Drugs Trial: injections for a non insulin type 2

[clairemm]

Anybody else been invited to take part in a new trial for type 2's on metformin? my dsn phoned me a few hours ago and said i met the criteria (on metformin and have hba1c of between 54 and 59 ((i think they were the numbers she quoted, pretty sure he 54 is right))
The trial will involve self administered injections once a week and then monthly check ups for a drug to control bg. shes sending me an info pack then has to give me a few days to decide but it sounds like if i say yes then i'm definitely on the trial.
I cant remember the name of the drug (she phoned me on my mobile and i was out and about doing ten things lol), it sounded like xenicol but it wasn't, because i doubled checked that and she said "nope that's a drug to aid weight loss, this is a drug to control blood sugars, but it may also help you lose weight" I was prescribed xenicol years ago and i would think long and hard before injecting that, the side effects were not fun.
anyway this request has got me interested and i will read the info carefully, it would be very easy to say i cant fit all the visits in round work, etc, but unless i really don't like something i read i think i'm going make myself do this and find a way to fit the visits in as and when i need to.

 

[Pumper_Sue]

Would this be it? http://www.dailymail.co.uk/health/a...-Bydureon-replaces-need-2-injections-day.html

 

[Redkite]

Could it be Bydureon? This is an injectable form of Byetta, currently being trialled. Do read the information very carefully before taking part - a quick google turned up the page below, which mentions that lab rats developed thyroid tumours, some cancerous, while receiving these injections.

http://www.bydureon.com

 

[clairemm]

Thanks, but i don't think it is Bydureon, as what ever the dsn did call it, it wasn't anything like that. it could of course just be a brand name for the same thing, but the first article say that Bydureon is to replace exenatide, and i'm not on that. i just take 2000mg metformin a day.

i will think about it carefully and find all the advice i can, but i really need to do something as I've just lost my dad to septic shock caused by diabetic ulcers and we thought he was bloody indestructible (very ill and very disabled, but ultimately immortal)

i've joined a gym and i work hard but the weight is just not moving, i've been told metformin doesn't stop you losing weight, but it doesn't help so my medication is not helping me with something i'm already rubbish at !! lol plus my dsn's keep telling me, and telling me, and telling me that i will never get off metformin and in fact they are nearly sure i will be on insulin within 5 years. and that's taking into account they are pleased with my progress and a big reduction in my bg figures. it just seems to be that's what they tell type 2's as standard these days. so maybe drastic action is the way to go.

 

[Copepod]

Usually with a study, potential people are identified by health professions already in contact and asked if they might be interested. If yes, details are passed to researchers, who will send more information, then arrange a meeting, where questions can be asked, and if all ok, a consent form signed. So, if you get written info, you'll be able to check true drug name, not just try to guess a part remembered name. Worth getting all info before deciding. In any case, you won't be allowed to sign up without being fully informed.

 

[PattiEvans]

Could it be Forxiga?

 

[clairemm]

right i have my info pack. the study is called Sustain 3 run by Novo Nordisk and the new drug is called Semaglutide.

798 (!!??) people in 10 different counties will be taking part. Half will be given Semaglutide and half will be given Bydureon (aka exenatide) on top of their normal medication. both drugs will be self administered once weekly.

The study last 61 weeks and during the course of the study each person will undergo: 59 injections, 2 questionnaires, 5 morning urine samples, upto 12 pregnancy tests, 10 weight and waist measurements, 11 bp and pulse checks, 4 electrocardiograms and have 12 sets of blood tests taken, as well as having to keep a diary of well being and medication.

i have 2 little books and an 18 page, 2 sided a4 file detailing all the tumours and side effects they don't think i'd develop 😱

its actually being run by my GP (in this country anyway i think, he's a big wig in one of these flagship 'health centre' and is a leading expert and head of lots of different things apparently , so lucky for me it would actually be my gp i would be meeting with and submitting data to, etc

i have to agree to meet a team, initial about 10 different declaration statements and an attend another 2 visits before i would even be given either of the drugs, so informed consent is a big part of it.

its a big commitment and a lot of time and visits, but when i said i lost my dad recently, i mean recently, his memorial is this Saturday. and he wouldn't have live the 66 years that he did without participating in some studies himself and benefiting from others having done them too, so i'm inclined to say yes, unless i get some responses i don't like to the list of questions i'm preparing.

