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Medicine Science

Human Clinical Trials To Begin On Drug That Reverses Diabetes In Animal Models 140

Posted by Soulskill from the new-condition-is-called-Setebaid dept.
Zothecula writes: A study at the University of Alabama at Birmingham has shown that verapamil, a drug widely used to treat high blood pressure, irregular heartbeat and migraine headaches, is able to completely reverse diabetes in animal models. The UAB team will now move onto clinical trials to see if the same results are repeated in humans.
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Human Clinical Trials To Begin On Drug That Reverses Diabetes In Animal Models More

Human Clinical Trials To Begin On Drug That Reverses Diabetes In Animal Models

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  • What is the difference between an animal model and an animal used in scientific experimentation?

    • What is the difference between an animal model and an animal used in scientific experimentation?

      Animal models are SUPER-thin and pout a lot.

    • Re: (Score:2)

      by omems ( 1869410 )
      Nothing really. The term "model" is used because an animal with a disease is not the same as a human with the same disease. It is, at best, an approximation that has many similarities.

      You can find more at wikiP [wikipedia.org].

    • Re:Animal models (Score:5, Informative)

      by Shadow IT Ninja ( 3891909 ) on Friday November 07, 2014 @01:42PM (#48335583)
      An animal model is an animal which has been specifically engineered to resemble human disease. For example, there is a mouse model for melanoma which has a specifically engineered copy of the BRAF gene with a V600E mutation that occurs in about half of all human melanomas along with a knock out of the PTEN gene, also very common in human melanomas. These genes are fused to a tyrosenase promoter, which is only expressed in melanocytes in the skin, and a drug activator so that they can be turned on at a specific time and in the correct place. Melanoma is unknown in mice besides this model and previous cases created in the laboratory with chemical or ultraviolet mutagenesis. "Animal model" also implies some body of literature studying the engineered animal to verify that it really does resemble the human condition better than other practically available alternative experimental subjects.

    • Re: (Score:2)

      by gweihir ( 88907 )

      Statistics.

  • Type 1 or Type 2 Diabetes? (Score:3, Interesting)

    by riverat1 ( 1048260 ) on Friday November 07, 2014 @01:16PM (#48335289)

    Are they talking about type 1 diabetes (lack of insulin production) or type 2 diabetes (insulin resistance)? I suspect it's type 2 because fixing a pancreas that's not producing insulin would be quite difficult if not impossible.

    • Re: Type 1 or Type 2 Diabetes? (Score:5, Informative)

      by thehiddenones ( 2509386 ) on Friday November 07, 2014 @01:20PM (#48335337)
      It's type 1. I beleive they're doing it by inserting insulin - producing cells that won't get caught by the immune system.

    • Re: (Score:3, Informative)

      by Shadow IT Ninja ( 3891909 )
      TFA specifically says it's type 1 diabetes.

    • Re: (Score:2, Informative)

      by Anonymous Coward

      Type 1, actually. They've found a pathway that is involved in triggering beta cell death and a drug that supresses that pathway, leading to regeneration of beta cell mass in animal models. They're literally looking at a way of making the type 1 pancreas work again, which even if it's a little bit, will be able to do the fine-tuned control of insulin better than you ever can with a pump or injections. This is fantastic.

      • Type 1, actually. They've found a pathway that is involved in triggering beta cell death and a drug that supresses that pathway, leading to regeneration of beta cell mass in animal models. They're literally looking at a way of making the type 1 pancreas work again, which even if it's a little bit, will be able to do the fine-tuned control of insulin better than you ever can with a pump or injections. This is fantastic.

        It is, except that EVERY medication has side effects. Thanks, but I'm going to stick with insulin injections.

        Gastrointestinal side effects have included constipation (up to 11.7%), nausea (up to 2.7%), dyspepsia (up to 2.7%), and diarrhea (up to 2.4%). Nonobstructive, paralytic ileus (reversible upon discontinuation) has been reported infrequently. Diarrhea, dry mouth, gastrointestinal distress, and gingival hyperplasia have been reported.

