Overview

Comparison of Thrice-Daily Premixed Human Insulin with Basal-Bolus Therapy Among Patients with Poorly Controlled Type 2 Diabetes Mellitus

Status:
COMPLETED

Trial end date:
2021-07-01

Target enrollment:

Participant gender:

Summary

The goal of this cross-over study is to learn if thrice-daily (TDS) premixed human insulin (PHI) is as useful as basal-bolus (BB) therapy as an intensification treatment in people with poorly controlled type 2 diabetes mellitus (T2DM). The main questions it aims to answer are: * To determine the efficacy of TDS PHI compared to BB insulin regimen by measuring HbA1c changes over 12 weeks. * To determine the changes in fasting plasma glucose (FPG), the total daily dose (TDD) of insulin, weight changes, and hypoglycaemia rate, and to study the adherence rate to insulin injection between the two regimens over 12 weeks. Researchers will compare TDS-PHI to BB regimen to see if the glycemic control, TDD of insulin, weight gain, hypoglycemia and adherence rate are the same. Participants will: * take TDS-PHI or BB for 12 weeks and cross over to the other regimen for another 12 weeks * visit the clinic once every 4 weeks for checkups and tests * keep a diary of their self-monitoring of blood glucose (SMBG), insulin doses, hypoglycaemic symptoms and blood glucose readings, and the number of times they miss insulin injections.

Phase:

PHASE4

Details

Lead Sponsor:

Hospital Sultanah Aminah Johor Bahru

Collaborator:

Penang Hospital, Malaysia