 

[PattiEvans]

upto 12 pregnancy tests

No blokes on the study then?

 

[clairemm]

lol "upto" so i think they cover themselves with none is less than 12, surprised they allow women under 70 on study the amount of times it points out you can not be on this study while trying to, get or actually be, pregnant.

 

[PattiEvans]

Covering themselves methinks so that you can't sue if you do find out you're preggie because "You have been warned".

Do let us know how it goes.

 

[Lurch]

Hi ClaireMM.

This would give me a decision dilemma:

PRO:
1. (If in your shoes) it would be under my own GP, expert and all.
2. I'd be 'fussed over': poked, prodded and tested for 61 weeks in ways T2s don't get as a rule.
3. They'd not be free to test on humans if they hadn't tested on gerbils, mice or whatever they test first - would they not? Worth asking? - since posting, have found previous phase tested on humans...

http://www.medscape.com/viewarticle/803916_5

Extract: Another study looked at semaglutide at varying doses versus liraglutide or placebo in Type 2 diabetics in a 12-week, randomized, double-blind, placebo-controlled trial of 411 subjects with a mean A1c of 8.1%. Statistically significant dose-dependent reductions in A1c were seen at all doses of semaglutide ≥0.2 mg as compared with placebo. At higher doses ≥0.8 mg, more subjects reached target A1c <7% than with liraglutide at either 1.2 or 1.8 mg. Bodyweight was also reduced up to 4.8 kg vs placebo 1.2 kg (p < 0.01 for doses ≥ 0.8 mg). Nausea and vomiting were the most frequently cited adverse events. There were few reports of hypoglycemia in the semiglutide (n = 5) and liraglutide (n = 3) groups without episodes of major hypoglycemia.


4. I (ie. you) already know my control has proved tough. HBA1c between 54 and 59 mmol/mol is touching the 7.5% trigger (used in these parts anyway) to consider insulin therapy for T2s. So perhaps I'll benefit from more attention/intervention.

CON:
1. I'd be a 'test animal' for something entirely new. Side-effects and outcomes unknown.
2. I'm already struggling with control now, so I'd be giving a year+ to an untested drug intervention when maybe I should, if GP also thinks this, go the well-trodden/tested therapy route now and avoid losing a year? (Guess they can't risk taking those already on insulin off it to use them?).

Not sure what I'd decide. But, as you say, somebody has to be altruistic to participate in new drug trials. Rolling a dice with your health.

 

[clairemm]

hmm its interesting to see external data about side effects, they could become a pain, but if it gets too bad you come off the drug and they monitor you for a month or so after to get what data they can.

the info pack i have does say semaglutide has been tested on mice (mixed feelings about that) and Bydureon is a released form of treatment, so there has been varying levels of testing on both drugs

wish i could say it was altruistic but i think its more reckless/optimistic with a coating of selfish.
also going to request a a bit of give in return, i can participate if they will make the 'visits' (constantly called visits rather than appointments, i asked if that meant they come to me) with the doctor as he starts at 7am, the dsn's seem to work 1 till half past tuesday and wednesday!

 

[clairemm]

btw I'm on the trial now, I've had 2 injections so far. the injections are bloody complicated. involving a vial of powder, an 'adapter' you cant touch and a prefilled syringe and a lot of moves in-between. i had to film the nurse doing the demo (at 7am )
no sickness yet, but i now know what a hypo feels like, had to start carrying glucose tablets, which is something i didn't think me and my high scores would ever have to do.
still get high numbers (16 before having breakfast) but was in a devil may care mood this morning and had jam on my toast, then had a hypo 4 hours later!!