Type 2 Diabetes MellitusPhase 4NCT03112538
Improving Glycaemic Control in Malaysian Patients With Type 2 Diabetes Mellitus With Insulin Pump Therapy
A Phase 4 study testing Insulin Pump and Multiple daily injections of insulin in people with Type 2 Diabetes Mellitus, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
Trial summary
The purpose of this study is to evaluate the comparative efficacy of insulin pump therapy versus multiple daily injections in insulin-taking type 2 diabetes mellitus who are sub-optimally controlled with premixed insulin regimen. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin Pump and Multiple daily injections of insulin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteMalaysia
- Study dates
- Jan 2016to Dec 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CRITERIA FOR INCLUSION AT SCREENING
- Diagnosed with type 2 Diabetes Mellitus, as per Investigator diagnosis
- HbA1c (DCCT-standard) must be ≥ 9.0% and ≤12%
- Insulin resistance defined as required daily dose up to 1.5u/kg or a maximum of 200 units insulin per day
- Aged 20 to 75 years old inclusive
- On premixed regimen (human or analogue insulin) defined as ≥ 2 injections per day for at least 3 months prior signing the informed consent
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- Ability to comply with technology, according to Investigator's judgment
- Patients must be willing to undergo all study procedures
- Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator
- CRITERIA FOR INCLUSION AT RANDOMISATION
- Diagnosed with type 2 DM, as per Investigator diagnosis
- HbA1c (DCCT-standard) must be ≥ 9.0% and ≤12%
- Insulin resistance defined as required daily dose up to 1.5 U/Kg or a maximum of 200 units per day
- On premixed regimen (human or analogue insulin) defined as ≥ 2 injections per day for at least 3 months prior signing the informed consent
- Ability to comply with technology, according to Investigator's judgment
- ≥ 2.5 SMBG per day on average
- Patients must be willing to undergo all study procedures
- Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator
Who cannot join
- CRITERIA FOR EXCLUSION (AT SCREENING AND RANDOMISATION)
- Subject has a history (≥ 2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months
- Subject is pregnant as assessed by a pregnancy test with central laboratory, or plans to become pregnant during the course of the study
- Participation in another interventional clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
- Subject has proliferative retinopathy or sight threatening maculopathy
- Subject has
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- an acute coronary syndrome (myocardial infarction or unstable angina) within 12 months OR
- coronary artery revascularization by bypass surgery or stenting within 3 months OR
- a transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 3 months OR
- hospitalization for heart failure within 3 months or current New York Functional Class III or IV OR
- current 2nd or 3rd degree heart block OR
- symptomatic ventricular rhythm disturbances OR
- thromboembolic disease within the last 3 months OR
- Subject with renal impairment expressed as estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula < 30 ml/min as demonstrated by the screening central laboratory value at the time of enrollment
- Subject has taken oral or injectable steroids within the last 30 days.
- Systolic blood pressure on screening visit is > 180 mmHg
- Diastolic blood pressure on screening visit is > 110 mmHg
- Any other disease (eg active cancer under treatment) or condition including abnormalities found on the screening tests, that in the opinion of the Investigator, may preclude the patient from participating in the study
- Taking any medication prescribed for weight loss
- Alcohol or drug abuse, other than nicotine, at the Investigator's discretion Use of a Glucagon Like Peptide-1 agonist or pramlintide (Symlin®). Glucagon Like Peptide-1 slows gastric emptying, thereby decreasing the rate of glucose absorption. Pramlintide (Symlin®) is a commercially available analogue of amylin, a synergistic partner to insulin.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Putrajaya
Putrajaya, Kuala Lumpur, 62250
Zanariah Hussein, MBBS,MRCP, 0122907136, ppzana@hpj.gov.my
Nurain Mohd Noor, MBBS,MMed, 0122051570, ppnurain@hpj.gov.my
About this study
The purpose of this study is to evaluate the comparative efficacy of insulin pump therapy versus multiple daily injections in insulin-taking type 2 diabetes mellitus who are sub-optimally controlled with premixed insulin regimen. This research is necessary because many patients with type 2 diabetes mellitus do not meet their glucose targets.
