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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi Aventis S.A.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

20 Jun 2022 → 9 Jul 2025

Decision date (initial)

2025-01-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

SANOFI AVENTIS

External identifiers

EU CT number

2024-518403-22-00

EudraCT number

2021-005353-82

WHO UTN

U1111-1266-7282

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

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

Secondary objectives 8

1. 1. Determine glycemic variability and control during a 24-hour evaluation period (full period, daytime and night) from the data collected from the MCG.
2. 2. Determine the effectiveness of the treatment regimen of Gla 300 versus Gla-100 using data collected from the Clinical History in Electronic format (EHR).
3. 3. Evaluate the safety and tolerability profile during a 24-hour evaluation period (full daytime period and night) from the data collected from the CGM
4. 4. Describe the incidence and severity of the events documented hypoglycemia with Gla-300 and with pretreatment (Gla-100) using collected data of the EHR.
5. 5. Describe the incidence of adverse events other than documented hypoglycemias with Gla-300 and with pretreatment (Gla-100) using collected data of the EHR.
6. 6. Describe the characteristics of the patients using the data collected from the EHR.
7. 7. Describe the patient's treatment patterns using the data collected from the EHR.
8. 8. Determine patient satisfaction after the change in their treatment using the “Diabetes status” questionnaire Treatment Satisfaction Questionnaire” (DTSQs) and the “change Diabetes Treatment Satisfaction” questionnaire Questionnaire” (DTSQc)

Conditions and MedDRA coding

Diabetes mellitus II

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Signed informed consent
2. 2. Patients with DM ≥ 18 years of age
3. 3. Diagnosed with Type 2 Diabetes Mellitus ≥ 3 years prior to study enrolment.
4. 4. Participants currently treated with Gla-100 for at least 4 months prior to enrolment with or without oral antidiabetics.
5. 5. HbA1c ≥ 7.5 y < 9% within 3 months prior to enrolment.
6. 6. Estimated Glomerular filtration Rate (eGFR) between 30-60 ml/min at least 4 weeks prior to enrollment
7. 7. BMI between 25 and 40 kg/m2
8. 8. Ability and willingness to wear the Freestyle IQ Pro as required by the protocol Signed informed consent form

Exclusion criteria 5

1. 1. Pregnant or lactating women
2. 2. Patients who have been hospitalized for more than 7 days in the month prior to recruitment
3. 3. Presence of disease / treatment, which in the opinion of the investigator, affects the control of diabetes (e.g., chemotherapy, immunosuppressants, systemic corticosteroids)
4. 4. Participants enrolled during the study period in another clinical study.
5. 5. Participants with basal-bolus regimen

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline to Month 5 in the percentage of Time in Range (TIR)

Secondary endpoints 9

1. Mean glucose profile over 24 hours
2. % Coefficient of variation
3. % Time below target glucose Range (TBR)
4. % Time above target glucose Range (TAR)
5. Change from baseline to Month 5 in HbA1c
6. Change from baseline to Month 5 in Fasting Plasma Glucose (FPG)
7. Number of participants with at least one hypoglycemia event
8. Change from baseline to Month 5 in DTSQc
9. Number of participants with adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi Aventis S.A.

Sponsor organisation

Sanofi Aventis S.A.

Address

Calle Rossello I Porcel 21

City

Barcelona

Postcode

08016

Country

Spain

Scientific contact point

Organisation

Sanofi Aventis S.A.

Contact name

Fernando

Public contact point

Organisation

Sanofi Aventis S.A.

Contact name

Fernando

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications