Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients

Summary

Primary Objective: To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL). Secondary Objective: A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of: * Glycaemic parameters: 7 blood glucose profiles * Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia * Change in lipid status

Timeline

Start

2009-06

Primary completion

2012-10

Completion

2012-10

Publications

• Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
• Hermanns N, Kulzer B, Kohlmann T, Jacob S, Landgraf W, Theobald K, Haak T. Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents--a randomized, prospective, crossover, open clinical trial. Health Qual Life Outcomes. 2015 Jun 9;13:77. doi: 10.1186/s12955-015-0279-4.

Drugs

Indications