        Cardiovascular side effects have included hypotension (up to 2.5%), new or worsened congestive heart failure (CHF) or pulmonary edema (negative inotropism; 1.8%), bradycardia (heart rate less than 50/minute; 1.4%), atrioventricular (AV) block (first-degree; up to 1.7%), AV block (total first-, second-, and third-degree; 1.2%), AV block (second- and third-degree; 0.8%), and postural hypotension (up to 0.4%). Symptomatic hypotension (1.5%), bradycardia (1.2%), and severe tachycardia (1%) have been reported with intravenous verapamil. In studies related to control of ventricular response in patients taking digoxin who had atrial fibrillation or atrial flutter, ventricular rate less than 50/minute at rest (15%) and asymptomatic hypotension (5%) were reported. Dizziness, hypotension, peripheral edema, and headache are not uncommon and are related to vasodilation of vascular smooth muscle. Verapamil may accelerate conduction of anomalous AV conduction tissue, as in the Wolff-Parkinson-White syndrome, which can result in worsened tachycardia, including malignant ventricular tachyarrhythmias or accelerated junctional tachycardia. Because of this potentially fatal side effect, verapamil is not recommended in patients with atrial fibrillation and premature ventricular depolarizations. Angina pectoris, AV block (second- and third-degree), atrioventricular dissociation, CHF, pulmonary edema, abnormal ECG, chest pain, claudication, hypertension, myocardial infarction, palpitations, and purpura (vasculitis) have been reported during open trials/postmarketing experience.

        CHF or pulmonary edema may be particularly important in patients with poor left ventricular function.

        Various conduction disturbances have been reported with verapamil therapy, including bradycardia, AV block, first-, second-, third-degree heart block, and left bundle branch block.

        Nervous system side effects have included headache (up to 12.1%), dizziness (up to 4.7%), lethargy (up to 3.2%), fatigue (up to 4.5%), sleep disturbances (up to 1.4%), paresthesia (up to 1%), and rare neurologic complaints (including paresthesias, sleeping problems, and tremors; less than 1%). Dizziness (1.2%), headache (1.2%), sleepiness, vertigo, and rare cases of seizures during injection have been reported with intravenous verapamil. Rare cases of muscle fasciculations in patients with underlying neuromuscular diseases, stroke associated with verapamil-induced hypotension, exacerbation of myasthenia gravis, and myoclonic dystonia have been reported. Cerebrovascular accident, confusion, equilibrium disorders, extrapyramidal symptoms, insomnia, paresthesia, shakiness, somnolence, syncope, and tinnitus have been reported during open trials/postmarketing experience.

        Other side effects have included flu syndrome (up to 3.7%), peripheral edema (up to 3.7%), edema (up to 3%), pain (up to 2.4%), fatigue (1.7%), accidental injury (up to 1.5%), ankle edema (up to 1.4%), and flushing (up to 0.8%).

        Immunologic side effects have included infection (up to 12.1%).

        Hepatic side effects have included elevated liver enzymes (up to 1.4%), and elevated transaminases with or without elevated serum bilirubin and alkaline phosphatase. The mechanism of injury is not known.

        Dermatologic side effects have included rash (up to 1.4%)

        Genitourinary side effects have included rare cases of sexual impotence and loss of libido among males. Gynecomastia, galactorrhea/hyperprolactinemia, impotence, increased urination, and spotty menstruation have been reported.

        Musculoskeletal side effects have included myalgia (up to 1.1%) and bizarre perceptual symptoms most closely described as cold extremities.

        Ocular side effects have included blurred vision.

    • Are they talking about type 1 diabetes (lack of insulin production) or type 2 diabetes (insulin resistance)? I suspect it's type 2 because fixing a pancreas that's not producing insulin would be quite difficult if not impossible.

      Nope, the title of the trial is:

      the re-purposing of verapamil as a beta cell survival therapy in type 1 diabetes

    • Type II.

