Diabetes MellitusPhase 4NCT02758522

NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens

A Phase 4 study testing Once-daily Insulin, Twice-daily Insulin and Triple-daily Insulin in people with Diabetes Mellitus and Hyperglycemia, run by Hospital Universitario Dr. Jose E. Gonzalez.

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 objective of this study is to compare the therapeutic efficacy of three regimens of insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus, Hyperglycemia
What is being tested?: Once-daily Insulin, Twice-daily Insulin and Triple-daily Insulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: No sites listed yet
Study dates: Oct 2013to Oct 2015
Phase: Phase 4
Are there results?: None posted in the registry

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Admitted to medical services
Persistent blood glucose level > 140 mg/dL
With an expected stay ≥ 48 hours

Who cannot join

Subjects with type 1 diabetes mellitus
Parenteral nutrition
Glucose levels ≥ 400 mg/dL at screening
Diabetic ketoacidosis or non-ketosis hyperosmolar state
Clinically relevant hepatic disease
Glomerular filtration rate ≤ 30 ml/min

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Pregnancy
Terminal disease
Inability to provide informed consent

About this study

The objective of this study is to compare the therapeutic efficacy of three regimens of insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.

Read the detailed description

Patients will be randomly assigned to one of the three treatment regimens. Also, the use of oral antidiabetic drugs would be suspended during their stay at the hospital.

Conditions: Diabetes Mellitus, Hyperglycemia
Being tested: Once-daily Insulin, Twice-daily Insulin, Triple-daily Insulin
Keywords: Diabetes Mellitus, Hospital Hyperglycemia
Medical subject headings: Diabetes Mellitus, Hyperglycemia

What participants receive

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

Once-daily InsulinDrug
Patients will receive NPH insulin in a once-daily regimen. The starting dose is calculate according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the once-daily regimen will be administered subcutaneously before breakfast. Regular insulin subcutaneously wil be given in three equally divided doses before each meal.
Twice-daily InsulinDrug
Patients receive NPH insulin in twice-daily regimen. The starting dose is calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will de fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the twice-daily regimen will be administered subcutaneously before breakfast and before dinner. Regular insulin will be given in three equally divided doses before each meal.
Triple-daily InsulinDrug
Patients receive NPH insulin in a triple-daily regimen. The starting dose was calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the triple daily regimen will be administered subcutaneously before each meal. Regular insulin will be given in three equally divided doses before each meal.

Study groups in NCT02758522
Study group	Role	What they receive
Once-daily insulin	Active comparator	60% of total dose of insulin as NPH insulin in the once-daily regimen was administered subcutaneously before breakfast. Also, 40% in rapid insulin before meals (every 8 hours). Receives: Drug: Once-daily Insulin
Twice-daily insulin	Active comparator	60% of total dose of insulin as NPH insulin in the twice-daily regimen it was given before breakfast and before dinner. Also, 40% in rapid insulin before meals (every 8 hours). Receives: Drug: Twice-daily Insulin
Triple-daily insulin	Active comparator	60% of total dose of insulin as NPH insulin in the triple daily regimen it was administered before each meal. Also, 40% in rapid insulin before meals (every 8 hours). Receives: Drug: Triple-daily Insulin

What is being measured

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

Glycemic control
The achievement of fasting glucose between 70-140 mg/dL and random glucose levels of <180 mg/dL
Measured: Within the time the patient stays at hospital (2 to 14 days)

Secondary outcomes (3)

Differences in the percentage of glucoses in the hypoglycemic range
Hypoglycemia was defined as glucose levels of < 70 mg/dL. Severe hypoglycemia was defined as glucose levels of < 40 mg/dL or the need of assistance.
Measured: Within the time the patient stays at hospital (2 to 14 days)
Total insulin dose required during follow up and at discharge to achieve glycemic control
Measured: Within the time the patient stays at hospital (2 to 14 days)
Differences in hospital stay days
Measured: Within the time the patient stays at hospital (2 to 14 days)

Timeline

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

Oct 2013Oct 2015

First posted2 May 2016 (estimated)
Study startOct 2013
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
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: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02758522
Sponsor's protocol ID: MI13-005
Status last verified: Apr 2016
First submitted: 28 Apr 2016
Last updated: 2 May 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

