Comparison of Insulin Glargine and Regular Insulin Versus NPH and Regular Insulin in the Treatment of T1DM

January 29, 2023 updated by: King Edward Medical University

Comparison of Insulin Glargine Mixed With Regular Insulin Versus the Standard Neutral Protamine Hagedorn (NPH) and Regular Insulin in the Treatment of Type 1 Diabetes Mellitus

To compare the glycemic control in children with type 1 diabetes using insulin Glargine and regular insulin as basal bolus therapy versus Neutral Protamine Hagedorn insulin (NPH) and regular insulin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diagnosed patients with Type-1 diabetes mellitus (T1DM), who had been on insulin therapy for more than three months, and met the eligibility criteria, were enrolled and randomly divided into group A and group B using the lottery method performed by the nursing staff.

Baseline HbA1c level was done for all the patients using CERA-STAT 2000 analyzer. The funding from KEMU was used to arrange insulin glargine and glucometer strips. The blood glucose levels of the patients were measured using the glucometer Freestyle Optium Neo H (manufactured by Abbott). Patients and their guardians were taught how to use the glucometer and record the measurements on monitoring sheets.

The total daily insulin dose was calculated according to the patient's age and pubertal stage for both groups. Patients in Group A (glargine-regular regimen) received insulin glargine (GLA) once in the evening (8:00 pm) and regular insulin 30 minutes before their three main meals. The starting dose of the GLA was 30% of the total daily insulin dose and titrated by 5-10 % according to the self-monitored fasting blood glucose levels to meet the age-appropriate goal range and avoid nocturnal hypoglycemia.

Patients in Group B (NPH-regular regimen) continued receiving NPH with regular insulin twice daily using the split and mix method, 30 minutes before breakfast and before dinner. NPH comprised 70% of the total daily dose. NPH titration was similar to that of the GLA group.

Each patient measured their capillary blood glucose levels 4-6 times per day as follows: pre-breakfast and 2-hours after breakfast, pre-lunch and 2-hours after lunch, pre-dinner and 2-hours after dinner. This monitoring continued for 90 days of the trial period.

Mid-night glucose levels were checked once weekly between 12 am and 3 am to check for hypolycemia or hyperglycemia, and that gave us 12 readings for the 90 days trial.

Each monitoring sheet presented the readings of pre-meals and 2-hours-post meals capillary blood glucose levels for each patient for 30 days. (annexure-B) All patients were followed up fortnightly at the Pediatric endocrine and diabetes section, Pediatric department, Mayo Hospital. Patients' compliance, insulin administration, and storage were assessed on each visit by asking the patient and the guardian. If needed, they were taught by the doctor and nurse attending the clinic. Both groups were instructed to walk daily for 20- 30 minutes and have three main meals and three snacks with avoidance of high carbohydrate dietary items. The patients had to mark their compliance with the instructed exercise and diet plan in the monitoring sheets.

The monitoring sheets were collected monthly during the study trial. After 90 days of the study, their HbA1C levels were tested using the same analyzer mentioned above for the baseline HbA1c.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Pediatric endocrine and diabetes section, Pediatric department, Mayo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children of age 3 to 18 years with Type 1 Diabetes Mellitus

Exclusion Criteria:

  • Children below or above 18 years
  • Comorbidities like celiac disease, hypothyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glargine
Glargine-regular insulin regimen
Drug: Glargine and regular insulin versus NPH and regular insulin

Patients with type 1 diabetes (T1DM) in group A received insulin glargine as basal therapy at night and regular insulin given prior to each main meal.

Patients in group B were given NPH and regular insulin in split and mix method in the morning and evening.
ACTIVE_COMPARATOR: NPH
NPH- regular insulin regimen
Drug: Glargine and regular insulin versus NPH and regular insulin

Patients with type 1 diabetes (T1DM) in group A received insulin glargine as basal therapy at night and regular insulin given prior to each main meal.

Patients in group B were given NPH and regular insulin in split and mix method in the morning and evening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Three months
Baseline HbA1c is compared with the end HbA1c after 3 months of therapy
Three months
Hypoglycemia
Time Frame: Three months
Capillary blood sugar level below 70mg/dl
Three months
Fasting blood sugar
Time Frame: Three months
Capillary blood sugar before breakfast
Three months
Post-meal blood
Time Frame: Three months
Capillary blood sugar level 2 hours after the three main meals
Three months
Mid night blood glucose level
Time Frame: Three months
Capillary blood glucose levels between 12:00am -3:00am
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ACTUAL)

January 5, 2021

Study Completion (ACTUAL)

April 20, 2021

Study Registration Dates

First Submitted

January 14, 2023

First Submitted That Met QC Criteria

January 29, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Glargine and regular insulin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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