Type 2 Diabetes MellitusPhase 4NCT02189395
Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting
A Phase 4 study testing NPH and regular insulin and glargine and humalog in people with Type 2 Diabetes Mellitus, run by Riverside University Health System Medical Center at 1 site in United States.
Trial summary
The goal of the current study is to determine difference in glycemic control between traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly encountered in the investigators county hospital… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- NPH and regular insulin and glargine and humalog
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type II diabetes regardless of duration of diagnosis with an admission blood glucose level between 140 mg/dL to 400 mg/dL will be included in the study.
- Other inclusion criteria are as follows:
- age 18-80 years old
- treated with diet alone
- any combination of oral anti-diabetic agents or insulin treatment with any dosage before admission.
Who cannot join
- Hyperglycemia without a known history of diabetes
- H/o recent cardiac surgery (within 6 months)
- Impaired renal function (glomerular filtration rate less than 45)
- History of diabetic ketoacidosis
- Diabetes mellitus type 1
- Pregnancy
Show all 12Show fewer
- Patients on steroid treatment
- Known hypopituitarism or adrenal insufficiency
- Known hypoglycemia of unawareness
- Length of stay <48 h
- And severe liver disease and patent admitted in intensive care unit.
- Patients already received an insulin dose greater than 0.5 units/kg body weight after admission prior to initiation of study protocol will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riverside County Regional Medical Center
Moreno Valley, California, 92555
About this study
The goal of the current study is to determine difference in glycemic control between traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly encountered in the investigators county hospital setting which include newly diagnosed type 2 patients and patients on relatively high dose of insulin (dose >0.4 units/kg body weight. Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose. Secondary outcome is to measure number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.
Read the detailed description
The effect of insulin depends not only on the pharmacokinetics and pharmacodynamics of a particular preparation, but also on patient specific factors which includes state of inflammation, obesity etc. Although effect on glucose disposal is the central to insulin action, there could be differences of insulin action on other metabolic parameters. It is not known if there is a difference in suppression of inflammation with improved glycemic control which could vary with analog insulin. It is unknown if natural insulin (NPH, recombinant human insulin with protamine) differs from insulin analogs (glargine and detemir, made by substituting amino acid in the native sequence) in terms of metabolic outcome other than glucose disposal.
At this point it is uncertain if there is any clear benefit of use of lantus over NPH in inpatient glycemic management. Currently, both lantus and NPH based regimen is practiced in inpatient hospital setting. Current practice of inpatient insulin regimen is based more on familiarity of physicians with a particular insulin type and personal preference rather than evidenced based knowledge. Lantus is an expensive insulin preparation compared to NPH with uncertain benefit in inpatient setting. Current research proposal will compare this two insulin based regimen in the management of diabetes of hospitalized patients. Information obtained through this research will guide the investigators practice in this institution as well as in other institutions.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- NPH and regular insulin, glargine and humalog
- Keywords
- Type 2 diabetes, Uncontrolled blood glucose, insulin, glargine, NPH
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPH and regular insulinDrug
glargine and humalogDrug
| Study group | Role | What they receive |
|---|---|---|
| NPH and regular insuline group | Experimental | For the group receiving NPH and regular 2/3 and 1/3 formula will be followed. If Nil per os (NPO), patient will receive NPH twice daily but AM dose will equal to PM dose. Regular insulin given along with NPH will be held while patient is NPO. A correctional dose of regular insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they could also receive correctional doses of regular insulin. Correctional insulin could be given four times daily with meals or at bedtime. Receives: Drug: NPH and regular insulin |
| glargine and humalog group | Active comparator | Half of the total insulin dose will be given as glargine once daily, either in the AM or in the PM, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as humalog; doses were divided equally between breakfast, lunch, and dinner. An additional correctional dose of humalog will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and could also receive correctional doses of humalog. Correctional humalog could be given four times daily with meals or at bedtime. Receives: Drug: glargine and humalog |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in glycemic control between treatment groups as measured by the mean daily blood glucose
Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose
Measured: Duration of hospital stay, up to 24 weeks
Secondary outcomes (1)
number of hypoglycemic events
number of hypoglycemic events
Measured: duration of hospital stay, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: difficulty in subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riverside University Health System Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iqbal Munir, MD, PhD, Riverside University Health System Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189395
- Sponsor's protocol ID
- 437860
- Status last verified
- Sep 2017
- First submitted
- 9 Jul 2014
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting
- ClinicalTrials.gov ID
- NCT02189395
- Acronym / sponsor ID
- 437860
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes, Uncontrolled blood glucose, insulin, glargine, NPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in subject recruitment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riverside University Health System Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 14 Jul 2014 (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 goal of the current study is to determine difference in glycemic control between traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly encountered in the investigators county hospital setting which include newly diagnosed type 2 patients and patients on relatively high dose of insulin (dose >0.4 units/kg body weight. Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose. Secondary outcome is to measure number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.