DeSantis AJ, Schmeltz LR, Schmidt K, O'Shea-Mahler E, Rhee C, Wells A, Brandt S, Peterson S, Molitch ME. Inpatient management of hyperglycemia: the Northwestern experience. Endocr Pract. 2006 Sep-Oct;12(5):491-505. doi: 10.4158/EP.12.5.491.
PubMed 17002924
Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8. No abstract available.
PubMed 19429873
Moghissi E. Hospital management of diabetes: beyond the sliding scale. Cleve Clin J Med. 2004 Oct;71(10):801-8. doi: 10.3949/ccjm.71.10.801.
PubMed 15529485
Pichardo-Lowden AR, Fan CY, Gabbay RA. Management of hyperglycemia in the non-intensive care patient: featuring subcutaneous insulin protocols. Endocr Pract. 2011 Mar-Apr;17(2):249-60. doi: 10.4158/EP10220.RA.
PubMed 21041168
Maynard G, Lee J, Phillips G, Fink E, Renvall M. Improved inpatient use of basal insulin, reduced hypoglycemia, and improved glycemic control: effect of structured subcutaneous insulin orders and an insulin management algorithm. J Hosp Med. 2009 Jan;4(1):3-15. doi: 10.1002/jhm.391.
PubMed 19140173
Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.
PubMed 17513708
ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association consensus statement on inpatient diabetes and glycemic control. Endocr Pract. 2006 Jul-Aug;12(4):458-68. doi: 10.4158/EP.12.4.458. No abstract available.
PubMed 16983798
Mills RD, Schwartz F, Shubrook JH. Evaluation of diabetes management in a rural community hospital. Endocr Pract. 2008 Jan-Feb;14(1):50-5. doi: 10.4158/EP.14.1.50.
PubMed 18238741
Schnipper JL, Ndumele CD, Liang CL, Pendergrass ML. Effects of a subcutaneous insulin protocol, clinical education, and computerized order set on the quality of inpatient management of hyperglycemia: results of a clinical trial. J Hosp Med. 2009 Jan;4(1):16-27. doi: 10.1002/jhm.385.
PubMed 19140191
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S64-71. doi: 10.2337/dc12-s064. No abstract available.
PubMed 22187472
American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
PubMed 22187469

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?

Official record

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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens
ClinicalTrials.gov ID: NCT02758522
Acronym / sponsor ID: MI13-005
Conditions: Diabetes Mellitus, Hyperglycemia
Keywords: Diabetes Mellitus, Hospital Hyperglycemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
Study start: Oct 2013
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 2 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

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

The objective of this study is to compare the therapeutic efficacy of three regimens of insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.

Detailed description

Patients will be randomly assigned to one of the three treatment regimens. Also, the use of oral antidiabetic drugs would be suspended during their stay at the hospital.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Once-daily insulin	Active comparator	Drug: Once-daily Insulin60% of total dose of insulin as NPH insulin in the once-daily regimen was administered subcutaneously before breakfast. Also, 40% in rapid insulin before meals (every 8 hours).
Twice-daily insulin	Active comparator	Drug: Twice-daily Insulin60% of total dose of insulin as NPH insulin in the twice-daily regimen it was given before breakfast and before dinner. Also, 40% in rapid insulin before meals (every 8 hours).
Triple-daily insulin	Active comparator	Drug: Triple-daily Insulin60% of total dose of insulin as NPH insulin in the triple daily regimen it was administered before each meal. Also, 40% in rapid insulin before meals (every 8 hours).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Admitted to medical services
Persistent blood glucose level > 140 mg/dL
With an expected stay ≥ 48 hours

Key exclusion criteria (9 listed)

Subjects with type 1 diabetes mellitus
Parenteral nutrition
Glucose levels ≥ 400 mg/dL at screening
Diabetic ketoacidosis or non-ketosis hyperosmolar state
Clinically relevant hepatic disease

