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Study to evaluate the efficacy and safety of switching to insulin glargine 300 U/ml from insulin glargine 100 U/ml in patients with type 2 diabetes with renal failure
EU CTIS ID: 2024-518403-22-00
What this study is testing
To evaluate the efficacy and safety of switching treatment with insulin glargine 100U/ml (Gla-100) to Insulin glargine 300U/ml (Gla-300) using CGM in patients with T2DM and renal impairment
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Signed informed consent
- 2. Patients with DM ≥ 18 years of age
- 3. Diagnosed with Type 2 Diabetes Mellitus ≥ 3 years prior to study enrolment.
- 4. Participants currently treated with Gla-100 for at least 4 months prior to enrolment with or without oral antidiabetics.
- 5. HbA1c ≥ 7.5 y < 9% within 3 months prior to enrolment.
- 6. Estimated Glomerular filtration Rate (eGFR) between 30-60 ml/min at least 4 weeks prior to enrollment
You likely can't join if
- 1. Pregnant or lactating women
- 2. Patients who have been hospitalized for more than 7 days in the month prior to recruitment
- 3. Presence of disease / treatment, which in the opinion of the investigator, affects the control of diabetes (e.g., chemotherapy, immunosuppressants, systemic corticosteroids)
- 4. Participants enrolled during the study period in another clinical study.
- 5. Participants with basal-bolus regimen
See the full eligibility criteria
- 1. Signed informed consent
- 2. Patients with DM ≥ 18 years of age
- 3. Diagnosed with Type 2 Diabetes Mellitus ≥ 3 years prior to study enrolment.
- 4. Participants currently treated with Gla-100 for at least 4 months prior to enrolment with or without oral antidiabetics.
- 5. HbA1c ≥ 7.5 y < 9% within 3 months prior to enrolment.
- 6. Estimated Glomerular filtration Rate (eGFR) between 30-60 ml/min at least 4 weeks prior to enrollment
- 7. BMI between 25 and 40 kg/m2
- 8. Ability and willingness to wear the Freestyle IQ Pro as required by the protocol Signed informed consent form
- 1. Pregnant or lactating women
- 2. Patients who have been hospitalized for more than 7 days in the month prior to recruitment
- 3. Presence of disease / treatment, which in the opinion of the investigator, affects the control of diabetes (e.g., chemotherapy, immunosuppressants, systemic corticosteroids)
- 4. Participants enrolled during the study period in another clinical study.
- 5. Participants with basal-bolus regimen
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.