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

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ClinicalTrials.gov Identifier: NCT05709938
Recruitment Status : Completed
First Posted : February 2, 2023
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
King Edward Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
To Assess the Glycemic Control of Insulin Glargine in Combination With Regular Insulin in Type 1 Diabetes in Children Drug: Glargine and regular insulin versus NPH and regular insulin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 34 in each Arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : January 5, 2021
Actual Study Completion Date : April 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.





Primary Outcome Measures :
  1. HbA1c [ Time Frame: Three months ]
    Baseline HbA1c is compared with the end HbA1c after 3 months of therapy

  2. Hypoglycemia [ Time Frame: Three months ]
    Capillary blood sugar level below 70mg/dl

  3. Fasting blood sugar [ Time Frame: Three months ]
    Capillary blood sugar before breakfast

  4. Post-meal blood [ Time Frame: Three months ]
    Capillary blood sugar level 2 hours after the three main meals

  5. Mid night blood glucose level [ Time Frame: Three months ]
    Capillary blood glucose levels between 12:00am -3:00am



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT05709938


Locations
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Pakistan
Pediatric endocrine and diabetes section, Pediatric department, Mayo Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
King Edward Medical University
Publications:
1. Kliegman R, Stanton B, Geme J, Schor, Behrman R editor. Nelson textbook of pediatrics.20th ed. Canada: Elsevier; 2015.2763-2783.
Cryer P. Hypoglycemia in diabetes: pathophysiology, prevalence, and prevention. American Diabetes Association; 2016 Jul 12.

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Responsible Party: King Edward Medical University
ClinicalTrials.gov Identifier: NCT05709938    
Other Study ID Numbers: Glargine and regular insulin
First Posted: February 2, 2023    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs