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Ascend plus clinical trial

I have heard back from AscendPlus as follows:
Ascend Plus is a UK-wide clinical trial testing to see if semaglutide may help protect against heart attacks, strokes and circulatory problems in individuals with Type 2 diabetes.

1) In some individuals, weight loss is a side effect they can experience so you should consider this particularly if you are already of low weight and low BMI.
2) Your blood sugar levels should continue to be monitored by your GP and the trial will not monitor these.
3) Taking sitagliptin should not impact your participation in the trial.

I'll now ponder if it is worth starting the trial...I suppose if I get the placebo I should have no side effects, and if I get the drug and it causes weight loss, I can stop...
 
I have been invited to this study as well but it does say that some people will have the study drug some will have placebo. I don’t think I will qualify for the study as I am 11 and half stone. I am not doing the trial as I need to go on more medication which is the same as the trial med, not overweight by much and need the meds cause having trouble with high blood sugars and I don’t want placebo. I use to work as a clinical research nurse doing first in to man drug trials, I would do trials to further research treatment usually but sadly not this time.
 
I signed up for it last summer and did the run in (3mg Semiglutide for 4 weeks then 7mg for 8 weeks) and am now on the placebo. My understanding from the literature is that if your GP thinks you need semiglutide at any point, then you’d just opt out of the study. I figured there was nothing to loose by volunteering as I’d be no worse off on the placebo and if I’d been picked for the live tablets then there was a potential gain in protection against heart attack/stroke - my father died at 54 from a heart attack caused by undiagnosed T2 so I had an extra driver.
I didn’t realise until I went onto the main trial and the placebo that I had felt slightly off when on the 7mg and even though my low-ish carb diet is very boring, it was nice to feel hungry and look forward to food again LOL
For whoever thought they were maybe too light - I was around the top end of normal BMI when I joined the scheme - maybe that was a factor in me ending up on the placebo - who knows how the ‘randomisation’ works!
You can opt out at any point
 
I rejected my invite to the trial as I am no medication and didn't relish having potentially if it was not placebo to take something I didn't need as my HbA1C is normal and maintained by diet only.
 
Ph1l said:
I signed up for it last summer and did the run in (3mg Semiglutide for 4 weeks then 7mg for 8 weeks) and am now on the placebo. My understanding from the literature is that if your GP thinks you need semiglutide at any point, then you’d just opt out of the study. I figured there was nothing to loose by volunteering as I’d be no worse off on the placebo and if I’d been picked for the live tablets then there was a potential gain in protection against heart attack/stroke - my father died at 54 from a heart attack caused by undiagnosed T2 so I had an extra driver.
I didn’t realise until I went onto the main trial and the placebo that I had felt slightly off when on the 7mg and even though my low-ish carb diet is very boring, it was nice to feel hungry and look forward to food again LOL
For whoever thought they were maybe too light - I was around the top end of normal BMI when I joined the scheme - maybe that was a factor in me ending up on the placebo - who knows how the ‘randomisation’ works!
You can opt out at any point
Click to expand...
Did they tell you that you are on the placebo? I have only received the invitation and am waiting for further details before I finally decide. The trials I have been on in the past have been "blind" so that you didn't know if you were on the placebo or the medication. In fact, one was a "double blind" so that the nurses or doctor did not know.
 
I decided to start the trial and am 2 weeks into the run-in phase, meaning I am on the lower Semaglutide dose. So far, so good. My weight seems unaffected, and I have no loss of appetite, just some subtle changes to my hunger and eating behaviour. I've not had diarrhoea, constipation or nausea to any degree, but my system was a bit disrupted for a few days. Results of the few blood-sugar self-tests I've done are certainly not worse, and BP seems unaffected. I'm pleasantly surprised.

My understanding is that this is a "double-blind" trial and I will not be told whether I am on the drug or placebo. However, given that the trial starts with taking trial doses of the drug, I'm sure that anyone who monitors their blood sugar levels will observe a difference if given the placebo after several months on the drug in the run-in. Likewise regarding side effects.

Regarding how they allocate the drug/placebo, I doubt this will depend on the circumstances of the patient (overweight, underweight, etc), as I assume that anyone not suited to take the drug would not be invited to participate. Also, I believe the purpose of the run-in is to eliminate participants who cannot tolerate the drug, but I'm no expert on clinical trials!

