COMBO F1J-EW-HMGQ(a), version 21 July 2009

• Research type

  Research Study

• Full title

  Use of Duloxetine or Pregabalin in Monotherapy versus Combination Therapy of Both Drugs in Patients with Painful Diabetic Neuropathy “The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study”

• IRAS ID

  21831

• Sponsor organisation

  Eli-Lilly and Company

• Eudract number

  2009-010063-16

• ISRCTN Number

  n/a

• Research summary

  Diabetic Peripheral Neuropathic Pain (DPNP) is experienced by approximately 66% of people with Type 1 diabetes and 59% of people with Type 2 diabetes (Dyck et al. 1993). It is usually described as an ??aching, burning, stabbing or shooting? sensation most commonly in the feet and sometimes in the hands as well. It results from nerve damage caused by long-term, poorly controlled levels of blood sugar in people with diabetes. The current treatment for DPNP includes the use of antidepressants (such as duloxetine), anticonvulsants (such as pregabalin) and opioids (such as oxycodone). The aim of this study is to compare the use of duloxetine and pregabalin in monotherapy (treatment with one medication) against combination therapy (treatment with two or more medications) for patients with DPNP. In this study, patients will be randomly assigned to four different treatment groups (1, 2, 3 and 4). There is an equal chance of being randomised to each group. For the first 8 weeks groups 1 and 2 will receive standard daily doses of duloxetine and groups 3 and 4 will receive standard daily doses of pregabalin. After 8 weeks all patients who do not respond to their initial treatment will go on to receive a further 8 weeks of treatment. * Group 1 will receive a higher daily dose of duloxetine. * Groups 2 and 3 will receive a combination of standard daily dosesof duloxetine and pregabalin. * Group 4 will receive a higher daily dose of pregabalin. Eli Lilly and Company are funding the study. Approximately 800 patients will be randomised worldwide with approximately 60 recruited from the UK. Reference:Dyck PJ, Kratz KM, Karnes JL, Litchy WJ, Klein R, Pach JM, Wilson DM, O??Brien PC, Melton LJ. 1993. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: The Rochester Diabetic Neuropathy Study. Neurology 43:817-824

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/100

• Date of REC Opinion

  13 Oct 2009

• REC opinion

  Further Information Favourable Opinion