Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes

Summary

Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities. The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin. While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated as well.

Timeline

Start

2004-07

Primary completion

2007-01

Completion

2007-01

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper compared with 98 (9.6%) in the placebo group (HR 1.02 [96% one-sided CI 1.27]). PMID 20332352 ↗

Publications

• Background Scranton RE, Gaziano JM, Rutty D, Ezrokhi M, Cincotta A. A randomized, double-blind, placebo-controlled trial to assess safety and tolerability during treatment of type 2 diabetes with usual diabetes therapy and either Cycloset or placebo. BMC Endocr Disord. 2007 Jun 25;7:3. doi: 10.1186/1472-6823-7-3.
• Results Gaziano JM, Cincotta AH, O'Connor CM, Ezrokhi M, Rutty D, Ma ZJ, Scranton RE. Randomized clinical trial of quick-release bromocriptine among patients with type 2 diabetes on overall safety and cardiovascular outcomes. Diabetes Care. 2010 Jul;33(7):1503-8. doi: 10.2337/dc09-2009. Epub 2010 Mar 23.
• Chamarthi B, Cincotta AH. Effect of bromocriptine-QR therapy on glycemic control in subjects with type 2 diabetes mellitus whose dysglycemia is inadequately controlled on insulin. Postgrad Med. 2017 May;129(4):446-455. doi: 10.1080/00325481.2017.1315290. Epub 2017 Apr 12.
• Chamarthi B, Ezrokhi M, Rutty D, Cincotta AH. Impact of bromocriptine-QR therapy on cardiovascular outcomes in type 2 diabetes mellitus subjects on metformin. Postgrad Med. 2016 Nov;128(8):761-769. doi: 10.1080/00325481.2016.1243003. Epub 2016 Oct 11.
• Chamarthi B, Gaziano JM, Blonde L, Vinik A, Scranton RE, Ezrokhi M, Rutty D, Cincotta AH. Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus. J Diabetes Res. 2015;2015:157698. doi: 10.1155/2015/157698. Epub 2015 Apr 28.
• Gaziano JM, Cincotta AH, Vinik A, Blonde L, Bohannon N, Scranton R. Effect of bromocriptine-QR (a quick-release formulation of bromocriptine mesylate) on major adverse cardiovascular events in type 2 diabetes subjects. J Am Heart Assoc. 2012 Oct;1(5):e002279. doi: 10.1161/JAHA.112.002279. Epub 2012 Oct 25.

Drugs

Indications