Efficacy and safety of using insulin glargine 300 U/mL in patients with type 2 diabetes on basal insulin and oral antidiabetic drugs failing to achieve their blood sugar targets

Not Applicable

Completed

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

• Registration Number: ISRCTN56991780
• Lead Sponsor: Sanofi-Aventis Deutschland GmbH

Brief Summary

2016 Abstract results in https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0036-1580971 conference abstract 2018 Abstract results in https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0038-1641918 conference abstract 2018 Abstract results in https://diabetes.diabetesjournals.org/content/67/Supplement_1/1020-P conference abstract 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/30302721/ (added 19/04/2021) 2021 Results article in https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14549 (added 09/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-12-27
• Study Start: 2019-07-03
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Patients with type 2 diabetes (basal insulin and oral antidiabetic drugs) with any basal insulin except insulin glargine 300 U/mL
2. Adults and seniors: age at least 18 years, no upper age limit
3. HbA1c between 7.5% to 10.0%
4. Fasting blood glucose > 130 mg/dL
5. Ability and willingness to perform blood glucose self-monitoring

Exclusion Criteria

1. Type 1 diabetes
2. Contraindications for therapy with insulin glargine 300 U/mL
3. Existing insulin therapy with basal and bolus Insulin (i.e. basal-bolus insulin therapy, premixed 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
Fasting blood glucose (FBG) 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 two FBG values = 110 mg/dL (= 6.1 mmol/L) within the respective observational period. Response rates were summarized with frequency distribution and, in addition, adjusted frequency distribution considering only patients with nonmissing data. Exact 95% confidence intervals (CI) according to Clopper-Pearson were calculated.