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PR release on oral insulin pill opened door to questions about benefits, evidence

Oramed Announces Positive Top-Line Results from Phase IIb Oral Insulin Study

Our Review Summary

pillThis is a news release about progress toward a long-elusive goal — a pill form of insulin that eliminates the need for injections. It describes what appears to be a well-designed, randomized clinical trial powered with enough patients to achieve a significant result. Although it cites percent reduction in blood glucose values, it might have been stronger had it also included absolute reductions — from what to what. And it could have been more specific about what possible side effects might have been of concern.

The release also lacks context for understanding how the new drug’s effects might compare with those of injectable insulin or other drugs used in this clinical situation.

A Reuters story on the drug, which seemed to rely heavily on this news release, was also reviewed by HealthNewsReview.org.

 

Why This Matters

The first line treatment for type 2 diabetes is usually weight loss (for those who are overweight) plus metformin.  However, many people with diabetes are unable to achieve control of blood glucose with these measures, and a second drug must be added. Injectable night-time insulin is one option, but many people balk at the idea of giving themselves a shot every night. The potential to deliver insulin in pill form would be a welcome alternative — if future trials bear out its usefulness.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Applicable

The story does not discuss costs but the drug is not approved for use — and may never be.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The news release contains a lot of good information. It describes the study of 180 adults with type 2 diabetes as double-blind, 28-day, and randomized. It notes that those who took the experimental treatment had a statistically significant decrease in their night-time blood sugar of more than 6%.

Had it also divulged the mean values of the absolute numbers, that information might have helped the reader determine whether the drop was clinically significant. It would also be helpful to know the percent reduction in blood glucose that is achieved with standard injectable insulin for comparison.

The news release also states as a benefit that people with type 2 diabetes might be more likely to be compliant about taking an insulin in pill form rather than by injection, but it does not offer evidence to support that suggestion.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

“The study additionally demonstrated a good safety profile with no drug-related serious adverse events,” we are told. The news release does not say what a “good safety profile” means, nor does it say whether any not-so serious adverse events may have occurred.

It would be especially important to report hypoglycemia (low blood sugar), which is a common complication of injectable insulin therapy.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The news release describes the design of the study well. But it would have been stronger had it included absolute numbers in describing the reduction of blood sugar levels. And it would have helped to know whether the 6.47% drop in blood sugar was enough to move patients into the range of normal blood sugars. Is a 6.4% reduction in glucose large enough to achieve reduction in long-term complications of diabetes? Although this study is not designed to examine long-term outcomes of therapy, it could have provided more context that showed how the percentage of glucose reduction correlates with reduction in complications.

Does the news release commit disease-mongering?

Not Satisfactory

The news release does not say how common type 2 diabetes is and therefore cannot be accused of disease mongering. But the figures are astounding, with a quadrupling of cases since 1980, according to the World Health Organization.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The news release states that Oramed Pharmaceuticals conducted the study.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release does not say whether an insulin pill would be better than other ways of lowering blood sugar, such as exercise, diet or sulfonylurea drugs which stimulate the pancreas to release more insulin.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The news release makes it clear that the drug remains experimental.

Does the news release establish the true novelty of the approach?

Satisfactory

The news release notes that this drug would be the first oral form of insulin for type 2 diabetes.

Total Score: 5 of 9 Satisfactory

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