Off label update:
Ozemipic’s new indication, what does it mean for type 1 diabetes management?
There are two massive money makers in the pharmaceutical space these days, type 2 diabetes and Cardiovascular disease. With diabetes diagnosis rates climbing year after year, and heart disease being the number one cause of death in the US, this is not surprising. This population also typically overlaps. A major complication risk for people with diabetes is an increased risk for heart disease. Heart attack and heart failure rates are 4x higher in people with diabetes than the general public. Elevated blood sugars can cause triglyceride levels to rise in the blood, which can put us at higher risks for development of blockages and plaques in blood vessels, so blood sugar management is key. However, the two most popular and effective medications that we have used to treat high blood sugars have also carried side effects of the potential to increase heart disease risk (Specifically basal insulin and sulfonylureas). Finding medications that are not only heart disease risk neutral but can reduce heart disease risk is the ideal.
What are the 2 most popular and effective medications to treat high blood sugars that increase heart disease risk?
We have had an SGLT2 medication called Empaglifolozin.
This medication has had an indication to reduce heart failure in persons with Type 2 diabetes by reducing fluid volume retained in the body which also reduces blood pressure. This medication has also been a standout in the industry for having shown a reduction in repeated incidence in hospitalizations in people with established heart disease. Studies on most diabetes medications excluded participants with existing heart disease diagnoses and measured occurrences of new disease onset or events. But the Empagliflozin included persons with preexisting heart disease in their study data, and were this allowed an indication of not only preventing, but reducing occurrences of cardiovascular events.
We have also had liraglutide approved to reduce Heart disease risks.
However, Recently Novonordisk announced an additional indication for their GLP-1 medications Ozempic to “reduce the risk of major adverse cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.” This medication works by slowing gastric emptying which can reduce post prandial blood sugar spikes. Another helpful effect of this slowing is that we remain feeling full longer so it can help in weight management. Ozempic also stimulates insulin production to help maintain blood sugars in target range more effectively.
In 2019 we saw the FDA refuse to approve SGLT2 medications for people with type 1 diabetes due to DKA risk concerns, though this medication has been approved in the EU for years. GLP1 medications are also not indicated for use in the treatment of type 1 diabetes, however this medication can be helpful as people with Type 1 also have been shown to produce less of a hormone called incretins. This means that we often struggle with more rapid gastric emptying that can cause post meal blood sugars to rapidly climb. We also are more likely to struggle with increased appetite and reduced satiety due to these reduced incretin levels. As people with Type 1 we also may see an increased glucagon release after meals that we are not able to regulate leading to rapid post meal blood sugar spikes. GLP1 medications can offset these issues to help us keep post prandial blood sugars down.
An additional benefit for people with type 1 diabetes would be that reduced post prandial blood sugars can reduce total daily insulin use. This reduced insulin use combined with increase satiety can help us with weight management, a very complex struggle in Type 1 management.
Side effects of GLP-1 medications are primarily gastric, including nausea, diarrhea or constipation. These typically go away over a week or so at a steady dose and doses should be titrated up over months to avoid intense side effects. When starting these medications people with type 1 should expect digestion times to increase. This can be offset with using longer absorption times in Loop, using extended boluses on pumps, or splitting bolus doses with injection therapy. A reduction in bolus dose may also be needed.
Because these medications are not approved for use by persons with type 1 diabetes doctors may be hesitant to prescribe but approaching the conversation with education can help us partner with our prescribers well. Insurance companies may require a prior authorization from your prescriber.
The physiological truth is that diabetes is not black and white, type one or type 2. Most of us fall along the spectrum with type 1 with features of type 2 diabetes. So remaining open minded to the ability of medications for type 2 diabetes helping us manage type 1 can be really helpful.
I am a Type 1 diabetic and tested that my pancreas does not produce any insulin. I have been taking insulin for 34 years now and was curious to hear if Ozempic could be used for Type 1 DM. Thanks for your input.
Ozempic can be used off label for people with diabetes, we don’t get the insulin stimulation, but we can benefit from reduced hepatic glucose output and the digestive effects of the medication.
I have tried the ozempic and it works so well for me, It has lowered my A1C and i have lost weight, but due to guidelines put out there for type 1 diabetes, my insurance will not approve. I was on my husbands and he lost his job but his insurance paid. So now I am back to my sugar staying up around 180-240. I hate that insurance companies get to decide what is best for you!
if you can ask your doctor to prescribe it with a diagnosis code for obesity not for diabetes it (Or another GLP1) may get approved.
