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Improving Glycaemic Control in Malaysian Patients With Type 2 Diabetes Mellitus With Insulin Pump Therapy

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ClinicalTrials.gov Identifier: NCT03112538
Recruitment Status : Unknown
Verified April 2017 by Nurain Mohd Noor, Clinical Research Centre, Malaysia.
Recruitment status was:  Recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Nurain Mohd Noor, Clinical Research Centre, Malaysia

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Device: Insulin Pump Drug: Multiple daily injections of insulin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Glycaemic Control in Malaysian Patients With Type 2 Diabetes Mellitus With Insulin Pump Therapy
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Insulin pump
Medtronic Minimed Paradigm Veo Insulin Pump utilising rapid acting insulin Glulisine or Aspart
Device: Insulin Pump
Medtronic Minimed Paradigm Veo Insulin Pump

Drug: Multiple daily 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
Other Name: Basal bolus injections of insulin

Active Comparator: Multiple daily injections of insulin
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
Device: Insulin Pump
Medtronic Minimed Paradigm Veo Insulin Pump

Drug: Multiple daily 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
Other Name: Basal bolus injections of insulin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Within group difference in HbA1c changes from 6 months to 12 months [ Time Frame: 1 year ]
    Within group difference in HbA1c changes from 6 months to 12 months after cross-over from MDI to CSII

  2. 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 ]
    1. 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)
    2. Any hospitalizations for hypoglycaemia or hyperglycaemic emergencies
    3. Number of events of Diabetic Ketoacidosis (DKA), an acute metabolic complication of diabetes, characterized by hyperglycemia, hyperketonemia, and metabolic acidosis

  3. change in weight (kg) [ Time Frame: 1 year ]
    Between and within group difference in average weight changes when comparing CSII to MDI

  4. Number of Self Monitoring Blood Glucose (SMBG) per day [ Time Frame: 1 year ]
    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.

  5. Total Daily Insulin Dosage per day in Unit/day [ Time Frame: 1 year ]
    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.

  6. Total Daily Insulin Dosage per body weight in kilograms per day (Unit/kg/day) [ Time Frame: 1 year ]
    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

  7. Body weight in kilograms [ Time Frame: 1 year ]
    Between and within group body weight in kilograms, comparing between CSII and MDI

  8. Treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire DTSQs [ Time Frame: 1 year ]
    Treatment satisfaction: Diabetes Treatment Satisfaction Questionnaire using DTSQs comparing between CSII and MDI



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

CRITERIA FOR INCLUSION AT SCREENING

  1. Diagnosed with type 2 Diabetes Mellitus, as per Investigator diagnosis
  2. HbA1c (DCCT-standard) must be ≥ 9.0% and ≤12%
  3. Insulin resistance defined as required daily dose up to 1.5u/kg or a maximum of 200 units insulin per day
  4. Aged 20 to 75 years old inclusive
  5. On premixed regimen (human or analogue insulin) defined as ≥ 2 injections per day for at least 3 months prior signing the informed consent
  6. Ability to comply with technology, according to Investigator's judgment
  7. Patients must be willing to undergo all study procedures
  8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator

CRITERIA FOR INCLUSION AT RANDOMISATION

  1. Diagnosed with type 2 DM, as per Investigator diagnosis
  2. HbA1c (DCCT-standard) must be ≥ 9.0% and ≤12%
  3. Insulin resistance defined as required daily dose up to 1.5 U/Kg or a maximum of 200 units per day
  4. On premixed regimen (human or analogue insulin) defined as ≥ 2 injections per day for at least 3 months prior signing the informed consent
  5. Ability to comply with technology, according to Investigator's judgment
  6. ≥ 2.5 SMBG per day on average
  7. Patients must be willing to undergo all study procedures
  8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator

Exclusion Criteria:

CRITERIA FOR EXCLUSION (AT SCREENING AND RANDOMISATION)

  1. Subject has a history (≥ 2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months
  2. Subject is pregnant as assessed by a pregnancy test with central laboratory, or plans to become pregnant during the course of the study
  3. Participation in another interventional clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
  4. Subject has proliferative retinopathy or sight threatening maculopathy
  5. Subject has

    • 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
  6. 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
  7. Subject has taken oral or injectable steroids within the last 30 days.
  8. Systolic blood pressure on screening visit is > 180 mmHg
  9. Diastolic blood pressure on screening visit is > 110 mmHg
  10. 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
  11. Taking any medication prescribed for weight loss
  12. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112538


Contacts
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Contact: Noor Rafhati Adyani NR Abdullah, MBBS,MRCP +60174675921 adyania@yahoo.com

Locations
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Malaysia
Hospital Putrajaya Recruiting
Putrajaya, Wilayah Persekutuan, Malaysia, 62250
Contact: Zanariah Hussein, MBBS,MRCP    0122907136    ppzana@hpj.gov.my   
Contact: Nurain Mohd Noor, MBBS,MMed    0122051570    ppnurain@hpj.gov.my   
Principal Investigator: Noor Rafhati Adyani Abdullah, MBBS,MRCP         
Sponsors and Collaborators
Clinical Research Centre, Malaysia
Medtronic
Investigators
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Principal Investigator: Noor Rafhati Adyani NR Abdullah, MBBS,MRCP Putrajaya Hospital, Malaysia

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Responsible Party: Nurain Mohd Noor, Consultant Endocrinologist, Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier: NCT03112538     History of Changes
Other Study ID Numbers: NERP14-019
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nurain Mohd Noor, Clinical Research Centre, Malaysia:
insulin pump
basal bolus insulin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin glulisine
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs