Diabetes Mellitus, Type 2Phase 4NCT02408120
Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes
A Phase 4 study testing Insulin glargine, Insulin aspart and Supplemental insulin aspart in people with Diabetes Mellitus, Type 2, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin glargine, Insulin aspart and Supplemental insulin aspart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to 11 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma
- Known history of Type 2 diabetes mellitus for >3 months
- Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
- Blood glucose levels between >140 mg and <400 mg/dL without laboratory evidence of diabetic ketoacidosis
Who cannot join
- Hyperglycemia without a history of diabetes
- Subjects with acute critical illness admitted to the ICU or expected to require ICU admission
- Subjects receiving continuous insulin infusion
- Clinically relevant hepatic disease
- Corticosteroid therapy
- Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) <30
- Subjects unable to sign consent
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen
The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.
Read the detailed description
The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin glargine, Insulin aspart, Supplemental insulin aspart
- Keywords
- Hyperglycemia, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
Also called Lantus (glargine)
Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day.
Daily insulin dose will be adjusted as follow:
- If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change
- If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day
- If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day
- If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day
- If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.
Insulin aspartDrug
Also called Novolog
Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held.
Daily insulin dose will be adjusted as follow:
- If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change
- If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day
- If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day
- If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day
- If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.
Supplemental insulin aspartDrug
Also called Novolog
Insulin aspart will be administered following the supplemental insulin scale protocol.
For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows:
- BG >141-180 mg/dL; 2-4 units of insulin aspart
- BG between 181-220 mg/dL; 3-6 units of insulin aspart
- BG between 221-260 mg/dL; 4-8 units of insulin aspart
- BG between 261-300 mg/dL; 5-10 units of insulin aspart
- BG between 301-350 mg/dL; 6-12 units of insulin aspart
- BG between 351-400 mg/dL; 7-14 units of insulin aspart
- BG > 400 mg/dL; 8-16 units of insulin aspart
For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows:
- BG between 261-300 mg/dL; 5-10 units of insulin aspart
- BG between 301-350 mg/dL; 6-12 units of insulin aspart
- BG between 351-400 mg/dL; 7-14 units of insulin aspart
- BG > 400 mg/dL; 8-16 units of insulin aspart
| Study group | Role | What they receive |
|---|---|---|
| Insulin Aspart for BG > 140 mg/dL | Active comparator | Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL. Receives: Drug: Insulin glargine; Drug: Insulin aspart; Drug: Supplemental insulin aspart |
| Insulin Aspart for BG > 260 mg/dL | Active comparator | Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL. Receives: Drug: Insulin glargine; Drug: Insulin aspart; Drug: Supplemental insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily BG Levels
Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.
Measured: 5 days (average time of discharge from the hospital)
Secondary outcomes (10)
Mean Blood Glucose Levels Before Lunch
The blood glucose levels will be assessed prior to lunch using a glucose meter.
Measured: 5 days (average time of discharge from the hospital)
Mean Blood Glucose Levels at Bedtime
The blood glucose levels will be assessed at bedtime using a glucose meter.
Measured: 5 days (average time of discharge from the hospital)
Mean Blood Glucose Levels Before Dinner
The blood glucose levels will be assessed before dinner using a glucose meter.
Measured: 5 days (average time of discharge from the hospital)
Number of Hypoglycemia Events
The number of occurrences of hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.
Measured: 5 days (average time of discharge from the hospital)
Incidence of Hyperglycemia
The number of occurrences of hyperglycemia (blood glucose levels > 260 mg/dL) will be recorded.
Measured: 5 days (average time of discharge from the hospital)
Number of Blood Glucose Readings Within 100-140 mg/dL Range
The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded.
Measured: 5 days (average time of discharge from the hospital)
Average Number of Days of Hospital Stay
The average number of days in the hospital for subjects will be calculated.
Measured: 5 days (average time of discharge from the hospital)
Mortality
The total number of subject deaths during hospital stay will be recorded.
Measured: 5 days (average time of discharge from the hospital)
Number of Subjects That Experienced Hospital Complications
The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury [rise of serum creatinine >0.5 mg/dL (or 50%) of baseline value]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.
Measured: 5 days (average time of discharge from the hospital)
Mean Daily Dose of Insulin
Daily dose of insulin will be recorded
Measured: 5 days (average time of discharge from the hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startOct 2015
- Primary completion11 Dec 2019
- Study completion11 Dec 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 Diabetes Mellitus, Type 2Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priyathama Vellanki, Emory University
- Investigators
- Priyathama Vellanki, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408120
- Sponsor's protocol ID
- IRB00078695
- Status last verified
- Sep 2023
- First submitted
- 27 Mar 2015
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vellanki P, Cardona S, Galindo RJ, Urrutia MA, Pasquel FJ, Davis GM, Fayfman M, Migdal A, Peng L, Umpierrez GE. Efficacy and Safety of Intensive Versus Nonintensive Supplemental Insulin With a Basal-Bolus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Clinical Study. Diabetes Care. 2022 Oct 1;45(10):2217-2223. doi: 10.2337/dc21-1606.