How do I go about finding an endo that will prescribe this off label for me. My current one will not and I’m not sure if anyone in my healthcare system will do this. I’d love to try it. The NP I see thinks it would good for me to try but she works under my doc how won’t let her prescribe it. My NP is even on it herself… it is so frustrating to not be able to advocate for myself. Where would we be in medicine if we didn’t use meds off label? So many drugs are used in many different ways from their original use
Hi Erica, First I recommend talking with your doctor about their specific reasons for not ordering this medication for you specifically. They may have good reasons that this medication is not a good fit. But if the NP thinks it is, they may just not be bothered with off label prescribing paperwork. unfortunately, at this point we just have to go “doctor shopping” when our prescribers are not on board. setting up a new patient appointment, asking around to others in your area who have more open minded doctors. You can also try your PCP or other specialists about prescribing a GLP1 as a weight loss medication, not even for your diabetes.
I am type 1 for 7 years diagnosed at age 57. I wear a Medtronic’s pump and sensor (a story in itself). I asked my dr about ozempic because I have had such a hard time losing any weight since diagnosis. I’m on my 3rd week. I’ve lost some weight but the side effects are horrible. 0 appetite for 3-4 days, heartburn and exhausted. I have to decide by Friday (next injection) whether to continue. Just not sure it is worth it. All of diabetes suck!
Ozempic is not right for everyone, sounds like your dose is definitely too high. You can bolus to the doses in between those marked on the Ozempic pen. You also might benefit from a different GLP1 like Victoza.
Hi Marcy,
Thanks for sharing. I am a TYPE 1 diabetic for 24 years and use the medtronic pump and sensor as well. I have read that this medication is only for Type 2 diabetics. Have your blood sugars improved? I am sorry to hear of all of your side effects.
You can definitely be type 1 and type 2 at the same time. Type2 is insulin resistance. And I know everyone can have varying amounts of insulin resistance but it’s not the same thing. When my sugar is high my resistance is higher.
I am type 1 I use about 55 units of insulin per day by pump. 30 basal 25 bolus. But when I’m sick or my sugar is high, I can use up 80 in one day.
To know if you are type2 there is a simple calculation. You should be using 0.5 to 0.8 units of insulin per kilogram of weight per day. If you are using more than that , you are likely insulin resistant and type 2, weather or not you are also type 1. It’s not so easy to calculate for someone who is just type2, but the numbers correlate to c peptide results, so you can see it in those results, which is how most type 2 are diagnosed
I weigh 90 kilos so I’m 198 lbs at 6’3 I’m high end of normal weight. I should be using 45-70 units per day according to this formula. Since I’m using 55, I’m generally not considered insulin resistant.
So if I was consistently in the 80 units per day range, I could make a case to get ozempic . If you are out of range I think think your doctor will at least consider trying Ozempic
Spot on Tim, there is no line between types 1 and 2 (no matter what insurance companies try to impose) these medications can be super helpful for many who’s “diagnosis” may not be as simple as the paperwork makes it look.
Misdiagnosed as a Type 2 and given Ozempic. I only needed 10u of Lantus and would bolus 1u:30g. Blood work came back with a new endocrinologist and I’m T1/LADA and now insurance will not cover Ozempic. Switched to an insulin pump and taking 30-35u basal and my insulin to carb ratio went from 1u:30g to 1u:15g with exercise and 1:9 without exercising.
Never experienced DKA/HHS while doing MDI with Ozempic. I have gone into DKA with insulin pump, but insurance and shipping delays led to insecurity with an insulin pod and expired Lantus from pre-pump era didn’t save me.
Side effects of Ozempic seemed no different than side effects of insulin usage after the first 4 days. However, Ozempic greatly reduced desire to eat and enable a consistent MDI schedule which greatly improved my A1C.
I honestly liked being diagnosed as T2 for access to Ozempic. An insulin pump is nice, but I really dislike the constant hunger and increased insulin demands.
I’m with you Jonathan,
the arbitrary determinations of insurance companies should never be allowed to override the doctor’s authority and prescribing choices.
Your doctor can do an appeal to get Ozempic (Or another GLP1 covered)
I had my first appt with a new endo 3 weeks ago. Have been Type 1 for 24 years. Was having to use much more insulin in the last couple of years and having all kinds of issues with highs late hours after my last meal. The Dr gave me a sample of Ozempic and I’ve been taking it since. I have greatly reduced my insulin and my blood sugars are almost always perfect with an occasional high but nothing like my highs before. I haven’t seen anything over 200 since I started this medicine. I also have complexly lost my appetite and have to force myself to eat just to not feel weak. The first couple of weeks I had lots of lows so I didn’t lose any weight but since reducing my insulin and getting the dose right I have lost at least 5 pounds. I do have headaches, nausea, heartburn and dizziness. Those symptoms are getting a little better. I have read that if you give the shot in your stomach the nausea is worse and that is where I was getting it. I have no idea if my insurance will cover this but i will take it if they do.
