Type 2 DiabetesPhase 4VIRDICTNCT01143948
Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial
A Phase 4 study testing Glargine & Glulisine, Regular insulin and NPH & regular insulin in people with Type 2 Diabetes and Liver Cirrhosis, run by Cairo University at 1 site in Egypt.
Trial summary
Liver disease is an important cause of death in type 2 diabetes. In the population-based Verona Diabetes Study cirrhosis was the fourth leading cause of death and accounted for 4.4% of diabetes-related deaths. In another prospective cohort study , cirrhosis accounted for 12.5% of deaths in patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Liver Cirrhosis
- What is being tested?
- Glargine & Glulisine, Regular insulin and NPH & regular insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2011to May 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hospitalized type 2 Diabetes Mellitus with liver cirrhosis
- Entry blood glucose (fasting or random) greater than 180 mg%
Who cannot join
- Type 1 Diabetes Mellitus
- Pregnancy
- Steroids: prednisone greater than 7.5mg/day or equivalent
- Serum Creatinine > 3 mg/dl
- Patients in intensive care units.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Internal medicine hospital ,Cairo University
Cairo, Cairo Governorate, 11956
About this study
Official title: Insulin Therapy in the Inpatient Management of Cirrhotic Patients With Type 2 Diabetes
Liver disease is an important cause of death in type 2 diabetes. In the population-based Verona Diabetes Study cirrhosis was the fourth leading cause of death and accounted for 4.4% of diabetes-related deaths. In another prospective cohort study , cirrhosis accounted for 12.5% of deaths in patients with diabetes. In Egypt hepatitis C virus the commonest of cirrhosis here has a prevalence of 9.8% in the population with the greatest burden over national health care bills. Patients with cirrhosis \& type 2 diabetes mellitus are always showing up in all hospital wards without a clear consensus of best management of their hyperglycemia.
Read the detailed description
Best management of hyperglycemia in non-intensive care unit Cirrhotic patients with type 2 diabetes by different insulin regimens either sliding scale regular insulin or basal bolus insulin using NPH \& regular insulin or Glargine \& Glulisine.
- Conditions
- Type 2 Diabetes, Liver Cirrhosis
- Being tested
- Glargine & Glulisine, Regular insulin, NPH & regular insulin
- Keywords
- Diabetes, Cirrhosis, Insulin, Inpatient
- Medical subject headings
- Diabetes Mellitus, Type 2, Liver Cirrhosis, Diabetes Mellitus, Fibrosis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glargine & GlulisineDrug
Also called lantus, apidra
Basal Glargine \& bolus Glulisine
Regular insulinDrug
Also called actrapid
Sliding scale regular insulin
NPH & regular insulinDrug
Also called mixtard
Basal NPH \& bolus regular insulin
| Study group | Role | What they receive |
|---|---|---|
| 15 patient sliding scale regular insulin | Active comparator | Not described Receives: Drug: Regular insulin |
| 15 patient BBI NPH plus regular insulin | Active comparator | Not described Receives: Drug: NPH & regular insulin |
| 15 patients BBI Glargine plus Glulisine | Active comparator | Not described Receives: Drug: Glargine & Glulisine |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal glycemic control in inpatient cirrhotics
Measured: 3-7 days
Secondary outcomes (1)
Incidence of hypoglycemic episodes
Measured: 3-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Cairo 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Ibtisam Z Eissa, MD, Study chair, Cairo UniversityMary N Rizk, MD, Study director, Cairo UniverityAhmad A Khairy, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143948
- Sponsor's protocol ID
- LC-T2D
- Acronym
- VIRDICT
- Status last verified
- Feb 2010
- First submitted
- 10 Jun 2010
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balkau B, Eschwege E, Ducimetiere P, Richard JL, Warnet JM. The high risk of death by alcohol related diseases in subjects diagnosed as diabetic and impaired glucose tolerant: the Paris Prospective Study after 15 years of follow-up. J Clin Epidemiol. 1991;44(6):465-74. doi: 10.1016/0895-4356(91)90209-r.
PubMed 2037851de Marco R, Locatelli F, Zoppini G, Verlato G, Bonora E, Muggeo M. Cause-specific mortality in type 2 diabetes. The Verona Diabetes Study. Diabetes Care. 1999 May;22(5):756-61. doi: 10.2337/diacare.22.5.756.
