Chronic Kidney DiseasesNCT05219942
Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis
A study testing Glargine and normal saline in people with Chronic Kidney Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study aims to compare between the use of continuous low dose insulin infusion versus co-administration of low dose continuous insulin infusion and early subcutaneous insulin glargine in diabetic ketoacidosis patients with chronic renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Glargine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to Jul 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients.
- Type I and type II diabetes mellitus.
- Patients on insulin and/or oral hypoglycemic therapy.
- Duration of diabetes more than 5 years.
- Medical and surgical patients.
Who cannot join
- Severe persistent hypotension (SBP <80 inspite of receiving 1000ml of normal saline).
- Acute myocardial infarction.
- Progressive renal failure or end stage renal disease defined as eGFR < 15ml/min.
- Liver cell failure.
- Pregnancy.
- Need for emergency surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11566
Wael A ElSwefi, MD, 00201114811883, waelelswefi@yahoo.com
About this study
Official title: Outcome of Using Long Acting Glargine Insulin With Low Dose Regular Insulin Infusion in Diabetic Ketoacidosis Patients :A Comparative Study
The study aims to compare between the use of continuous low dose insulin infusion versus co-administration of low dose continuous insulin infusion and early subcutaneous insulin glargine in diabetic ketoacidosis patients with chronic renal impairment. aim to investigate the effect of using the long acting insulin analogue glargine on the resolution time of diabetic ketoacidosis in renal impairment patients who have altered insulin pharmacokinetics and pharmacodynamics and the rate of adverse effects of this approach
Read the detailed description
Diabetic ketoacidosis (DKA) is one of the most common and grave acute complications of diabetes and is a significant cause of morbidity and mortality.
The current available guidelines state that the most effective means of insulin delivery during DKA is a continuous low dose infusion of regular insulin. The patients must be admitted to the ICU for frequent and close monitoring .In addition to insulin infusion, correction of dehydration, and electrolyte and acid base disorders is achieved together with identification and treatment of co-morbid precipitating factors .
"The Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis" recommends continuation of a long-acting insulin analogue such as insulin glargine during the initial management of DKA because it provides background insulin when the intravenous insulin is discontinue.
Administering basal insulin concomitantly with regular insulin infusion was found to be well tolerated, associated with faster resolution of acidosis without any adverse effects; patients required a shorter duration of intravenous insulin infusion and had a lower total dose of intravenous insulin and significantly decreased hyperglycemia after discontinuation of the intravenous insulin .
- Conditions
- Chronic Kidney Diseases
- Being tested
- Glargine, normal saline
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlargineDrug
Also called insulin
regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous Glargine insulin (made by Sanofi®) within the first 2 hours of ICU admission. The dose of insulin glargine will be adjusted according to the calculated (eGFR > 90 dose = 0.27 IU/kg/day, eGFR 60-89 dose = 0.25 IU/kg/day, eGFR <60 dose = 0.19 IU/kg/day.
normal salineOther
regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous saline instead of insulin glargine will be given in the control group.
| Study group | Role | What they receive |
|---|---|---|
| low dose insulin infusion +Subcutaneous saline | Placebo comparator | low dose insulin infusion +Subcutaneous saline Receives: Other: normal saline |
| low dose insulin infusion +subcutaneous Glargine insulin | Active comparator | low dose insulin infusion +subcutaneous Glargine insulin Receives: Drug: Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time to reversal of diabetic ketoacidosis
Resolution of DKA is defined as blood sugar <200mg/dl plus any two of serum bicarbonate ≥15,pH>7.3, and anion gap less than or equal to 12
Measured: 48 hours
Total crystalline insulin consumption
Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Dec 2020
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219942
- Sponsor's protocol ID
- R 103/ 2020
- Status last verified
- Jun 2022
- First submitted
- 9 Jan 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barski L, Kezerle L, Zeller L, Zektser M, Jotkowitz A. New approaches to the use of insulin in patients with diabetic ketoacidosis. Eur J Intern Med. 2013 Apr;24(3):213-6. doi: 10.1016/j.ejim.2013.01.014. Epub 2013 Feb 8.
PubMed 23395363Barski L, Brandstaetter E, Sagy I, Jotkowitz A. Basal insulin for the management of diabetic ketoacidosis. Eur J Intern Med. 2018 Jan;47:14-16. doi: 10.1016/j.ejim.2017.08.025. Epub 2017 Aug 31.
PubMed 28864157Chapter 1: Definition and classification of CKD. Kidney Int Suppl (2011). 2013 Jan;3(1):19-62. doi: 10.1038/kisup.2012.64. No abstract available.
PubMed 25018975Savage MW, Dhatariya KK, Kilvert A, Rayman G, Rees JA, Courtney CH, Hilton L, Dyer PH, Hamersley MS; Joint British Diabetes Societies. Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis. Diabet Med. 2011 May;28(5):508-15. doi: 10.1111/j.1464-5491.2011.03246.x.
PubMed 21255074Svensson M, Yu ZW, Eriksson JW. A small reduction in glomerular filtration is accompanied by insulin resistance in type I diabetes patients with diabetic nephrophathy. Eur J Clin Invest. 2002 Feb;32(2):100-9. doi: 10.1046/j.1365-2362.2002.00949.x.