Thanks so much for sharing your experience Alisha
if insurance doesn’t cover it well ask what other GLP1 medications are on their formulary, they usually have a preferred brand that will be cheaper, then reach out tot he prescriber for a discount card to get the price down more.
Where do you give yourself your Ozempic shot?
We can use any subcutaneous fat layer with more than 6 mm of fat, just remember to keep it spaced at least 2 inches from any insulin injection site used that day or from your infusion set or CGM.
There has been some data showing improved effect of GLP-1 medications like Ozempic and reduced side effects when injected in the abdominal fat layer. But it also depends on how well injections absorb in the abdomen (Since many of we long time insulin users have accumulated more scar tissue on our abdomens from less than stellar rotation habits in the past)
Hi all my fellow type 1 diabetes
sufferers. I have wonderful news. I am 32 year old female no children I have type 1 since age 16 insulin dependent can not afford a pump, I have graves disease, hyperthyroidism and polycystic ovarian syndrome. I have been about 25 kilos over weight my entire life, constantly struggled with diabulimia and losing weight. I gave up 2 years ago and at my heaviest this year I was 84 kilos. My endo decided to put me on ozempic. I have been using it once a week for two months and I have lost a total of 13 kilos. I now weigh 70 kilos and my goal weight is not far.Type 1 this is VERY safe to use under the supervision of an endo.
DO IT
IT WILL CHANGE YOUR LIFE
Thanks for sharing your experience Jaxon.
Just a note to please take care for comments online to not sound like you’re giving medical advice because while GLP1s can be hugely beneficial for some, they’re not the right fit for everyone.
but definitely work with your providers!
Alicia could you Please clarify something – if its not approved cor type one then what good will it do to discuss this with my Doctor? To be clear i am a tyoe 1. Is there still an option for my Doctor to prescribe it?
HI Danny,
yes, doctors can do what is called “off label prescribing” it may require a prior authorization to get insurance to approve it, but they can still write the Rx
I happen to be Type 1.5, or “double diabetic”, myself. I am Type 1 insulin dependent, diagnosed at 24. However, I am also severely insulin resistant with the metabolic syndrome of most Type 2’s. There really is no black & white with diabetes as was believed for so long. For instance, steroids will raise blood sugar, so most doctors try not to use them on diabetics if they can help it. For myself, however, my blood sugar runs low for the week I’m on a steroid dose pack. My doctor claims I’m her troublemaker problem patient because my diabetes is unpredictable and doesn’t usually follow the “norm”.
HI Jenny, I say the “norm” is over rated :)
most of us really live somewhere between “pure” type 1 and “pure” type 2. there are people with type 1 who have insulin resistance of all degrees, and there are people with type 2 who have impaired pancreatic functioning for any number of reasons. The only difference in diagnosis really is the presence of antibodies, but the treatment and how we live with it is as individual as the people themselves! NO Problem patients, just people who live a little farther outside of the “box” than others!
The sentence about falling on the spectrum of type 1 is offensive. If you knew anything about type 1 and type 2 you should know they are similar but different. You should never say you are a type 1 that had type 2 features. There is no you have type 1 with type 2 features. It’s called having diabetes. Type 1 and type 2 are very similar in the way they can act. For example type 2s are not the only ones who are insulin resistant that’s everyone. I’m a type 1 and don’t buy into this article because I have Diabetes. I know I’m type 1 and nothing else. I know others who have type 2 and taking care of themselves might be different but they are still managing a different form of diabetes. So ignorant.
Actually Kyle as both a person with diabetes and a clinician I have to disagree entirely. However because I disagree from a clinical as well as psycho social point of view I will not assume you are ignorant, simply approaching the topic from a very different view point. There are dozens of different causes, forms and variations of diabetes (that we even know of) and a lot of different ways of identifying, nd referring to places of overlap.
Type 1 or Type 2 is more to do with the primary causing element, not the active treatment. As an example, a T2 could be entirely insulin dependent in the same manner as a T1. Additionally, insulin resistance (a primary feature of T2) can be observed in T1 patients. Additionally, there are more types of diabetes than T1 and T2: GI, LADA, MODY, T3c, etc. Diabetes is complicated.