DiabetesPhase 4COMPARNCT02219750
Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients
A Phase 4 study testing switch twice-daily insulin in people with Diabetes, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- switch twice-daily insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Aug 2016
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women with type 2 diabetes.(World Health Organization classification) > 20 years of age.
- Patients who have received stable doses of any OADs for at least 12 weeks prior to the screening visit.
- treatment with basal insulin plus OADs >3 months with suboptimal glycemic control (HbA1c >7%)
- FBG <130 mg/dl or FBG ≥130 mg/dl, but daily insulin dose >0.7U/kg or had history of nocturnal hypoglycemia
- Patients who are willing and able to cooperate with study and give signed informed consent.
Who cannot join
- Patients with type 1 diabetes.
- History of severe hypoglycemia or hypoglycemia unawareness within prior 6 months.
- Patients who had received any investigational insulin for more than 3 months or who have received investigational insulin treatment within 4 weeks prior to screening visit.
- Patients hypersensitive with insulin analog or its excipients.
- Patients who are currently pregnant/lactating, or who are preparing for pregnancy or lactation.
- Renal dialysis patients, patients with severe liver disease or congestive heart failure
- BMI >40kg/m2
- Excessive insulin resistance (total daily insulin dose>2.0unit/kg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin
Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes
Read the detailed description
This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 140 patients with type 2 diabetes from Mackay Memorial Hospitals and Mackay Memorial Hospital Taitung branch. After enrollment, eligible patients will be randomized in a 1:1 ratio to either Basal-plus therapy(BPT) or Preprandial premix therapy(PPT). The effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period. All study procedure will be conducted after obtaining informed consent.
- Conditions
- Diabetes
- Being tested
- switch twice-daily insulin
- Keywords
- premix insuiln, basal-plus insulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
switch twice-daily insulinDrug
Also called NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®
compare two different insuiln regimen in basal insuln base and premixed insulin.
NovoMix 30, drug class:biphasic insulins Lantus, drug class: long-acting insuiln Levemir, durg class: long-acting insulin NovoRapid, drug class: rapid-acting insulin
| Study group | Role | What they receive |
|---|---|---|
| Preprandial premix therapy | Active comparator | switch twice-daily insulin Preprandial premix therapy mean that transition of advance insulin based on the basal insulin daily total dose at study entry divided into two equal dose of preprandial NovoMix 30. Patient discontinued all pre-study oral antidiabetic drug(OAD), including sulfonylureas, glinides, Thiazolidinedione(TZD) and Dipeptidyl peptidase-4(DPP-4) inhibitor but left metformin alone Receives: Drug: switch twice-daily insulin |
| Basal-plus insulin | Active comparator | switch twice-daily insulin Basal-plus insulin consisted of continued previous basal insulin and add-on once-daily insulin aspart(NovoRapid) before breakfast. The starting dose of insulin aspart was 4 unit(U) before breakfast and continued under previous basal insulin dose. Receives: Drug: switch twice-daily insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
To compare the change in HbA1c from baseline to endpoint for each groups at Week 24
Measured: 24week duration
Secondary outcomes (5)
achieving goal percentage
To compare the proportion of patients achieving HbA1c < 7% at Week 24.
Measured: 24weeks duration
plasma glucose
To compare the changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at Week 24.
Measured: 24 week duration
weight change
To compare the change in body weight at each visit.
Measured: 24 weeks duration
incidence of hypoglcyemia
To evaluate the incidence of self-reported hypoglycemia episodes.
Measured: 24 weeks duration
total insulin dose
To estimate total insulin dose.
Measured: 24 weeks duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Chen Liu, Mackay Memorial Hospital
- Investigators
- Sung-Chen Liu, master, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219750
- Sponsor's protocol ID
- 13MMHISO71,13MMHISO72
- Acronym
- COMPAR
- Status last verified
- Mar 2016
- First submitted
- 14 Aug 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin
- ClinicalTrials.gov ID
- NCT02219750
- Acronym / sponsor ID
- COMPAR / 13MMHISO71,13MMHISO72
- Conditions
- Diabetes
- Keywords
- premix insuiln, basal-plus insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 Aug 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.
Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes
Detailed description
This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 140 patients with type 2 diabetes from Mackay Memorial Hospitals and Mackay Memorial Hospital Taitung branch. After enrollment, eligible patients will be randomized in a 1:1 ratio to either Basal-plus therapy(BPT) or Preprandial premix therapy(PPT). The effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period. All study procedure will be conducted after obtaining informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preprandial premix therapy | Active comparator | Drug: switch twice-daily insulinswitch twice-daily insulin Preprandial premix therapy mean that transition of advance insulin based on the basal insulin daily total dose at study entry divided into two equal dose of preprandial NovoMix 30. Patient discontinued all pre-study oral antidiabetic drug(OAD), including sulfonylureas, glinides, Thiazolidinedione(TZD) and Dipeptidyl peptidase-4(DPP-4) inhibitor but left metformin alone |
| Basal-plus insulin | Active comparator | Drug: switch twice-daily insulinswitch twice-daily insulin Basal-plus insulin consisted of continued previous basal insulin and add-on once-daily insulin aspart(NovoRapid) before breakfast. The starting dose of insulin aspart was 4 unit(U) before breakfast and continued under previous basal insulin dose. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women with type 2 diabetes.(World Health Organization classification) > 20 years of age.
- Patients who have received stable doses of any OADs for at least 12 weeks prior to the screening visit.
- treatment with basal insulin plus OADs >3 months with suboptimal glycemic control (HbA1c >7%)
- FBG <130 mg/dl or FBG ≥130 mg/dl, but daily insulin dose >0.7U/kg or had history of nocturnal hypoglycemia
- Patients who are willing and able to cooperate with study and give signed informed consent.
Key exclusion criteria (8 listed)
- Patients with type 1 diabetes.
- History of severe hypoglycemia or hypoglycemia unawareness within prior 6 months.
- Patients who had received any investigational insulin for more than 3 months or who have received investigational insulin treatment within 4 weeks prior to screening visit.
- Patients hypersensitive with insulin analog or its excipients.
- Patients who are currently pregnant/lactating, or who are preparing for pregnancy or lactation.
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 |
|---|---|---|
| switch twice-daily insulinAlso: NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®compare two different insuiln regimen in basal insuln base and premixed insulin. NovoMix 30, drug class:biphasic insulins Lantus, drug class: long-acting insuiln Levemir, durg class: long-acting insulin NovoRapid, drug class: rapid-acting insulin | Drug | Basal-plus insulin, Preprandial premix therapy |
Primary outcome
HbA1c
Time frame: 24week duration
To compare the change in HbA1c from baseline to endpoint for each groups at Week 24
5 secondary outcomes
achieving goal percentage
Time frame: 24weeks duration
plasma glucose
Time frame: 24 week duration
weight change
Time frame: 24 weeks duration
incidence of hypoglcyemia
Time frame: 24 weeks duration
total insulin dose
Time frame: 24 weeks duration
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 17 Aug 2018.
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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.
Sung-Chen Liu, master principal investigator
Mackay Memorial Hospital
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 switch twice-daily insulin in people with Diabetes, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 8 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 17 Aug 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 Taiwan. 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?
HbA1c (time frame: 24week duration). 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 17 Aug 2018.