LEVEX STUDY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a two-site, prospective, randomized, open-label, parallel group, controlled trial of up to 24 weeks in patients with Type 2 Diabetes Mellitus who have poor control as defined by an HgBA1C between 7.5% and 10%. The hypothesis is that insulin detemir will be non-inferior to exenatide. As many as 74 patients (24 at MRI and 50 at WRAMC) will be randomized to either detemir or exenatide with stratification for TZD use. They will continue their oral agent therapy. Phase 1 is 12 weeks and patients not achieving goal A1C will enter a 12 week Phase 2 where they will receive both the initial medication and the alternative agent. Patients who do achieve goal A1C in Phase 1 will be continued on that single agent. The primary outcome is A1C improvement with secondary outcomes including frequency of hypo and hyperglycemia, weight, change in body composition, lipid levels, biometric parameters of activity, heat flux, galvanic skin response, and heart rate.