PubMed 11895456
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Using Long Acting Glargine Insulin With Low Dose Regular Insulin Infusion in Diabetic Ketoacidosis Patients :A Comparative Study
- ClinicalTrials.gov ID
- NCT05219942
- Acronym / sponsor ID
- R 103/ 2020
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 2 Feb 2022 (actual)
- 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 study aims to compare between the use of continuous low dose insulin infusion versus co-administration of low dose continuous insulin infusion and early subcutaneous insulin glargine in diabetic ketoacidosis patients with chronic renal impairment. aim to investigate the effect of using the long acting insulin analogue glargine on the resolution time of diabetic ketoacidosis in renal impairment patients who have altered insulin pharmacokinetics and pharmacodynamics and the rate of adverse effects of this approach
Detailed description
Diabetic ketoacidosis (DKA) is one of the most common and grave acute complications of diabetes and is a significant cause of morbidity and mortality.
The current available guidelines state that the most effective means of insulin delivery during DKA is a continuous low dose infusion of regular insulin. The patients must be admitted to the ICU for frequent and close monitoring .In addition to insulin infusion, correction of dehydration, and electrolyte and acid base disorders is achieved together with identification and treatment of co-morbid precipitating factors .
"The Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis" recommends continuation of a long-acting insulin analogue such as insulin glargine during the initial management of DKA because it provides background insulin when the intravenous insulin is discontinue.
Administering basal insulin concomitantly with regular insulin infusion was found to be well tolerated, associated with faster resolution of acidosis without any adverse effects; patients required a shorter duration of intravenous insulin infusion and had a lower total dose of intravenous insulin and significantly decreased hyperglycemia after discontinuation of the intravenous insulin .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose insulin infusion +Subcutaneous saline | Placebo comparator | Other: normal salinelow dose insulin infusion +Subcutaneous saline |
| low dose insulin infusion +subcutaneous Glargine insulin | Active comparator | Drug: Glarginelow dose insulin infusion +subcutaneous Glargine insulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients.
- Type I and type II diabetes mellitus.
- Patients on insulin and/or oral hypoglycemic therapy.
- Duration of diabetes more than 5 years.
- Medical and surgical patients.
Key exclusion criteria (6 listed)
- Severe persistent hypotension (SBP <80 inspite of receiving 1000ml of normal saline).
- Acute myocardial infarction.
- Progressive renal failure or end stage renal disease defined as eGFR < 15ml/min.
- Liver cell failure.
- Pregnancy.
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 |
|---|---|---|
| GlargineAlso: insulinregular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous Glargine insulin (made by Sanofi®) within the first 2 hours of ICU admission. The dose of insulin glargine will be adjusted according to the calculated (eGFR > 90 dose = 0.27 IU/kg/day, eGFR 60-89 dose = 0.25 IU/kg/day, eGFR <60 dose = 0.19 IU/kg/day. | Drug | low dose insulin infusion +subcutaneous Glargine insulin |
| normal salineregular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous saline instead of insulin glargine will be given in the control group. | Other | low dose insulin infusion +Subcutaneous saline |
Primary outcome
Mean time to reversal of diabetic ketoacidosis
Time frame: 48 hours
Resolution of DKA is defined as blood sugar <200mg/dl plus any two of serum bicarbonate ≥15,pH>7.3, and anion gap less than or equal to 12
Total crystalline insulin consumption
Time frame: 48 hours
Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Background: PubMed 23395363Barski L, Kezerle L, Zeller L, Zektser M, Jotkowitz A. New approaches to the use of insulin in patients with diabetic ketoacidosis. Eur J Intern Med. 2013 Apr;24(3):213-6. doi: 10.1016/j.ejim.2013.01.014. Epub 2013 Feb 8.
- Background: PubMed 28864157Barski L, Brandstaetter E, Sagy I, Jotkowitz A. Basal insulin for the management of diabetic ketoacidosis. Eur J Intern Med. 2018 Jan;47:14-16. doi: 10.1016/j.ejim.2017.08.025. Epub 2017 Aug 31.
- Background: PubMed 25018975Chapter 1: Definition and classification of CKD. Kidney Int Suppl (2011). 2013 Jan;3(1):19-62. doi: 10.1038/kisup.2012.64. No abstract available.
- Background: PubMed 21255074Savage MW, Dhatariya KK, Kilvert A, Rayman G, Rees JA, Courtney CH, Hilton L, Dyer PH, Hamersley MS; Joint British Diabetes Societies. Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis. Diabet Med. 2011 May;28(5):508-15. doi: 10.1111/j.1464-5491.2011.03246.x.
- Background: PubMed 11895456Svensson M, Yu ZW, Eriksson JW. A small reduction in glomerular filtration is accompanied by insulin resistance in type I diabetes patients with diabetic nephrophathy. Eur J Clin Invest. 2002 Feb;32(2):100-9. doi: 10.1046/j.1365-2362.2002.00949.x.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glargine and normal saline in people with Chronic Kidney Diseases, run by Ain Shams 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 5 inclusion and 6 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 7 Jun 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Eeman A Bayoumi, MD (0021001635744, eeman_aboubakr@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time to reversal of diabetic ketoacidosis (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 NCT05219942, which also lists 5 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 7 Jun 2022.