It looks like Isis Pharmaceuticals (ISIS) time-shifted the analysis of a diabetes drug clinical trial to sweeten the results.
In a Tuesday morning release, Isis said that type 2 diabetics treated with its experimental antisense drug ISIS-PTP1B Rx achieved statistically significant reductions in hemoglobin (HbA1c) and body weight, compared with a placebo at 36 weeks.
OK, except the phase II study was designed to assess comparative changes in hemoglobin and body weight at 27 weeks, not 36 weeks, according to a description of the study on ClinicalTrials.gov. (Hat tip to @lomu_j for first noticing the discrepancy.)
What was the effect of ISIS-PTP1B Rx at 27 weeks? Isis doesn't disclose.
In addition to assessing changes in HbA1c at 27 weeks, the study's other primary end point measures the "incidence, severity, dose relationship of adverse effects and changes in laboratory evaluations as a measure of safety" at 38 weeks.
As it often does when disclosing study results via press release, Isis offered few details about the safety of ISIS-PTP1B Rx other than to say that the drug was "generally well tolerated" with "infrequent" injection site reactions, no flu-like symptoms and no "clinically significant" laboratory abnormalities.
Isis' only approved drug, Kynamro, causes injection-site reactions in 84% of patients and flu-like symptoms in 30% of patients, according to its Food and Drug Administration label.
Kynamro also carries a black-box safety warning for an increased risk in liver toxicity.
ISIS-PTP1B Rx is designed to inhibit the production of a protein that negatively affects insulin activity in diabetics.
In the phase II study of 92 type II diabetics, treatment with ISIS-PTP1B Rx for 26 weeks led to a mean reduction in HbA1c of 0.7 percentage points from baseline, measured at 36 weeks, compared with a mean reduction of 0.2 percentage points for patients treated with a placebo.
The difference was statistically significant, Isis said, though, again, the measurement at 36 weeks wasn't pre-specified in the trial design.
Isis also said that patients treated with ISIS-PTP1B Rx experienced a mean reduction in body weight "from baseline" at 36 weeks that was statistically significant.
The company made no mention of weight loss (or gain) in placebo-treated patients.
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