drugset / Trial / NCT01570751
A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
RandomizedCrossoverOpen-labelTreatment
Summary
This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.
Timeline
- Start
- 2012-04
- Primary completion
- 2014-01
- Completion
- 2014-01
Publications
- Results Warren ML, Chaykin LB, Jabbour S, Sheikh-Ali M, Hansen CT, Nielsen TSS, Norwood P. Insulin Degludec 200 Units/mL Is Associated With Lower Injection Frequency and Improved Patient-Reported Outcomes Compared With Insulin Glargine 100 Units/mL in Patients With Type 2 Diabetes Requiring High-Dose Insulin. Clin Diabetes. 2017 Apr;35(2):90-95. doi: 10.2337/cd15-0058.
- Warren ML, Brod M, Hakan-Bloch J, Sparre T, Chaykin LB. Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes. Curr Med Res Opin. 2019 Sep;35(9):1623-1629. doi: 10.1080/03007995.2019.1605769. Epub 2019 May 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin degludec | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |