Efficacy and safety of using insulin glargine in patients with type 2 diabetes on non-insulin antidiabetic therapy failing to achieve control of blood sugar: the Toujeo-1 trial

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus in adult patients requiring basal insulin therapy.; Nutritional, Metabolic, Endocrine; Type 2 diabetes

• Registration Number: ISRCTN12809144
• Lead Sponsor: Sanofi-Aventis Deutschland GmbH

Brief Summary

2016 Abstract results in https://dx.doi.org/10.1055/s-0036-1580970 conference abstract 2018 Abstract results in https://dx.doi.org/10.1055/s-0038-1641916 conference abstract 2018 Abstract results in https://diabetes.diabetesjournals.org/content/67/Supplement_1/1027-P conference abstract 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31903680 results (added 02/04/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32753920/ (added 04/07/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-12-21
• Study Start: 2019-06-25
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1748

Inclusion Criteria

1. Patients with type 2 diabetes (oral antidiabetic drugs).
2. Adults and Seniors: Age at least 18 years, no upper age limit.
3. HbA1c between 7.5% to 10.0%.
4. Ability and willingness to perform blood glucose self-monitoring.

Exclusion Criteria

1. Type 1 diabetes.
2. Contraindications for a therapy with insulin glargine 300 U/mL.
3. Any kind of existing insulin therapy.
4. Patients with known cancer disease.
5. Pregnancy.
6. Drug or alcohol abuse.
7. Dementia or general incapacity to understand the content of the observational study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c response rate during month 1-6 and month 1-12 after start of insulin glargine 300 U/mL treatment, respectively; Response being defined as achieving at least one HbA1c value below the predefined individual target value within the respective observational period. Response rates were summarized with frequency distribution and, in addition, adjusted frequency distribution considering only patients with non-missing data. Exact 95% confidence intervals (CI) according to Clopper-Pearson were calculated.