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
2007

Study on Cycloset™ for Type 2 Diabetes Treatment

Sample size: 3095 publication Evidence: moderate

Author Information

Author(s): Richard E Scranton, J Michael Gaziano, Dean Rutty, Michael Ezrokhi, Anthony Cincotta

Primary Institution: Veroscience LLC, Harvard Medical School

Hypothesis

The rate of all-cause serious adverse events after one year of usual diabetes therapy plus Cycloset™ is not greater than that for usual diabetes therapy plus placebo.

Conclusion

The study aims to evaluate the safety and efficacy of Cycloset™ in individuals with type 2 diabetes.

Supporting Evidence

  • Cycloset™ has been shown to reduce insulin resistance and improve glycemic control in clinical trials.
  • The study includes a large sample size of 3,095 participants.
  • Participants are randomized in a 2:1 ratio to receive either Cycloset™ or placebo.

Takeaway

This study is testing a new diabetes medication called Cycloset™ to see if it is safe and helps people with diabetes better than a sugar pill.

Methodology

A double-blind, multi-center, placebo-controlled trial with a 2:1 randomization ratio over one year.

Potential Biases

Potential conflicts of interest due to authors' affiliations with the developing company.

Limitations

The study may not account for all potential confounding factors affecting diabetes management.

Participant Demographics

Individuals aged 30-80 with type 2 diabetes and HbA1c ≤ 10%.

Statistical Information

Confidence Interval

1.5

Digital Object Identifier (DOI)

10.1186/1472-6823-7-3

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