Measured: 3 days
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.
Measured: 3 days
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
Measured: 3 days
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.
Measured: 3 days
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.
Measured: 4 hours postprandial
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.
Measured: 4 hours postprandial
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.
Measured: 4 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start7 Dec 2020
- Primary completion27 May 2023
- Study completion27 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Sara M Alexanian, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460326
- Sponsor's protocol ID
- H-39600
- Acronym
- In-FI
- Status last verified
- Feb 2024
- First submitted
- 4 Jun 2020
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexanian SM, Cheney MC, Bello Ramos JC, Spartano NL, Wolpert HA, Steenkamp DW. Impact of Meal Insulin Bolus Timing and Bedtime Snacking on Continuous Glucose Monitoring-Derived Glycemic Metrics in Hospitalized Inpatients. Diabetes Technol Ther. 2025 Jul;27(7):511-516. doi: 10.1089/dia.2025.0027. Epub 2025 Mar 11.
PubMed 40067436
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04460326
- Acronym / sponsor ID
- In-FI / H-39600
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- Fiasp, Novolog, Continuous glucose monitor (CGM), Hypoglycemia, Hyperglycemia, Hemoglobin A1c
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 27 May 2023 (actual)
- Study completion
- 27 May 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 insulin glargine and Novolog | Active comparator | Drug: Insulin glargine, Drug: NovoLog, Other: Standard carbohydrate dietGroup 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 blood glucose (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 insulin glargine and Fiasp | Experimental | Drug: Insulin glargine, Drug: Insulin Fiasp, Other: Standard carbohydrate dietGroup 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin glargineAlso: Lantus®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% | Drug | Group 1 insulin glargine and Novolog, Group 2 insulin glargine and Fiasp |
| NovoLogAlso: NovoLog®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. | Drug | Group 1 insulin glargine and Novolog |
| Insulin FiaspAlso: Fiasp®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. | Drug | Group 2 insulin glargine and Fiasp |
| Standard carbohydrate dietStandard carbohydrate diet as per usual hospital care (75g with each meal) | Other | Group 1 insulin glargine and Novolog, Group 2 insulin glargine and Fiasp |
Primary outcome
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.
8 secondary outcomes
Glycemic Control While Hospitalized
Time frame: 3 days
Percent of Time Spent in Glycemic Range of 70-140 mg/dL
Time frame: 3 days
Percent of Time Spent With Hypoglycemia During Hospitalization
Time frame: 3 days
Percent of Nocturnal Time in Glycemic Target Range 100-180 mg/dL
Time frame: 3 days
Percent of Nocturnal Time Spent With Hypoglycemia
Time frame: 3 days
Percent of Postprandial Time Spent With Level 1 Hyperglycemia
Time frame: 4 hours postprandial
Percent of Postprandial Time Spent With Level 2 Hyperglycemia
Time frame: 4 hours postprandial
Percent of Postprandial Time Spent With Hypoglycemia
Time frame: 4 hours postprandial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40067436Alexanian SM, Cheney MC, Bello Ramos JC, Spartano NL, Wolpert HA, Steenkamp DW. Impact of Meal Insulin Bolus Timing and Bedtime Snacking on Continuous Glucose Monitoring-Derived Glycemic Metrics in Hospitalized Inpatients. Diabetes Technol Ther. 2025 Jul;27(7):511-516. doi: 10.1089/dia.2025.0027. Epub 2025 Mar 11.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Treated With Insulin
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Not yet recruiting
Transitioning Recently Admitted Patients With Non-Insulin and Insulin-treated Type 2 Diabetes to Innovative Glucose Monitoring
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara M Alexanian, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin glargine, NovoLog and Insulin Fiasp in people with Type 2 Diabetes Treated With Insulin, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Glucose Control (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.