Type 2 Diabetes Treated With InsulinPhase 4NCT04739241
Premixed vs Basal Bolus Insulin Therapy in Older Patients With Type 2 Diabetes
A Phase 4 study testing premixed insulin therapy and basal bolus insulin therapy in people with Type 2 Diabetes Treated With Insulin, run by Consorci Sanitari Integral.
Trial summary
The purpose of this study is to compare efficacy and security of premixed insulin treatment vs basal bolus insulin treatment in older patients with poorly controlled type 2 diabetes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- premixed insulin therapy and basal bolus insulin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 24 Jan 2014to 19 Jun 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Outpatients
- Age ≥ 65 years old
- Type 2 diabetes mellitus
- HbA1c ≥9% (74 mmol/mol)
- Previously treated with one or two doses of basal insulin and oral hypoglycaemic agents
Who cannot join
- Severe insulin-resistance
- High doses of corticosteroids
- Chemotherapy treatment
- High comorbidity
- Bad compliance of the treatment
- Frequent severe hypoglycaemia
About this study
Official title: Is Premixed Insulin Therapy an Alternative to Basal Bolus Therapy in Type 2 Diabetes Mellitus People Older Than 65 Years Old: A Pilot Randomised Trial
The purpose of this study is to compare efficacy and security of premixed insulin treatment vs basal bolus insulin treatment in older patients with poorly controlled type 2 diabetes.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- premixed insulin therapy, basal bolus insulin therapy
- Keywords
- premixed insulin therapy, basal-bolus insulin therapy, type 2 diabetes, elderly
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
premixed insulin therapyDrug
Premixed insulin treatment: 30% of the calculated dose was administered before breakfast and before lunch (biphasic insulin lispro 50% or biphasic insulin aspart 50%) and the remaining 40% of the dose before dinner (biphasic insulin lispro 25% or biphasic insulin aspart insulin 30%).
basal bolus insulin therapyDrug
Basal-bolus insulin treatment: 50% dose in insulin glargine and 50% dose in insulin lispro or aspartic, distributed in equal parts in the 3 main meals
| Study group | Role | What they receive |
|---|---|---|
| Group A (experimental arm) | Experimental | Premixed insulin therapy Receives: Drug: premixed insulin therapy |
| Group B (active comparator) | Active comparator | Basal bolus insulin therapy Receives: Drug: basal bolus insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c levels
Change from baseline in HbA1c levels after 12 months of therapy
Measured: 12 months after recruitment
Secondary outcomes (4)
Incidence of hypoglycaemia as an adverse effect of the treatment
Number of hypoglycaemias by month
Measured: every month during the 12-month follow-up
Incidence of dosing errors as a measure of the safety of the treatment
Number of dosing errors by month
Measured: every month during the 12-month follow-up
Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12.
Change from baseline to12 months of therapy using the DTSQ questionnaire of satisfactions with the treatment of diabetes.
Measured: 12-month follow-up
Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12.
Change from baseline to12 months of therapy using the EsDQOL questionnaire of quality of life in diabetic patients
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start24 Jan 2014
- Primary completion20 Apr 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739241
- Sponsor's protocol ID
- 14/11
- Status last verified
- Jun 2018
- First submitted
- 27 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Premixed Insulin Therapy an Alternative to Basal Bolus Therapy in Type 2 Diabetes Mellitus People Older Than 65 Years Old: A Pilot Randomised Trial
- ClinicalTrials.gov ID
- NCT04739241
- Acronym / sponsor ID
- 14/11
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- premixed insulin therapy, basal-bolus insulin therapy, type 2 diabetes, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- 24 Jan 2014 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 4 Feb 2021 (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 purpose of this study is to compare efficacy and security of premixed insulin treatment vs basal bolus insulin treatment in older patients with poorly controlled type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (experimental arm) | Experimental | Drug: premixed insulin therapyPremixed insulin therapy |
| Group B (active comparator) | Active comparator | Drug: basal bolus insulin therapyBasal bolus insulin therapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Outpatients
- Age ≥ 65 years old
- Type 2 diabetes mellitus
- HbA1c ≥9% (74 mmol/mol)
- Previously treated with one or two doses of basal insulin and oral hypoglycaemic agents
Key exclusion criteria (6 listed)
- Severe insulin-resistance
- High doses of corticosteroids
- Chemotherapy treatment
- High comorbidity
- Bad compliance of the treatment
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 |
|---|---|---|
| premixed insulin therapyPremixed insulin treatment: 30% of the calculated dose was administered before breakfast and before lunch (biphasic insulin lispro 50% or biphasic insulin aspart 50%) and the remaining 40% of the dose before dinner (biphasic insulin lispro 25% or biphasic insulin aspart insulin 30%). | Drug | Group A (experimental arm) |
| basal bolus insulin therapyBasal-bolus insulin treatment: 50% dose in insulin glargine and 50% dose in insulin lispro or aspartic, distributed in equal parts in the 3 main meals | Drug | Group B (active comparator) |
Primary outcome
Change in HbA1c levels
Time frame: 12 months after recruitment
Change from baseline in HbA1c levels after 12 months of therapy
4 secondary outcomes
Incidence of hypoglycaemia as an adverse effect of the treatment
Time frame: every month during the 12-month follow-up
Incidence of dosing errors as a measure of the safety of the treatment
Time frame: every month during the 12-month follow-up
Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12.
Time frame: 12-month follow-up
Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12.
Time frame: 12-month follow-up
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 4 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Treated With Insulin
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Not yet recruiting
Transitioning Recently Admitted Patients With Non-Insulin and Insulin-treated Type 2 Diabetes to Innovative Glucose Monitoring
Type 2 Diabetes
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing premixed insulin therapy and basal bolus insulin therapy in people with Type 2 Diabetes Treated With Insulin, run by Consorci Sanitari Integral.
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: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in HbA1c levels (time frame: 12 months after recruitment). 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 4 Feb 2021.