      I dunno about this who thing. Verpamil is a common drug. Diabetes is a common problem. There exists data sets from the big insurers, systems like Kaiser and those nasty socialists, the Scandinavians, who have had computerized medical records for decades. It would seem easy to ask the question 'Are the glucose (or better yet Hemoglobin A1c [wikipedia.org]) levels) among patients taking verapamil and different from similar patients not taking the drug.

      You could get some pretty good data pretty quick. You would st

      • No, type I, ONE you damned keyboard. ONE. 1.

      • Type II.

        I dunno about this who thing. Verpamil is a common drug. Diabetes is a common problem. There exists data sets from the big insurers, systems like Kaiser and those nasty socialists, the Scandinavians, who have had computerized medical records for decades. It would seem easy to ask the question 'Are the glucose (or better yet Hemoglobin A1c [wikipedia.org]) levels) among patients taking verapamil and different from similar patients not taking the drug.

        You could get some pretty good data pretty quick. You would still need to do the prospective study, but you could get an idea if it made sense to go further.

        Of course, they could have done such a study - these puff piece articles aren't of the highest caliber.

        so... you didn't read it at all before posting or what?

        • Re: (Score:2)

          by geekoid ( 135745 )

          Maybe you should have read the whole thread? He corrected himself 2 minutes before you posted.

      • Re: (Score:2)

        by gweihir ( 88907 )

        You are missing that it might have to be given in a quite different regime and maybe quite different dosage. Other than that, how do you think they got the idea? Very likely there is a small, but statistically relevant effect in ordinary use of the drug.

    • The article states that it is for type 1 diabetes.

      Instead it is meant to lessen the amount of TXNIP to prevent the immune system from destroying beta cells. And it is only being given to folks who were recently diagnosed (last 3 months)?

      I think the title of this is all wrong, maybe I am misreading this, but it seems like it is meant to prevent body from destroying the few beta cells that are left. How can this cure diabetes? Is this treatment anything that can be used in folks (like myself) that have had

      • Re: (Score:2)

        by sjames ( 1099 )

        That is unknown for now. We don't know everything about the autoimmune reaction that destroys the beta cells in the first place.

        IF and it is an if, the autoimmune reaction is simply the starting trigger and the destruction is sustained by other follow-on effects, this might actually cure or lessen the disease in people who have been affected for a while.

        The thing is, the induced type I in mice is a very limited model, so all they can say for sure is that there is reason to believe it might be of some benefi

    • Re:Type 1 or Type 2 Diabetes? (Score:5, Informative)

      by wcrowe ( 94389 ) on Friday November 07, 2014 @02:10PM (#48335829)

      It's type 1 (which I have). It it not necessarily impossible to fix a pancreas that is not producing insulin, because very often, even a type 1 diabetic will have at least a few beta cells. If something can be done to prevent beta cells from being destroyed, the body can produce more, and then a healthy level of insulin can be maintained.

    • They are talking about both, but the first clinical trial will only use type I subjects.

  • Human models (Score:4, Interesting)

    by Extremus ( 1043274 ) on Friday November 07, 2014 @01:22PM (#48335363)

    If the drug is already in use (for other purposes), wouldn't we be able to see its effects on people already?

    • If the drug is already in use (for other purposes), wouldn't we be able to see its effects on people already?

      How do you think this all got started in the first place?

    • Anecdotal evidence, not scientifically controlled. A company seeks & the FDA has approve a chemical for the treatment of a specific condition. If they find additional uses, there is a whole additional battery of analysis on dosing, side-effects, etc. that needs to be done. 8mg of asprin a day to help improve heart health for some folks, but 400mg every 4 hours to treat clotting conditions. Same drug, very different uses, separately validated & approved.

  • Type 1 diabetes and type 2 diabetes are really not the same condition at all, although often the symptoms and treatment are similar. Much of the recent research has been into Type 1.

    Incidentally, I have type 2 diabetes and my body/mass index is exactly where it should be, I'm not overweight and never have been. It doesn't just affect big people.

    • Re: (Score:2)

      by itzly ( 3699663 )
      Body/mass index isn't necessarily a reliable indicator, though. Two people with identical weight and identical fat percentage can still differ in the place they carry the fat. Fat around internal organs can cause metabolic disorders, while the same amount of subcutaneous fat can be harmless.