PubMed 35675498
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen
- ClinicalTrials.gov ID
- NCT02408120
- Acronym / sponsor ID
- IRB00078695
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Hyperglycemia, Hypoglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Posted 6 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.
Detailed description
The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Aspart for BG > 140 mg/dL | Active comparator | Drug: Insulin glargine, Drug: Insulin aspart, Drug: Supplemental insulin aspartSubjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL. |
| Insulin Aspart for BG > 260 mg/dL | Active comparator | Drug: Insulin glargine, Drug: Insulin aspart, Drug: Supplemental insulin aspartSubjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma
- Known history of Type 2 diabetes mellitus for >3 months
- Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
- Blood glucose levels between >140 mg and <400 mg/dL without laboratory evidence of diabetic ketoacidosis
Key exclusion criteria (8 listed)
- Hyperglycemia without a history of diabetes
- Subjects with acute critical illness admitted to the ICU or expected to require ICU admission
- Subjects receiving continuous insulin infusion
- Clinically relevant hepatic disease
- Corticosteroid therapy
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 (glargine)Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day. Daily insulin dose will be adjusted as follow: * If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change * If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day * If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day * If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day * If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%. | Drug | Insulin Aspart for BG > 140 mg/dL, Insulin Aspart for BG > 260 mg/dL |
| Insulin aspartAlso: NovologHalf of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held. Daily insulin dose will be adjusted as follow: * If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change * If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day * If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day * If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day * If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%. | Drug | Insulin Aspart for BG > 140 mg/dL, Insulin Aspart for BG > 260 mg/dL |
| Supplemental insulin aspartAlso: NovologInsulin aspart will be administered following the supplemental insulin scale protocol. For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows: * BG >141-180 mg/dL; 2-4 units of insulin aspart * BG between 181-220 mg/dL; 3-6 units of insulin aspart * BG between 221-260 mg/dL; 4-8 units of insulin aspart * BG between 261-300 mg/dL; 5-10 units of insulin aspart * BG between 301-350 mg/dL; 6-12 units of insulin aspart * BG between 351-400 mg/dL; 7-14 units of insulin aspart * BG > 400 mg/dL; 8-16 units of insulin aspart For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows: * BG between 261-300 mg/dL; 5-10 units of insulin aspart * BG between 301-350 mg/dL; 6-12 units of insulin aspart * BG between 351-400 mg/dL; 7-14 units of insulin aspart * BG > 400 mg/dL; 8-16 units of insulin aspart | Drug | Insulin Aspart for BG > 140 mg/dL, Insulin Aspart for BG > 260 mg/dL |
Primary outcome
Mean Daily BG Levels
Time frame: 5 days (average time of discharge from the hospital)
Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.
10 secondary outcomes
Mean Blood Glucose Levels Before Lunch
Time frame: 5 days (average time of discharge from the hospital)
Mean Blood Glucose Levels at Bedtime
Time frame: 5 days (average time of discharge from the hospital)
Mean Blood Glucose Levels Before Dinner
Time frame: 5 days (average time of discharge from the hospital)
Number of Hypoglycemia Events
Time frame: 5 days (average time of discharge from the hospital)
Incidence of Hyperglycemia
Time frame: 5 days (average time of discharge from the hospital)
Number of Blood Glucose Readings Within 100-140 mg/dL Range
Time frame: 5 days (average time of discharge from the hospital)
Average Number of Days of Hospital Stay
Time frame: 5 days (average time of discharge from the hospital)
Mortality
Time frame: 5 days (average time of discharge from the hospital)
Number of Subjects That Experienced Hospital Complications
Time frame: 5 days (average time of discharge from the hospital)
Mean Daily Dose of Insulin
Time frame: 5 days (average time of discharge from the hospital)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35675498Vellanki P, Cardona S, Galindo RJ, Urrutia MA, Pasquel FJ, Davis GM, Fayfman M, Migdal A, Peng L, Umpierrez GE. Efficacy and Safety of Intensive Versus Nonintensive Supplemental Insulin With a Basal-Bolus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Clinical Study. Diabetes Care. 2022 Oct 1;45(10):2217-2223. doi: 10.2337/dc21-1606.
- Individual participant dataSharing planned: No
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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.
Priyathama Vellanki, MD principal investigator
Emory University
2 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 Insulin glargine, Insulin aspart and Supplemental insulin aspart in people with Diabetes Mellitus, Type 2, run by Emory University at 2 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 4 inclusion and 8 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 6 Jan 2021). 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 BG Levels (time frame: 5 days (average time of discharge from the hospital)). 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 NCT02408120, 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 28 Sep 2023.