In advanced Type 2 diabetes mellitus, many patients develop worsening diabetes control and unable to reach the glucose targets despite intensive insulin regimens.This is further complicated by the risks of low blood sugar and weight gain. These limitations of multiple daily injection treatment show the need for new treatments for this group of patients.
Read the detailed description
This study evaluates between group change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 Diabetes Mellitus, as compared to patients on multiple daily injections (MDI) therapy over the same time period. It also evaluates between group changes in diabetes clinical outcomes after 6 months in patients with type 2 DM. Patient related outcomes will be measured after 6 months of therapy. The primary endpoint will be between group difference in average HbA1c changes from baseline to 6 months, when comparing Continuous Subcutaneous Insulin Infusion (CSII) to MDI.
The secondary end point concerns the safety issues such as severe hypoglycemia incidence: defined as an episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory blood glucose by finger stick of less than 50mg/dL (2.8 mmol/L), (i.e., subject is unable to treat self and requires carbohydrate, glucagon or other resuscitative actions to prevent further clinical deterioration), hospitalizations, Diabetic Ketoacidosis (DKA), an acute metabolic complication of diabetes, characterized by hyperglycemia, hyperketonemia, and metabolic acidosis, within group difference in HbA1c from 6 months to 12 months, change in weight or BMI, change in Lipids : total cholesterol, high density lipoprotein(HDL),low density lipoprotein(LDL),triglyceride, change in blood pressure, Insulin Dosage Changes (Total Daily Dose), Number of self monitoring blood glucose (SMBG)/day, treatment satisfaction: Diabetes Treatment Satisfaction Questionnaire status and change version (DTSQs and DTSQc).
The hypotheses underlying the secondary outcomes : the pump therapy improves glycaemic control whilst utilizing less total daily dose of insulin in comparison to multiple daily injections of insulin. This is associated with parallel improvement in metabolic profiles such as blood pressure and lipids. As for the glucose monitoring, investigators want to evaluate whether there is any difference in the frequency of SMBG/day between the 2 treatment groups. More frequent SMBG monitoring denotes better compliance, motivation and empowerment by the participants to control their diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin Pump, Multiple daily injections of insulin
- Keywords
- insulin pump, basal bolus insulin
- 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.
Insulin PumpDevice
Medtronic Minimed Paradigm Veo Insulin Pump
Multiple daily injections of insulinDrug
Also called Basal bolus injections of insulin
Multiple daily injections which consist of a single injection of basal insulin(insulin Glargine) and 3 injections of bolus insulin(rapid acting insulin Glulisine or Aspart) before each meal
| Study group | Role | What they receive |
|---|---|---|
| Insulin pump | Active comparator | Medtronic Minimed Paradigm Veo Insulin Pump utilising rapid acting insulin Glulisine or Aspart Receives: Device: Insulin Pump; Drug: Multiple daily injections of insulin |
| Multiple daily injections of insulin | Active comparator | Multiple daily injections consisting of a single basal insulin injection(Glargine) and 3 bolus insulin injections (rapid acting insulin Glulisine or Aspart) before each meal Receives: Device: Insulin Pump; Drug: Multiple daily injections of insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
between group difference of HbA1c changes from baseline to 6 months
Between group difference in HbA1c changes from baseline to 6 months, when comparing CSII to MDI
Measured: 6 months
Secondary outcomes (8)
Within group difference in HbA1c changes from 6 months to 12 months
Within group difference in HbA1c changes from 6 months to 12 months after cross-over from MDI to CSII
Measured: 1 year
Safety endpoints which are 1) Number of events of severe hypoglycemia 2)Any hospitalizations for hypoglycaemia or hyperglycaemic emergencies 3)Number of events of Diabetic Ketoacidosis (DKA)
- Number of events of severe hypoglycemia : defined as an episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory blood glucose by finger stick of less than 50mg/dL (2.8 mmol/L), (i.e., subject is unable to treat self and requires carbohydrate, glucagon or other resuscitative actions to prevent further clinical deterioration)
- Any hospitalizations for hypoglycaemia or hyperglycaemic emergencies
- Number of events of Diabetic Ketoacidosis (DKA), an acute metabolic complication of diabetes, characterized by hyperglycemia, hyperketonemia, and metabolic acidosis
Measured: 1 year
change in weight (kg)
Between and within group difference in average weight changes when comparing CSII to MDI
Measured: 1 year
Number of Self Monitoring Blood Glucose (SMBG) per day
Between and within group difference in the number of SMBG per day between CSII and MDI. The data is downloaded using Bayer Glucofacts Deluxe Software from the glucometer during each visit.
