Type 2 DiabetesPhase 4NCT03013985

Glargine U300 Hospital Trial

A Phase 4 study testing Glargine U300, Glargine U100 and Glulisine Insulin in people with Type 2 Diabetes, run by Emory University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Glargine U300, Glargine U100 and Glulisine Insulin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: 4 sitesUnited States
Study dates: 17 May 2017to 22 Mar 2019
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females between > 18 years admitted to a general medicine or surgical service.
Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the exception of degludec and glargine U300.
Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).

Who cannot join

Subjects with increased BG concentration, but without a known history of diabetes.
Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, dulaglutide or albiglutide).
Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30 ml/min).
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Female subjects who are pregnant or breast feeding at time of enrollment into the study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University
Atlanta, Georgia, 30322
Cleveland Clinic
Cleveland, Ohio, 44195
Hennepin County Medical Center
Minneapolis, Minnesota, 55415

Other trials in United States

About this study

Official title: A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients With Type 2 Diabetes

Read the detailed description

Several randomized clinical trials done previously in medicine and surgical patients with T2D have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose (BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in lower rate of hospital complications. Glargine U300 results in similar improvement but in lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however, have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and diabetes in the hospital setting. This study will determine if treatment with glargine U300 has a similar glucose control in patients with diabetes admitted to the hospital and if glargine U300 will result in lower number of low blood sugars compared to glargine U100 .

Conditions: Type 2 Diabetes
Being tested: Glargine U300, Glargine U100, Glulisine Insulin
Keywords: Blood glucose
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Glargine U300Drug
Also called Toujeo
Glargine U300 is a new generation long-acting insulin.
Glargine U100Drug
Also called Lantus
Glargine U100 is a long-acting insulin.
Glulisine InsulinDrug
Also called Apidra
Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.

Study groups in NCT03013985
Study group	Role	What they receive
Basal bolus insulin with glargine U300 and glulisine insulin	Experimental	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Receives: Drug: Glargine U300; Drug: Glulisine Insulin
Basal bolus insulin with glargine U100 and glulisine insulin	Active comparator	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Receives: Drug: Glargine U100; Drug: Glulisine Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Daily Blood Glucose Concentration Inpatient
The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.
Measured: up to 10 days (day of hospital discharge)
Mean Daily Blood Glucose Concentration After Hospital Discharge
Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.
Measured: assessed from day 11 (day after hospital discharge) up to 3 months

Secondary outcomes (12)

Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%
Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated.
Measured: up to 3 months post enrollment
Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%
Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded
Measured: up to 3 months post enrollment
Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days
Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days
Measured: Up to 3 days
Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days
Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days
Measured: Up to 5 days
Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days
Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated.
Measured: Up to 10 days
Percent of Blood Glucose 70-180 Measured by Point of Care Test
Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test
Measured: 3 months post enrollment
Percent of Subjects With Hypoglycemic Events
Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded.
Measured: 3 months post enrollment
Percent of Subjects With Severe Hypoglycemia
Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded.
Measured: 3 months post enrollment
Number of Days of Hospital Stay
The number of days of hospital stay for each subject will be recorded.
Measured: Up to 10 days
Number Subjects With Cardiac Complications
The number of subjects experiencing cardiac cardiac complications will be recorded.
Measured: 3 months post enrollment
Number of Patients With Acute Renal Failure
The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine > 0.5 mg/dL from baseline).
Measured: 3 months post enrollment
Hospital Mortality
Number of hospital deaths that occur.
Measured: During hospital stay - up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 201722 Mar 2019

First posted9 Jan 2017 (estimated)
Study start17 May 2017
Primary completion22 Mar 2019
Study completion22 Mar 2019

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 DiabetesStudies of the same condition, open and under way.
More trials run by Emory UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03013985
Sponsor's protocol ID: IRB00091740
Status last verified: Apr 2020
First submitted: 5 Jan 2017
Last updated: 7 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Pasquel FJ, Lansang MC, Khowaja A, Urrutia MA, Cardona S, Albury B, Galindo RJ, Fayfman M, Davis G, Migdal A, Vellanki P, Peng L, Umpierrez GE. A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial. Diabetes Care. 2020 Jun;43(6):1242-1248. doi: 10.2337/dc19-1940. Epub 2020 Apr 9.
PubMed 32273271

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT03013985
Acronym / sponsor ID: IRB00091740
Conditions: Type 2 Diabetes
Keywords: Blood glucose
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: 17 May 2017 (actual)
Primary completion: 22 Mar 2019 (actual)
Study completion: 22 Mar 2019 (actual)
First posted: 9 Jan 2017 (estimated)
Results: Posted 7 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Basal bolus insulin with glargine U300 and glulisine insulin	Experimental	Drug: Glargine U300, Drug: Glulisine InsulinSubjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.
Basal bolus insulin with glargine U100 and glulisine insulin	Active comparator	Drug: Glargine U100, Drug: Glulisine InsulinSubjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Males or females between > 18 years admitted to a general medicine or surgical service.
Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the exception of degludec and glargine U300.
Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).

