HyperglycemiaPhase 4NCT02278913
Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay
A Phase 4 study testing Basal Bolus (Glargine and Glulisine) and Human Insulin in people with Hyperglycemia and Diabetes, run by Universidad Nacional de Asunción at 1 site in Paraguay.
Trial summary
Few randomized studies have focused on the optimal management of non-ICU patients with type 2 diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen with analogs and human insulins in general medicine patients admitted to a University Hospital in Asuncion, Paraguay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Diabetes
- What is being tested?
- Basal Bolus (Glargine and Glulisine) and Human Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteParaguay
- Study dates
- Apr 2009to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- History of type 2 diabetes > 1 month
- Treatment with diet alone, any combination of oral antidiabetic agents, and/or insulin prior to admission
- Absence of diabetic ketoacidosis
Who cannot join
- No history of diabetes
- Subjects expected to undergo surgery during the hospitalization course
- Clinically relevant hepatic disease
- Impaired renal function (serum creatinine ≥ 3.0 mg/dL)
- Pregnancy
- Any mental condition rendering the subject unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,
Asunción
About this study
Official title: Basal Bolus Regimen With Insulin Analogs Versus Human Insulin in Medical Patients With Type 2 Diabetes: A Randomized Controlled Trial in Paraguay
Few randomized studies have focused on the optimal management of non-ICU patients with type 2 diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen with analogs and human insulins in general medicine patients admitted to a University Hospital in Asuncion, Paraguay.
Read the detailed description
Few randomized intervention inpatient trials have been conducted in Latin America to determine optimal treatment regimens for patients with type 2 diabetes. In the absence of regional guidelines, most international societies in Latin America recommend following international guidelines for the management of hospitalized patients with diabetes. However, hospital resources, admission cause and inpatient glycemic control differ among countries. In the US, the leading cause of admission to the hospital in patients with diabetes is cardiovascular disease, whereas infections and acute complications of diabetes are more common than cardiovascular disease in some countries. The safety and efficacy of insulin regimens in non-ICU setting in Latin countries have not been determined. Objective: to compare the efficacy and safety of a basal-bolus regimen using insulin analogs with glargine once daily plus glulisine before meals to human insulin with NPH twice daily and regular insulin before meals in medicine patients with type 2 diabetes Outcome measures. To determine differences in glycemic control between groups as measured by mean daily BG concentration during the hospital stay. Secondary outcomes included differences between treatment groups in any of the following measures: number of hypoglycemic events (BG <70 mg/dL and <40 mg/dL), total daily dose of insulin, length of hospital stay, hospital complications and mortality.
- Conditions
- Hyperglycemia, Diabetes
- Being tested
- Basal Bolus (Glargine and Glulisine), Human Insulin
- Keywords
- inpatient, hospital, randomized trial, diabetes, analogs, human insulin
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basal Bolus (Glargine and Glulisine)Drug
Also called Glargine and glulisine
Glargine daily + Glulisine before meals
Human InsulinDrug
Also called NPH and regular
NPH twice a day + Regular insulin before meals
| Study group | Role | What they receive |
|---|---|---|
| Basal Bolus (Glargine and Glulisine) | Experimental | Basal bolus: with Insulin analogs (glargine and glulisine), 50% of total daily dose as glargine given before breakfast and 50% as glulisine insulin given in three equally divided doses before each meal. Receives: Drug: Basal Bolus (Glargine and Glulisine) |
| Human Insulin | Active comparator | Human insulin: NPH and regular insulin: 2/3 of total daily dose as NPH and 1/3 as regular insulin. NPH insulin dose given as 2/3 in the morning before breakfast and 1/3 before dinner. Regular insulin given in three equally divided doses before each meal Receives: Drug: Human Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
The primary outcome of the study is to determine differences in glycemic control as measured by mean daily BG concentration between human insulin (NPH + Regular insulin) and basal bolus therapy (glargine once daily + glulisine)
Measured: During hospitalization, an expected average of 10 days
Secondary outcomes (4)
Hypoglycemia
Number of hypoglycemic events (<70 mg/dl) and severe hypoglycemic events (<40 mg/dl)
Measured: During hospitalization, an expected average of 10 days
Insulin dose
Total daily dose of insulin
Measured: During hospitalization, an expected average of 10 days
Length of stay
Duration of hospitalization
Measured: During hospitalization, an expected average of 10 days
Mortality
Mortality is defined as death occurring during admission
Measured: During hospitalization, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Asunción
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvio Dario Bueno Colman, Universidad Nacional de Asunción
- Investigators
- Elvio Bueno, MD, Principal investigator, Universida Nacional de Asuncion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278913
- Sponsor's protocol ID
- P 08/09
- Status last verified
- Oct 2014
- First submitted
- 24 Oct 2014
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Bolus Regimen With Insulin Analogs Versus Human Insulin in Medical Patients With Type 2 Diabetes: A Randomized Controlled Trial in Paraguay
- ClinicalTrials.gov ID
- NCT02278913
- Acronym / sponsor ID
- P 08/09
- Conditions
- Hyperglycemia, Diabetes
- Keywords
- inpatient, hospital, randomized trial, diabetes, analogs, human insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Universidad Nacional de AsunciónUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Oct 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.