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
Once-daily InsulinPatients will receive NPH insulin in a once-daily regimen. The starting dose is calculate according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the once-daily regimen will be administered subcutaneously before breakfast. Regular insulin subcutaneously wil be given in three equally divided doses before each meal.	Drug	Once-daily insulin
Twice-daily InsulinPatients receive NPH insulin in twice-daily regimen. The starting dose is calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will de fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the twice-daily regimen will be administered subcutaneously before breakfast and before dinner. Regular insulin will be given in three equally divided doses before each meal.	Drug	Twice-daily insulin
Triple-daily InsulinPatients receive NPH insulin in a triple-daily regimen. The starting dose was calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the triple daily regimen will be administered subcutaneously before each meal. Regular insulin will be given in three equally divided doses before each meal.	Drug	Triple-daily insulin

Primary outcome

Glycemic control
Time frame: Within the time the patient stays at hospital (2 to 14 days)
The achievement of fasting glucose between 70-140 mg/dL and random glucose levels of <180 mg/dL

3 secondary outcomes

Differences in the percentage of glucoses in the hypoglycemic range
Time frame: Within the time the patient stays at hospital (2 to 14 days)
Total insulin dose required during follow up and at discharge to achieve glycemic control
Time frame: Within the time the patient stays at hospital (2 to 14 days)
Differences in hospital stay days
Time frame: Within the time the patient stays at hospital (2 to 14 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
Background: PubMed 17002924DeSantis AJ, Schmeltz LR, Schmidt K, O'Shea-Mahler E, Rhee C, Wells A, Brandt S, Peterson S, Molitch ME. Inpatient management of hyperglycemia: the Northwestern experience. Endocr Pract. 2006 Sep-Oct;12(5):491-505. doi: 10.4158/EP.12.5.491.
Background: PubMed 19429873Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8. No abstract available.
Background: PubMed 15529485Moghissi E. Hospital management of diabetes: beyond the sliding scale. Cleve Clin J Med. 2004 Oct;71(10):801-8. doi: 10.3949/ccjm.71.10.801.
Background: PubMed 21041168Pichardo-Lowden AR, Fan CY, Gabbay RA. Management of hyperglycemia in the non-intensive care patient: featuring subcutaneous insulin protocols. Endocr Pract. 2011 Mar-Apr;17(2):249-60. doi: 10.4158/EP10220.RA.
Background: PubMed 19140173Maynard G, Lee J, Phillips G, Fink E, Renvall M. Improved inpatient use of basal insulin, reduced hypoglycemia, and improved glycemic control: effect of structured subcutaneous insulin orders and an insulin management algorithm. J Hosp Med. 2009 Jan;4(1):3-15. doi: 10.1002/jhm.391.
Background: PubMed 17513708Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.
Background: PubMed 16983798ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association consensus statement on inpatient diabetes and glycemic control. Endocr Pract. 2006 Jul-Aug;12(4):458-68. doi: 10.4158/EP.12.4.458. No abstract available.
Background: PubMed 18238741Mills RD, Schwartz F, Shubrook JH. Evaluation of diabetes management in a rural community hospital. Endocr Pract. 2008 Jan-Feb;14(1):50-5. doi: 10.4158/EP.14.1.50.
Background: PubMed 19140191Schnipper JL, Ndumele CD, Liang CL, Pendergrass ML. Effects of a subcutaneous insulin protocol, clinical education, and computerized order set on the quality of inpatient management of hyperglycemia: results of a clinical trial. J Hosp Med. 2009 Jan;4(1):16-27. doi: 10.1002/jhm.385.
Background: PubMed 22187472American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S64-71. doi: 10.2337/dc12-s064. No abstract available.
Background: PubMed 22187469American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Recruiting
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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.

Hector E Tamez-Perez, MD, PhD principal investigator

Facultad de Medicina y Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Universidad Autonoma de Nuevo Leon

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Once-daily Insulin, Twice-daily Insulin and Triple-daily Insulin in people with Diabetes Mellitus and Hyperglycemia, run by Hospital Universitario Dr. Jose E. Gonzalez.

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 9 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 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Glycemic control (time frame: Within the time the patient stays at hospital (2 to 14 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 NCT02758522, which also lists 11 linked publications.

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 2 May 2016.