PubMed 10332677Tolman KG, Fonseca V, Dalpiaz A, Tan MH. Spectrum of liver disease in type 2 diabetes and management of patients with diabetes and liver disease. Diabetes Care. 2007 Mar;30(3):734-43. doi: 10.2337/dc06-1539. No abstract available.
PubMed 17327353
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Therapy in the Inpatient Management of Cirrhotic Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01143948
- Acronym / sponsor ID
- VIRDICT / LC-T2D
- Conditions
- Type 2 Diabetes, Liver Cirrhosis
- Keywords
- Diabetes, Cirrhosis, Insulin, Inpatient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 15 Jun 2010 (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.
Liver disease is an important cause of death in type 2 diabetes. In the population-based Verona Diabetes Study cirrhosis was the fourth leading cause of death and accounted for 4.4% of diabetes-related deaths. In another prospective cohort study , cirrhosis accounted for 12.5% of deaths in patients with diabetes. In Egypt hepatitis C virus the commonest of cirrhosis here has a prevalence of 9.8% in the population with the greatest burden over national health care bills. Patients with cirrhosis \& type 2 diabetes mellitus are always showing up in all hospital wards without a clear consensus of best management of their hyperglycemia.
Detailed description
Best management of hyperglycemia in non-intensive care unit Cirrhotic patients with type 2 diabetes by different insulin regimens either sliding scale regular insulin or basal bolus insulin using NPH \& regular insulin or Glargine \& Glulisine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 patient sliding scale regular insulin | Active comparator | Drug: Regular insulin |
| 15 patient BBI NPH plus regular insulin | Active comparator | Drug: NPH & regular insulin |
| 15 patients BBI Glargine plus Glulisine | Active comparator | Drug: Glargine & Glulisine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Hospitalized type 2 Diabetes Mellitus with liver cirrhosis
- Entry blood glucose (fasting or random) greater than 180 mg%
Key exclusion criteria (5 listed)
- Type 1 Diabetes Mellitus
- Pregnancy
- Steroids: prednisone greater than 7.5mg/day or equivalent
- Serum Creatinine > 3 mg/dl
- Patients in intensive care units.
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 & GlulisineAlso: lantus, apidraBasal Glargine \& bolus Glulisine | Drug | 15 patients BBI Glargine plus Glulisine |
| Regular insulinAlso: actrapidSliding scale regular insulin | Drug | 15 patient sliding scale regular insulin |
| NPH & regular insulinAlso: mixtardBasal NPH \& bolus regular insulin | Drug | 15 patient BBI NPH plus regular insulin |
Primary outcome
optimal glycemic control in inpatient cirrhotics
Time frame: 3-7 days
1 secondary outcome
Incidence of hypoglycemic episodes
Time frame: 3-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
- Background: PubMed 2037851Balkau B, Eschwege E, Ducimetiere P, Richard JL, Warnet JM. The high risk of death by alcohol related diseases in subjects diagnosed as diabetic and impaired glucose tolerant: the Paris Prospective Study after 15 years of follow-up. J Clin Epidemiol. 1991;44(6):465-74. doi: 10.1016/0895-4356(91)90209-r.
- Background: PubMed 10332677de Marco R, Locatelli F, Zoppini G, Verlato G, Bonora E, Muggeo M. Cause-specific mortality in type 2 diabetes. The Verona Diabetes Study. Diabetes Care. 1999 May;22(5):756-61. doi: 10.2337/diacare.22.5.756.
- Results publication: PubMed 17327353Tolman KG, Fonseca V, Dalpiaz A, Tan MH. Spectrum of liver disease in type 2 diabetes and management of patients with diabetes and liver disease. Diabetes Care. 2007 Mar;30(3):734-43. doi: 10.2337/dc06-1539. No abstract available.
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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.
Ibtisam Z Eissa, MD study chair
Cairo University
Mary N Rizk, MD study director
Cairo Univerity
Ahmad A Khairy, MD study director
Cairo 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 Glargine & Glulisine, Regular insulin and NPH & regular insulin in people with Type 2 Diabetes and Liver Cirrhosis, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Jun 2010. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa M Alfishawy, MB BCh (0111183371, mostafa.alfishawy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optimal glycemic control in inpatient cirrhotics (time frame: 3-7 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 NCT01143948, which also lists 3 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 15 Jun 2010.