Measured: 1 year
Total Daily Insulin Dosage per day in Unit/day
Between and within group total daily insulin dosage per day in Unit/day between CSII and MDI. The total daily insulin dose per day in the CSII group is downloaded from Medtronic CareLink Therapy Management Software whereas for the MDI group, it is the cumulative dosage of total insulin per day.
Measured: 1 year
Total Daily Insulin Dosage per body weight in kilograms per day (Unit/kg/day)
Between and within group total daily insulin dosage per day (Outcome 6) divide by body weight in kilograms (Outcome 8) measured as (Unit/kg/day) for each patient,comparing between CSII and MDI
Measured: 1 year
Body weight in kilograms
Between and within group body weight in kilograms, comparing between CSII and MDI
Measured: 1 year
Treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire DTSQs
Treatment satisfaction: Diabetes Treatment Satisfaction Questionnaire using DTSQs comparing between CSII and MDI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Nurain Mohd Noor, Clinical Research Centre, Malaysia
- Investigators
- Noor Rafhati Adyani NR Abdullah, MBBS,MRCP, Principal investigator, Putrajaya Hospital, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112538
- Sponsor's protocol ID
- NERP14-019
- Status last verified
- Apr 2017
- First submitted
- 12 Oct 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Glycaemic Control in Malaysian Patients With Type 2 Diabetes Mellitus With Insulin Pump Therapy
- ClinicalTrials.gov ID
- NCT03112538
- Acronym / sponsor ID
- NERP14-019
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- insulin pump, basal bolus insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Apr 2017 (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 evaluate the comparative efficacy of insulin pump therapy versus multiple daily injections in insulin-taking type 2 diabetes mellitus who are sub-optimally controlled with premixed insulin regimen. This research is necessary because many patients with type 2 diabetes mellitus do not meet their glucose targets.
In advanced Type 2 diabetes mellitus, many patients develop worsening diabetes control and unable to reach the glucose targets despite intensive insulin regimens.This is further complicated by the risks of low blood sugar and weight gain. These limitations of multiple daily injection treatment show the need for new treatments for this group of patients.
Detailed description
This study evaluates between group change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 Diabetes Mellitus, as compared to patients on multiple daily injections (MDI) therapy over the same time period. It also evaluates between group changes in diabetes clinical outcomes after 6 months in patients with type 2 DM. Patient related outcomes will be measured after 6 months of therapy. The primary endpoint will be between group difference in average HbA1c changes from baseline to 6 months, when comparing Continuous Subcutaneous Insulin Infusion (CSII) to MDI.
The secondary end point concerns the safety issues such as severe hypoglycemia incidence: defined as an episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory blood glucose by finger stick of less than 50mg/dL (2.8 mmol/L), (i.e., subject is unable to treat self and requires carbohydrate, glucagon or other resuscitative actions to prevent further clinical deterioration), hospitalizations, Diabetic Ketoacidosis (DKA), an acute metabolic complication of diabetes, characterized by hyperglycemia, hyperketonemia, and metabolic acidosis, within group difference in HbA1c from 6 months to 12 months, change in weight or BMI, change in Lipids : total cholesterol, high density lipoprotein(HDL),low density lipoprotein(LDL),triglyceride, change in blood pressure, Insulin Dosage Changes (Total Daily Dose), Number of self monitoring blood glucose (SMBG)/day, treatment satisfaction: Diabetes Treatment Satisfaction Questionnaire status and change version (DTSQs and DTSQc).
