NCT03112538

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2016

Typical duration for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

October 12, 2016

Last Update Submit

April 9, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

insulin pumpbasal bolus insulin

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (8)

  • Within group difference in HbA1c changes from 6 months to 12 months

    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)

    1 year

  • change in weight (kg)

    1 year

  • Number of Self Monitoring Blood Glucose (SMBG) per day

    1 year

  • Total Daily Insulin Dosage per day in Unit/day

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Insulin pump

ACTIVE COMPARATOR

Medtronic Minimed Paradigm Veo Insulin Pump utilising rapid acting insulin Glulisine or Aspart

Device: Insulin PumpDrug: 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

Device: Insulin PumpDrug: Multiple daily injections of insulin

Interventions

Insulin PumpDEVICE

Medtronic Minimed Paradigm Veo Insulin Pump

Insulin pumpMultiple daily injections of insulin
Multiple daily injections of insulinDRUG

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

Also known as: Basal bolus injections of insulin
Insulin pumpMultiple daily injections of insulin

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Putrajaya

Putrajaya, Kuala Lumpur, 62250, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical Equipment

Study Officials

  • Noor Rafhati Adyani NR Abdullah, MBBS,MRCP

    Putrajaya Hospital, Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noor Rafhati Adyani NR Abdullah, MBBS,MRCP

CONTACT

+60174675921adyania@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Endocrinologist

Study Record Dates

First Submitted

October 12, 2016

First Posted

April 13, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)