Hedi Chaker Hospital
Sfax, 3000, Tunisia
NCT Number: NCT06999551
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
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 4
Sfax, 3000, Tunisia
Follow-up visits will include :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Switch of patients with type 2 diabetes mellitus from NPH insulin to insulin glargine
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.
Contact information is provided by the study sponsor or research team.
Les Laboratoires des Médicaments Stériles
Industry
Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in the Treatment of Diabetes Type 2, in Tunisian Patients.
Acronym: GRANT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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