Based on my experience so far, I encourage others to volunteer for the trial - you can opt out at any time, as I nearly did before taking the first pill!
Regards, Nick.
 
EMcKT said:
I have been invited to take part in this clinical trial because I fit the parameters of the study.....over 65 and type 2 diabetic.
The aim of the study is to find out whether oral semaglutide can prevent heart and circulation problems in " a broad range of people living with type 2 diabetes who have never had a heart attack or stroke". Now I have taken part in trials before and where would we be if nobody did it, but I'm in two minds. Working on the presumption that I would have to change or add in new medication, I'm not keen. At present I'm on 2 x 500 mg Metformin daily as well as my basic meds and I'm fine. Next Hba1c is not due till March, B12 Jag is Monday.......and may have bloods done sooner.
I am asking if anyone else has had this request and what do others think? I know it's my decision but am interested in opinions.
Click to expand...
Yes I got this too. But I need to take insulin as well as 2 x metformin. I’ve got my hbac1 down to 38 and I’m nearly 100% time in range. I’m definitely not prepared to come off insulin. Apart from blood sugar, I’m in very good health. Healthy BMI, cholestrol, BP, lots of exercise etc. My QRISK2 is only 8.7, considered low risk even for a non diabetic. So I can’t really see what benefit it would be for me, probably increasing my hbac1 substantially, and dangerously if I was on the placebo, or them as I’m not at risk for the conditions they’re researching. I’m just not prepared to undo all my hard work. I’m 60 and meet the criteria, but wonder whether anything is considered apart from being type 2.
 
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Thanks for your update @Nick Cliff

Yes that’s my understanding about run-in periods for trials too. How long is the run-in phase?
 
everydayupsanddowns said:
Thanks for your update @Nick Cliff

Yes that’s my understanding about run-in periods for trials too. How long is the run-in phase?
Click to expand...
It's 4 weeks at 3mg Semaglutide once daily dose, then 8 weeks at 7mg daily dose. Following that, you go into the randomised double-blind trial proper, so either 14mg daily dose or a placebo.
 
I've been following this thread with interest. I've expressed an interest and am waiting to receive further details along with the form. I usually agree to take part in trials without much further thought. I entered the AddAspirin trial that looked at the effects of aspirin and the recurrence of cancer but I had to come off that trial because of one of the side effects of aspirin. Either I was on the aspirin and had a genuine side effect or there was a psychosomatic response to the placebo. Other trials have been fine. This time I'm trying to weigh up the pros and cons because of the other meds I am taking for diabetes and some other issues. I'll see what comes back and talk to the trial nurses before eventually deciding but I have found this thread very useful in helping my thought process.
 
Nick Cliff said:
It's 4 weeks at 3mg Semaglutide once daily dose, then 8 weeks at 7mg daily dose. Following that, you go into the randomised double-blind trial proper, so either 14mg daily dose or a placebo.
Click to expand...

Ah interesting, so the run-in is only really to gradually ramp you up to the dose they want to examine in the trial, and means you don’t have to suddenly start on full dose with the likelihood of gastric effects.
 
EMcKT said:
I have been invited to take part in this clinical trial because I fit the parameters of the study.....over 65 and type 2 diabetic.
The aim of the study is to find out whether oral semaglutide can prevent heart and circulation problems in " a broad range of people living with type 2 diabetes who have never had a heart attack or stroke". Now I have taken part in trials before and where would we be if nobody did it, but I'm in two minds. Working on the presumption that I would have to change or add in new medication, I'm not keen. At present I'm on 2 x 500 mg Metformin daily as well as my basic meds and I'm fine. Next Hba1c is not due till March, B12 Jag is Monday.......and may have bloods done sooner.
I am asking if anyone else has had this request and what do others think? I know it's my decision but am interested in opinions.
Click to expand...
Are you already on semiglutide or do they want you to start it ?
 
I received the further details. I was still undecided and so I sent an email with some questions. One of the researchers phoned back and we had a really good discussion. It is important to remember that the research is not looking at the participants' diabetes management. That is left to the patient and the existing GP/diabetes nurse etc. The GP will be told that you are in the trial but neither the GP nor the participant will know whether the participant is on the placebo or medication. There is fairly detailed assessment to be completed before entering the trial. The trial starts off with a low dose of semaglutide (as already mentioned by Nick Cliff). The dose is increased and then you are given either the semaglutide or placebo when you enter the trial. As far as taking semaglutide and sitagliptin, they have received confirmation from various specialists that there should be no conflict between the two. Although they work in slightly different ways and are not usually prescribed together, there is nothing to prevent them being used in conjunction. The assessment had questions about chemotherapy and treatment on the lungs. So, because of the various treatments I have had for cancer and the fact that I am still undergoing follow up scans, I have decided not to enter the trial. As I said above, I have participated in trials in the past and am disappointed that I will not be taking part in this one.
 