Detailed description
The effect of insulin depends not only on the pharmacokinetics and pharmacodynamics of a particular preparation, but also on patient specific factors which includes state of inflammation, obesity etc. Although effect on glucose disposal is the central to insulin action, there could be differences of insulin action on other metabolic parameters. It is not known if there is a difference in suppression of inflammation with improved glycemic control which could vary with analog insulin. It is unknown if natural insulin (NPH, recombinant human insulin with protamine) differs from insulin analogs (glargine and detemir, made by substituting amino acid in the native sequence) in terms of metabolic outcome other than glucose disposal.
At this point it is uncertain if there is any clear benefit of use of lantus over NPH in inpatient glycemic management. Currently, both lantus and NPH based regimen is practiced in inpatient hospital setting. Current practice of inpatient insulin regimen is based more on familiarity of physicians with a particular insulin type and personal preference rather than evidenced based knowledge. Lantus is an expensive insulin preparation compared to NPH with uncertain benefit in inpatient setting. Current research proposal will compare this two insulin based regimen in the management of diabetes of hospitalized patients. Information obtained through this research will guide the investigators practice in this institution as well as in other institutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPH and regular insuline group | Experimental | Drug: NPH and regular insulinFor the group receiving NPH and regular 2/3 and 1/3 formula will be followed. If Nil per os (NPO), patient will receive NPH twice daily but AM dose will equal to PM dose. Regular insulin given along with NPH will be held while patient is NPO. A correctional dose of regular insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they could also receive correctional doses of regular insulin. Correctional insulin could be given four times daily with meals or at bedtime. |
| glargine and humalog group | Active comparator | Drug: glargine and humalogHalf of the total insulin dose will be given as glargine once daily, either in the AM or in the PM, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as humalog; doses were divided equally between breakfast, lunch, and dinner. An additional correctional dose of humalog will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and could also receive correctional doses of humalog. Correctional humalog could be given four times daily with meals or at bedtime. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type II diabetes regardless of duration of diagnosis with an admission blood glucose level between 140 mg/dL to 400 mg/dL will be included in the study.
- Other inclusion criteria are as follows:
Key exclusion criteria (12 listed)
- Hyperglycemia without a known history of diabetes
- H/o recent cardiac surgery (within 6 months)
- Impaired renal function (glomerular filtration rate less than 45)
- History of diabetic ketoacidosis
- Diabetes mellitus type 1
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 |
|---|---|---|
| NPH and regular insulin | Drug | NPH and regular insuline group |
| glargine and humalog | Drug | glargine and humalog group |
Primary outcome
difference in glycemic control between treatment groups as measured by the mean daily blood glucose
Time frame: Duration of hospital stay, up to 24 weeks
Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose
1 secondary outcome
number of hypoglycemic events
Time frame: duration of hospital stay, up to 24 weeks
Results and safety
The study was stopped early (reason given: difficulty in subject recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NPH and regular insulin and glargine and humalog in people with Type 2 Diabetes Mellitus, run by Riverside University Health System 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 28 Sep 2017. 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 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 was stopped early (reason given: difficulty in subject recruitment). Results are not available in the source record.
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?
difference in glycemic control between treatment groups as measured by the mean daily blood glucose (time frame: Duration of hospital stay, up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2017.