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Not yet recruitingNCT06999551GRANTUpdated May 31, 2025

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

A Phase 4 interventional study of switch NPH to glargin in Diabetes Mellitus, sponsored by Les Laboratoires des Médicaments Stériles. Not yet recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Les Laboratoires des Médicaments Stériles · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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

Read the detailed description

Follow-up visits will include :

  • V0: - 4 weeks: Screening visit (before the start of treatment): patients will be selected at this initial visit, if they meet all the inclusion criteria and none of the non-inclusion criteria, the patient will receive the glucometer. The patient presents himself to do his initial assessment (including HbA1c) and sign the consent, to do his therapeutic education and to receive the nutrition booklet
  • V1: -3 weeks: the patient will be contacted by the ARC (phone call) to communicate the results of the glycemic cycle already performed and for titration of his NPH, continue with the new dose until the monitoring stops
  • V2: inclusion visit: D0: 4 weeks later, the patient will receive his CGM. A glycemic cycle will be done and communicated to the ARC.
  • V3: Visit of 4 weeks + 07 days: the day the patient presents himself to put the CGM device back on (stop monitoring) and collect data (glycemic holter under NPH) and switch to insulin glargine.
  • V4 + V5: respectively at 2 and 3 weeks after switching to insulin glargine, the CRA contacts the patient by phone to record the results of the glycemic cycle and thus adapt the dose of insulin glargine upwards or downwards as needed (titration). The patient will do a glycemic cycle and communicate it to their ARC. Continue with the new dose until the next V6 titration
  • V6: at 6 weeks after switching to insulin glargine, the patient will attend the consultation (face-to-face) to communicate the results of the corresponding glycemic cycle and thus adapt the dose of insulin glargine upwards or downwards as needed (titration). Continue with the new dose until monitoring is stopped
  • V7: 12 weeks after starting glargine, the patient presents again for placement of the CGM device (start of monitoring). The patient will also do a glycemic cycle at the same time and communicate it to his ARC. A laboratory assessment (including glycated hemoglobin) will be requested.
  • V8: 12 weeks + 7 days stop CGM monitoring (collection of holter results under glargine) and end of the study.
02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • diabetes mellitus
  • NPH
  • Insulin glargin
  • continuous glucose monitoring
  • efficacy
  • safety
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Les Laboratoires des Médicaments Stériles is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Pregnant and breastfeeding women
  • Patients with active proliferative and/or complicated diabetic retinopathy, treated by photocoagulation or surgically, within 6 months prior to study entry or any other rapidly progressing unstable retinopathy that may require photocoagulation or surgery during the study (plan to perform fundus prior to inclusion).
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    patient receiving NPH insulin

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

    Drug: switch NPH to glargin

Interventions

  • Drugswitch NPH to glargin

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

06

What researchers measure

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.

    Time frame: 4 months

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 12677169 ↗
  • 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. PubMed 16235772 ↗
  • 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. PubMed 15866065 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06999551
Lead sponsor
Les Laboratoires des Médicaments Stériles
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 31, 2025

Study contacts

Nabila Rekik, Professor
Contact
nabila.rekik.mejdoub@gmail.com
98609300 ext. +216
Ibtissem Ben naceuf, Professor
Contact
bennacef.ibtissem@yahoo.fr
22544 395 ext. +216
Nabila Rekik, Professor
principal investigator · STEDIAM

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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