Few randomized studies have focused on the optimal management of non-ICU patients with type 2 diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen with analogs and human insulins in general medicine patients admitted to a University Hospital in Asuncion, Paraguay.
Detailed description
Few randomized intervention inpatient trials have been conducted in Latin America to determine optimal treatment regimens for patients with type 2 diabetes. In the absence of regional guidelines, most international societies in Latin America recommend following international guidelines for the management of hospitalized patients with diabetes. However, hospital resources, admission cause and inpatient glycemic control differ among countries. In the US, the leading cause of admission to the hospital in patients with diabetes is cardiovascular disease, whereas infections and acute complications of diabetes are more common than cardiovascular disease in some countries. The safety and efficacy of insulin regimens in non-ICU setting in Latin countries have not been determined. Objective: to compare the efficacy and safety of a basal-bolus regimen using insulin analogs with glargine once daily plus glulisine before meals to human insulin with NPH twice daily and regular insulin before meals in medicine patients with type 2 diabetes Outcome measures. To determine differences in glycemic control between groups as measured by mean daily BG concentration during the hospital stay. Secondary outcomes included differences between treatment groups in any of the following measures: number of hypoglycemic events (BG <70 mg/dL and <40 mg/dL), total daily dose of insulin, length of hospital stay, hospital complications and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basal Bolus (Glargine and Glulisine) | Experimental | Drug: Basal Bolus (Glargine and Glulisine)Basal bolus: with Insulin analogs (glargine and glulisine), 50% of total daily dose as glargine given before breakfast and 50% as glulisine insulin given in three equally divided doses before each meal. |
| Human Insulin | Active comparator | Drug: Human InsulinHuman insulin: NPH and regular insulin: 2/3 of total daily dose as NPH and 1/3 as regular insulin. NPH insulin dose given as 2/3 in the morning before breakfast and 1/3 before dinner. Regular insulin given in three equally divided doses before each meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- History of type 2 diabetes > 1 month
- Treatment with diet alone, any combination of oral antidiabetic agents, and/or insulin prior to admission
- Absence of diabetic ketoacidosis
Key exclusion criteria (6 listed)
- No history of diabetes
- Subjects expected to undergo surgery during the hospitalization course
- Clinically relevant hepatic disease
- Impaired renal function (serum creatinine ≥ 3.0 mg/dL)
- 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 |
|---|---|---|
| Basal Bolus (Glargine and Glulisine)Also: Glargine and glulisineGlargine daily + Glulisine before meals | Drug | Basal Bolus (Glargine and Glulisine) |
| Human InsulinAlso: NPH and regularNPH twice a day + Regular insulin before meals | Drug | Human Insulin |
Primary outcome
Glycemic control
Time frame: During hospitalization, an expected average of 10 days
The primary outcome of the study is to determine differences in glycemic control as measured by mean daily BG concentration between human insulin (NPH + Regular insulin) and basal bolus therapy (glargine once daily + glulisine)
4 secondary outcomes
Hypoglycemia
Time frame: During hospitalization, an expected average of 10 days
Insulin dose
Time frame: During hospitalization, an expected average of 10 days
Length of stay
Time frame: During hospitalization, an expected average of 10 days
Mortality
Time frame: During hospitalization, an expected average of 10 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 30 Oct 2014.
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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.
Elvio Bueno, MD principal investigator
Universida Nacional de Asuncion
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 Basal Bolus (Glargine and Glulisine) and Human Insulin in people with Hyperglycemia and Diabetes, run by Universidad Nacional de Asunción at 1 site in Paraguay.
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 4 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: finished, as of the sponsor's last update on 30 Oct 2014. 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 Paraguay. 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 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: During hospitalization, an expected average of 10 days). 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 30 Oct 2014.