    • Re: (Score:3)

      by wcrowe ( 94389 )

      One of the greatest disservices that has been done to people with diabetes is the notion that being overweight causes the disease. It can certainly contribute to it, but the bottom line is that it is a genetic disorder. I personally know three type 2 diabetics who have fine BMIs and get regular exercise. Myself, I was diagnosed as a type 2. I began exercising and lost 110 pounds. And yet I kept getting worse. It turns out that I was mis-diagnosed, and that I am a type 1. It just hit me later in life

  • This isn't a "cure" per say, as you'd still have to take verapamil on a daily basis. You'd just be replacing one drug (insulin) with another (verapamil). You'd need less insulin though, and the verapamil will probably help regulate glucose levels more closely. I'm sure verapamil comes with a nice list of side effects of it's own though.

    As someone with Type 1, I really want to be hopeful about this.....but it seems like we've been 5 years away from a cure for the last 30 years now.

    • Recently a Harvard doctor said he was able to get stem cells to turn into Beta Cells. http://hsci.harvard.edu/news/stem-cells-billions-human-insulin-producing-cells

      Maybe with this and the verapamil the body won't attack the Beta Cells...

      As a type 1 for a decade I understand the skepticism, but they seem to be closer these days. Also I would love to just take pills everyday for this rather than insulin injections and constant blood sugar monitoring.

      • Re: (Score:2)

        by gweihir ( 88907 )

        It just is that actual breakthroughs like the one needed here require a lot of time. 50-80 years from first successful lab demo to actually reliably working general deployment are quite standard in the history of science and technology. They are indeed closer, but they still need quite a bit of time.

    • As someone with Type 1, I really want to be hopeful about this.....but it seems like we've been 5 years away from a cure for the last 30 years now.

      I remember when I was a kid they predicted a cure for diabetes at about 5 years. This was 30 years ago, at least. As the years roll by I hate to sound like a conspiracy theorist but I don't believe they are looking for a cure. But are instead looking for other ways to treat it. There simply is no long term profits in a cure, but treatments are a different story. They can come up with new treatments every day.

      This maybe just a continuation of this cycle. Now they have one more drug they can get yo

      • I remember when I was a kid they predicted a cure for diabetes at about 5 years. This was 30 years ago, at least. As the years roll by I hate to sound like a conspiracy theorist but I don't believe they are looking for a cure. But are instead looking for other ways to treat it. There simply is no long term profits in a cure, but treatments are a different story. They can come up with new treatments every day.

        While I understand the feeling, I think there are plenty of decent scientists out there with a personal stake in finding a cure. Also, while this may hold true for drug companies, pharmacies and some doctors, the insurance companies would rather that everyone was cured. So while there are profits in treatment, there is also profit in a cure as well.

        • Re: (Score:1)

          by Anonymous Coward

          Yeah, one reassuring thing is the willingness of corporations to strangle the golden goose for short term profits. They totally would put out a cure and destroy a billion dollar a year market for short term profit.

        • It's also well worth a Nobel prize and the gratitude of millions of people worldwide.

    • I posted the list of known side effects here [slashdot.org]. There is NO way that I'm swapping 4 shots a day for this. It's not like the shots are all that bad - it's the glucose monitoring that's the pain. If a dog can sniff my blood sugar level, why can't we have a non-invasive glucometer?

  • New trial required? (Score:1)

    by Anonymous Coward

    Why not just find a bunch of diabetics with HBP who have been taking this drug and see if they really still have diabetes?

  • Can there be a real cure for diabetes? The glucose eaten can only have a few destinations:

    • 1. Get burnt,but obviously the limitation is how much physical activity the subject has
    • 2. Glycogene storage, which is limited
    • 3. Fat storage, almost unlimited
    • 4. Stay in blood for the kidney to remove it, this is diabetes

    What can we expect from a drug? Moving more glucose to fat storage? It is better than diabetes, but still much less desirable result than eating less carbs..

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