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Difference of Basal Insulin Titration Method in Reducing HbA1c Among Type 2 Diabetes Mellitus (T2DM) Patients.

NCT05331469 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-04-15

No results posted yet for this study

Summary

Introduction Diabetes mellitus is a worrying global non-communicable disease where it is affecting 18.3% of Malaysian adults. Poorly managed diabetes leads to an array of serious complications, namely heart attack, kidney failure and stroke. Insulin therapy remains one of the most important medication in treating diabetes especially in the population with high sugar readings or long standing diabetes. Outpatient consultations for T2DM patients are spaced out due to the limited amount of treating physicians and clinic time. This resorts to the importance of outpatient patient-lead insulin titration. Different guidelines from local and international showed different basal insulin titration method in achieving ideal fasting blood sugar.

Objective We aim to investigate the difference of basal insulin titration methods in reducing HbA1c among the T2DM patients.

Methodology In a parallel group randomized controlled trial, we aim to recruit 70 adult T2DM patients who have poorly controlled T2DM ( HbA1c \> 7.5% with FPG \>8mmol/L) or newly diagnosed T2DM patients (who are symptomatic or HbA1c \>10% or FPG \>13 mmol/L). The subjects will be randomized to 2 groups, daily basal insulin titration and 3 daily basal insulin titration. These subjects will be follow up for 12 weeks (4th week and 8th week virtual consultation and 12th week face-to-face consultation). The primary outcome is the HbA1c reduction from baseline to the end of 12weeks intervention. The secondary outcomes are percentage of T2DM patients achieving fasting blood sugar within 4.4-7mmol/L and/or HbA1c \<7% within the study period, the incidence of hypoglycemia, total daily basal insulin dosage required to achieve desired fasting blood sugar, duration taken to achieve desired fasting blood sugar, weight changes and satisfaction to the therapy between the 2 intervention groups.

Clinical Significance This study enables us to evaluate the efficacy of the different basal insulin titration methods among the T2DM patients.

Conditions

  • to Identify Which Titration Regimen of Basal Insulin (Being Daily Titration vs 3 Daily Titration) is Better in Reducing hba1c and Have Lesser Hypoglycemia

Interventions

DRUG

NPH basal insulin titration

Comparing both arms NPH basal insulin titration in reducing hba1c after 3 months

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Yi Jiang Chua · Universiti Malaya Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2022-08-31
Completion
2023-04-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05331469 on ClinicalTrials.gov