Key exclusion criteria (6 listed)

Subjects with increased BG concentration, but without a known history of diabetes.
Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, dulaglutide or albiglutide).
Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30 ml/min).
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

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
Glargine U300Also: ToujeoGlargine U300 is a new generation long-acting insulin.	Drug	Basal bolus insulin with glargine U300 and glulisine insulin
Glargine U100Also: LantusGlargine U100 is a long-acting insulin.	Drug	Basal bolus insulin with glargine U100 and glulisine insulin
Glulisine InsulinAlso: ApidraGlulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Drug	Basal bolus insulin with glargine U100 and glulisine insulin, Basal bolus insulin with glargine U300 and glulisine insulin

Primary outcome

Mean Daily Blood Glucose Concentration Inpatient
Time frame: up to 10 days (day of hospital discharge)
The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.
Mean Daily Blood Glucose Concentration After Hospital Discharge
Time frame: assessed from day 11 (day after hospital discharge) up to 3 months
Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.

12 secondary outcomes

Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%
Time frame: up to 3 months post enrollment
Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%
Time frame: up to 3 months post enrollment
Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days
Time frame: Up to 3 days
Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days
Time frame: Up to 5 days
Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days
Time frame: Up to 10 days
Percent of Blood Glucose 70-180 Measured by Point of Care Test
Time frame: 3 months post enrollment
Percent of Subjects With Hypoglycemic Events
Time frame: 3 months post enrollment
Percent of Subjects With Severe Hypoglycemia
Time frame: 3 months post enrollment
Number of Days of Hospital Stay
Time frame: Up to 10 days
Number Subjects With Cardiac Complications
Time frame: 3 months post enrollment
Number of Patients With Acute Renal Failure
Time frame: 3 months post enrollment
Hospital Mortality
Time frame: During hospital stay - up to 10 days

Results and safety

Results posted to the registry on 7 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	108	92
Basal Bolus Insulin With Glargine U100 and Glulisine Insulin	103	84

Primary outcome: Mean Daily Blood Glucose Concentration Inpatient

Time frame: up to 10 days (day of hospital discharge). Mean (Standard Deviation). Unit: mg/dL

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n = 92	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n = 84
Value	186 (40)	184 (46)

Primary outcome: Mean Daily Blood Glucose Concentration After Hospital Discharge

Time frame: assessed from day 11 (day after hospital discharge) up to 3 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n = 41	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n = 45
Value	171.6 (44.8)	164.5 (46.7)

Population analysed: The outpatient has less number of participants compared to the in-hospital part due to a1c less tan required for outpatient part, participants not wanting to continue in the discharge part and/or admission to long term facilities where we were not able to administer study medication.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	21 of 108 (19.4%)	10 of 108 (9.3%)	0 of 108
Basal Bolus Insulin With Glargine U100 and Glulisine Insulin	21 of 103 (20.4%)	18 of 103 (17.5%)	2 of 103

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32273271Pasquel FJ, Lansang MC, Khowaja A, Urrutia MA, Cardona S, Albury B, Galindo RJ, Fayfman M, Davis G, Migdal A, Vellanki P, Peng L, Umpierrez GE. A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial. Diabetes Care. 2020 Jun;43(6):1242-1248. doi: 10.2337/dc19-1940. Epub 2020 Apr 9.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes

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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.

Guillermo Umpierrez, MD principal investigator

Emory University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glargine U300, Glargine U100 and Glulisine Insulin in people with Type 2 Diabetes, run by Emory University at 4 sites 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 3 inclusion and 6 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 7 May 2020). 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?

Mean Daily Blood Glucose Concentration Inpatient (time frame: up to 10 days (day of hospital discharge)). The study lists 2 primary outcomes in all. 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 NCT03013985, 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 7 May 2020.