Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in Diabetic Tunisian Patients.

NCT06999551 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: GRANT2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will have a single arm: the patient on NPH will continue his treatment for 4 weeks, at the end of the NPH treatment, the patient will receive his CGM device for three days for glycemic holter, a switch to insulin glargine is started for a period of 12 weeks with a dose adjustment and a control of the glycemic balance by CGM for three days at the end of the study. The NPH insulin vial is a 10 ml vial dosed at 100 IU/mL, The Glargen vial is in the form of a solution for injection, a 3 ml vial dosed at 100 IU/mL

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus; NPH; Insulin glargin; continuous glucose monitoring; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• glycaemic variability on insulin glargine (after 12 weeks of use) versus NPH insulin (baseline)

  compare glycaemic variability on insulin glargine (after 12 weeks of use) versus NPH insulin (baseline) using the CGM device generating the area under the curve in the range, above the range, below the range in type 2 diabetic patients treated with NPH basal insulin alone or in combination with oral antidiabetic drugs.

  4 months

Study Arms (1)

patient receiving NPH insulin

EXPERIMENTAL

evaluating safety and efficacy after switching the patient receiving NPH into glargin insulin.

Drug: switch NPH to glargin

Interventions

switch NPH to glargin DRUG

Switch of patients with type 2 diabetes mellitus from NPH insulin to insulin glargine

patient receiving NPH insulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 18 and \<70
• Type 2 diabetic patients, with a duration of NPH between 5 and 10 years.
• Patients treated with a double dose of NPH insulin with a stable dose of insulin and a stable dose of ADO (oral antidiabetic drugs) for at least 2 months prior to the start of the study.
• An HbA1c level between 7% and 10%
• Ability to use a continuous glucose monitoring (CGM) system and cycle blood glucose with the meter.
• Written informed consent obtained prior to participation in the study.

You may not qualify if:

• Pregnant and breastfeeding women
• History of insulin glargine hypersensitivity
• Treatment with systemic, neuroleptic, immunosuppressive and antiretroviral corticosteroids within 3 months prior to study entry and during the study and other treatments, which may significantly affect blood glucose.
• Severe renal impairment at baseline defined by a \< 30ml/min.
• Patients on sulfonylurea drugs or glinides or on more than three oral antidiabetic drugs (ODAs)
• Patients on rapid insulin.
• Patients Enrolled in Other Clinical Studies
• Patients who refuse to sign consent.

Sponsors & Collaborators

• Les Laboratoires des Médicaments Stériles: lead

Study Sites (1)

Hedi Chaker Hospital

Sfax, 3000, Tunisia

Location

Related Publications (3)

• Cohen MP, Shea E, Chen S, Shearman CW. Glycated albumin increases oxidative stress, activates NF-kappa B and extracellular signal-regulated kinase (ERK), and stimulates ERK-dependent transforming growth factor-beta 1 production in macrophage RAW cells. J Lab Clin Med. 2003 Apr;141(4):242-9. doi: 10.1067/mlc.2003.27.

  PMID: 12677169 RESULT

• Danielsson P, Truedsson L, Eriksson KF, Norgren L. Inflammatory markers and IL-6 polymorphism in peripheral arterial disease with and without diabetes mellitus. Vasc Med. 2005 Aug;10(3):191-8. doi: 10.1191/1358863x05vm617oa.

  PMID: 16235772 RESULT

• Hirsch IB, Brownlee M. Should minimal blood glucose variability become the gold standard of glycemic control? J Diabetes Complications. 2005 May-Jun;19(3):178-81. doi: 10.1016/j.jdiacomp.2004.10.001.

  PMID: 15866065 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nabila Rekik, Professor

  STEDIAM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabila Rekik, Professor

CONTACT

98609300; nabila.rekik.mejdoub@gmail.com

Ibtissem Ben naceuf, Professor

CONTACT

22544 395; bennacef.ibtissem@yahoo.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: May 31, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

TU (1)