DiabetesPhase 4ICHONCT01101867

Prandial Insulin Dosing in Hospitalized Patients

A Phase 4 study testing Aspart fixed dose and Aspart flexible dose in people with Diabetes and Admitting Hospital, run by Kathleen Dungan at 1 site 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 determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes, Admitting Hospital, Non-critically Ill
What is being tested?: Aspart fixed dose and Aspart flexible dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Mar 2013
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

general medical or minor surgical hospitalized patients
type 2 diabetes
blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment

Who cannot join

• Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).
Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds.
Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing.
Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely
Prolonged (>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable.
Patients for whom expected length of stay will be less than 48 hours

Show all 13Show fewer

Patients using subcutaneous insulin pumps
Diabetic ketoacidosis
End-stage renal disease on dialysis
End-stage liver disease with cirrhosis
Mental conditions precluding informed consent
Potentially sensitive admissions: prisoners, HIV, suicidality
Unable to give consent in English

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes

The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Read the detailed description

The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Conditions: Diabetes, Admitting Hospital, Non-critically Ill
Being tested: Aspart fixed dose, Aspart flexible dose
Keywords: diabetes, glucose, hospital
Medical subject headings: Diabetes Mellitus

What participants receive

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

Aspart fixed doseDrug
Also called Novolog
fixed dose
Aspart flexible doseDrug
Also called Novolog
dose based upon carbohydrate intake and total daily requirements

Study groups in NCT01101867
Study group	Role	What they receive
Aspart flexible dose	Experimental	aspart dose determined based upon carbohydrate intake. Receives: Drug: Aspart flexible dose
Aspart fixed dose	Active comparator	fixed meal dose of aspart (based upon weight or total daily insulin dose) Receives: Drug: Aspart fixed dose

What is being measured

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

Mean Glucose
Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3
Measured: day 3

Secondary outcomes (5)

Postprandial Glucose
Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.
Measured: day 3
Hypoglycemia
Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)
Measured: 72 hour
Change in Glucose
Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1.
Measured: 72 hour
Treatment Satisfaction
treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score.
Measured: day 3
1,5-anhydroglucitol Change
change in short-term measure of glycemia
Measured: day 1 to day 3

Timeline

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

Jun 2010Mar 2013

First posted12 Apr 2010 (estimated)
Study startJun 2010
Primary completionJun 2012
Study completionMar 2013

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.
Other trials for DiabetesStudies 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: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01101867
Sponsor's protocol ID: Novo Nordisk xxxx
Acronym: ICHO
Status last verified: Jan 2018
First submitted: 8 Apr 2010
Last updated: 31 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes
ClinicalTrials.gov ID: NCT01101867
Acronym / sponsor ID: ICHO / Novo Nordisk xxxx
Conditions: Diabetes, Admitting Hospital, Non-critically Ill
Keywords: diabetes, glucose, hospital
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Kathleen DunganUniversity, hospital or other
Collaborators: Novo Nordisk A/S
Study start: Jun 2010
Primary completion: Jun 2012 (actual)
Study completion: Mar 2013 (actual)
First posted: 12 Apr 2010 (estimated)
Results: Posted 2 Jul 2013

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 determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Detailed description

Study design

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

Arm	Type	Receives
Aspart flexible dose	Experimental	Drug: Aspart flexible doseaspart dose determined based upon carbohydrate intake.
Aspart fixed dose	Active comparator	Drug: Aspart fixed dosefixed meal dose of aspart (based upon weight or total daily insulin dose)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

general medical or minor surgical hospitalized patients
type 2 diabetes
blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment

Key exclusion criteria (13 listed)

• Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).

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
Aspart fixed doseAlso: Novologfixed dose	Drug	Aspart fixed dose
Aspart flexible doseAlso: Novologdose based upon carbohydrate intake and total daily requirements	Drug	Aspart flexible dose

Primary outcome

Mean Glucose
Time frame: day 3
Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3

5 secondary outcomes

Postprandial Glucose
Time frame: day 3
Hypoglycemia
Time frame: 72 hour
Change in Glucose
Time frame: 72 hour
Treatment Satisfaction
Time frame: day 3
1,5-anhydroglucitol Change
Time frame: day 1 to day 3

Results and safety

Results posted to the registry on 2 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Flexible Dose	63	62
Fixed Dose	63	59

Primary outcome: Mean Glucose

Time frame: day 3. Mean (Standard Deviation). Unit: mg/dl

Measure	Flexible Dose n = 42	Fixed Dose n = 37
Value	158 (47)	171 (49)

Population analysed: Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 72 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flexible Dose	0 of 62 (0%)	24 of 62 (38.7%)	Not reported
Fixed Dose	0 of 59 (0%)	14 of 59 (23.7%)	Not reported

Limitations and caveats (from the sponsor): Miscalculation of meal doses, mistimed doses, lack of complete documentation of carbohydrate intake, and dosing conducted by an experienced clinician may have contributed to the findings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes

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.

Kathleen M Dungan, MD principal investigator

Ohio State University

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 Aspart fixed dose and Aspart flexible dose in people with Diabetes and Admitting Hospital, run by Kathleen Dungan 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 3 inclusion and 13 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 31 Jan 2018. 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?

Yes. Results are posted in the registry (first posted 2 Jul 2013). 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 Glucose (time frame: day 3). 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 NCT01101867.

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 31 Jan 2018.