Diabetes MellitusPhase 4GRANTNCT06999551
Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in Diabetic Tunisian Patients.
A Phase 4 study testing switch NPH to glargin in people with Diabetes Mellitus, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- switch NPH to glargin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jul 2025to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- Patients on rapid insulin.
- Patients Enrolled in Other Clinical Studies
- Patients who refuse to sign consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
Hedi Chaker Hospital
Sfax, 3000
Nabila Rekik, Professor, +216 98 609 300, nabila.rekik.mejdoub@gmail.com
About this study
Official title: Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in the Treatment of Diabetes Type 2, in Tunisian Patients.
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.
- Conditions
- Diabetes Mellitus
- Being tested
- switch NPH to glargin
- Keywords
- diabetes mellitus, NPH, Insulin glargin, continuous glucose monitoring, efficacy, safety
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
switch NPH to glarginDrug
Switch of patients with type 2 diabetes mellitus from NPH insulin to insulin glargine
| Study group | Role | What they receive |
|---|---|---|
| patient receiving NPH insulin | Experimental | evaluating safety and efficacy after switching the patient receiving NPH into glargin insulin. Receives: Drug: switch NPH to glargin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nabila Rekik, Professor, Principal investigator, STEDIAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999551
- Sponsor's protocol ID
- GRANT2025
- Acronym
- GRANT
- Status last verified
- May 2025
- First submitted
- 7 Mar 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 12677169Danielsson 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 16235772Hirsch 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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in the Treatment of Diabetes Type 2, in Tunisian Patients.
- ClinicalTrials.gov ID
- NCT06999551
- Acronym / sponsor ID
- GRANT / GRANT2025
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, NPH, Insulin glargin, continuous glucose monitoring, efficacy, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient receiving NPH insulin | Experimental | Drug: switch NPH to glarginevaluating safety and efficacy after switching the patient receiving NPH into glargin insulin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| switch NPH to glarginSwitch of patients with type 2 diabetes mellitus from NPH insulin to insulin glargine | Drug | patient receiving NPH insulin |
Primary outcome
glycaemic variability on insulin glargine (after 12 weeks of use) versus NPH insulin (baseline)
Time frame: 4 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Results publication: PubMed 12677169Cohen 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.
- Results publication: PubMed 16235772Danielsson 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.
- Results publication: PubMed 15866065Hirsch 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabila Rekik, Professor principal investigator
STEDIAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing switch NPH to glargin in people with Diabetes Mellitus, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabila Rekik, Professor (98609300 ext. +216, nabila.rekik.mejdoub@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycaemic variability on insulin glargine (after 12 weeks of use) versus NPH insulin (baseline) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06999551, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.