Well done for looking into it carefully @JimG

Hopefully there will be other opportunities in the future it’ll be easier for you to participate in.
 
Nick Cliff said:
I decided to start the trial and am 2 weeks into the run-in phase, meaning I am on the lower Semaglutide dose. So far, so good. My weight seems unaffected, and I have no loss of appetite, just some subtle changes to my hunger and eating behaviour. I've not had diarrhoea, constipation or nausea to any degree, but my system was a bit disrupted for a few days. Results of the few blood-sugar self-tests I've done are certainly not worse, and BP seems unaffected. I'm pleasantly surprised.

My understanding is that this is a "double-blind" trial and I will not be told whether I am on the drug or placebo. However, given that the trial starts with taking trial doses of the drug, I'm sure that anyone who monitors their blood sugar levels will observe a difference if given the placebo after several months on the drug in the run-in. Likewise regarding side effects.

Regarding how they allocate the drug/placebo, I doubt this will depend on the circumstances of the patient (overweight, underweight, etc), as I assume that anyone not suited to take the drug would not be invited to participate. Also, I believe the purpose of the run-in is to eliminate participants who cannot tolerate the drug, but I'm no expert on clinical trials!

Based on my experience so far, I encourage others to volunteer for the trial - you can opt out at any time, as I nearly did before taking the first pill!
Regards, Nick.
Click to expand...
Ah well, sadly I spoke too soon..
By about 5 days after that post, 22 days into the run-in, my guts slowed to a standstill, with trapped wind, some heartburn and nausea, giving a sleepless night. On holiday at the time, I stopped taking the tablets, ending the worst symptoms and gradually returning to normal. I spoke to a study team doctor, who advised that if I was having such side effects with the lowest dose, it would be wrong for me to continue in the trial. Also, stopping and restarting would breach the strict protocols of the trial. So, in the words of a 'dragon', "I'm Out".. unfortunately.

This shouldn't put others off attempting the trial. We're all different, so may not get these side effects. The study team were extremely prompt and helpful regarding queries I had before starting the trial and over this side effects issue, and the information and instructions provided are very clear.

Of interest is that the side effects were very similar to those I had when starting (and stopping!) Metformin a few years back - except with Metformin I had a loss of appetite, and loss of weight, neither of which occurred in this trial with Oral Semaglutide. I had not anticipated the same symptoms as I understood the pharmacology of the drugs to be quite different, although in the "small print" both Metformin and Semaglutide are believed to impact neural pathways involved in appetite and satiation in addition to their major impact on hormone messaging, etc.
 
I echo your comments about the helpfulness of the research team. When I decided not to go onto the trial, I sent a detailed email giving my reasons. The way I look at it, you and I have both engaged with the trial and my not starting and your withdrawing will form part of the results of the trial. At least we tried.
 
JimG said:
I've been following this thread with interest. I've expressed an interest and am waiting to receive further details along with the form. I usually agree to take part in trials without much further thought. I entered the AddAspirin trial that looked at the effects of aspirin and the recurrence of cancer but I had to come off that trial because of one of the side effects of aspirin. Either I was on the aspirin and had a genuine side effect or there was a psychosomatic response to the placebo. Other trials have been fine. This time I'm trying to weigh up the pros and cons because of the other meds I am taking for diabetes and some other issues. I'll see what comes back and talk to the trial nurses before eventually deciding but I have found this thread very useful in helping my thought process.
Click to expand...
Hi @JimG I did the AddAspirin trial also - following treatment for Prostate Cancer. I had no issues and finished the trial. I perceived that small bleeds seemed to take a bit longer to staunch, so figured I was on the Aspirin, but will never know. Don't blame you for opting out of AscendPlus based on what you say in your other post. Cheers. Nick
 
personally I wouldn't want to go on semaglutide, or any other medication, for the sake of a trial. If it's something I was going to do anyway I would jump at the opportunity because of all the checks and tests that you wouldn't normally get from your regular doc.
 
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