The hypotheses underlying the secondary outcomes : the pump therapy improves glycaemic control whilst utilizing less total daily dose of insulin in comparison to multiple daily injections of insulin. This is associated with parallel improvement in metabolic profiles such as blood pressure and lipids. As for the glucose monitoring, investigators want to evaluate whether there is any difference in the frequency of SMBG/day between the 2 treatment groups. More frequent SMBG monitoring denotes better compliance, motivation and empowerment by the participants to control their diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin pump | Active comparator | Device: Insulin Pump, Drug: Multiple daily injections of insulinMedtronic Minimed Paradigm Veo Insulin Pump utilising rapid acting insulin Glulisine or Aspart |
| Multiple daily injections of insulin | Active comparator | Device: Insulin Pump, Drug: Multiple daily injections of insulinMultiple daily injections consisting of a single basal insulin injection(Glargine) and 3 bolus insulin injections (rapid acting insulin Glulisine or Aspart) before each meal |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- CRITERIA FOR INCLUSION AT SCREENING
- Diagnosed with type 2 Diabetes Mellitus, as per Investigator diagnosis
- HbA1c (DCCT-standard) must be ≥ 9.0% and ≤12%
- Insulin resistance defined as required daily dose up to 1.5u/kg or a maximum of 200 units insulin per day
- Aged 20 to 75 years old inclusive
Key exclusion criteria (20 listed)
- CRITERIA FOR EXCLUSION (AT SCREENING AND RANDOMISATION)
- Subject has a history (≥ 2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months
- Subject is pregnant as assessed by a pregnancy test with central laboratory, or plans to become pregnant during the course of the study
- Participation in another interventional clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
- Subject has proliferative retinopathy or sight threatening maculopathy
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 |
|---|---|---|
| Insulin PumpMedtronic Minimed Paradigm Veo Insulin Pump | Device | Insulin pump, Multiple daily injections of insulin |
| Multiple daily injections of insulinAlso: Basal bolus injections of insulinMultiple daily injections which consist of a single injection of basal insulin(insulin Glargine) and 3 injections of bolus insulin(rapid acting insulin Glulisine or Aspart) before each meal | Drug | Insulin pump, Multiple daily injections of insulin |
Primary outcome
between group difference of HbA1c changes from baseline to 6 months
Time frame: 6 months
Between group difference in HbA1c changes from baseline to 6 months, when comparing CSII to MDI
8 secondary outcomes
Within group difference in HbA1c changes from 6 months to 12 months
Time frame: 1 year
Safety endpoints which are 1) Number of events of severe hypoglycemia 2)Any hospitalizations for hypoglycaemia or hyperglycaemic emergencies 3)Number of events of Diabetic Ketoacidosis (DKA)
Time frame: 1 year
change in weight (kg)
Time frame: 1 year
Number of Self Monitoring Blood Glucose (SMBG) per day
Time frame: 1 year
Total Daily Insulin Dosage per day in Unit/day
Time frame: 1 year
Total Daily Insulin Dosage per body weight in kilograms per day (Unit/kg/day)
Time frame: 1 year
Body weight in kilograms
Time frame: 1 year
Treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire DTSQs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- 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.
Noor Rafhati Adyani NR Abdullah, MBBS,MRCP principal investigator
Putrajaya Hospital, Malaysia
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 Insulin Pump and Multiple daily injections of insulin in people with Type 2 Diabetes Mellitus, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
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 18 inclusion and 20 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 13 Apr 2017. 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 Malaysia. 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 Noor Rafhati Adyani NR Abdullah, MBBS,MRCP (+60174675921, adyania@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
between group difference of HbA1c changes from baseline to 6 months (time frame: 6 months). 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 13 Apr 2017.