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Clinical · Special populations

Type 1 diabetes: off-label use and the evidence gap — what changed since

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Solved by z.szabo in post #3
On the opening post — agreed on the reasoning, with one qualification. Gastroparesis: pre-existing severe delayed gastric emptying can worsen with compounds that slow it further. Discussion with a clinician is prudent if this history exists.

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SO
s.ostergaardTL2 Moderator18 Nov 2024#1

Type 1 diabetes: off-label use and the evidence gap — what changed since — setting out what I have, and where I think it stops being reliable.

Asking about a population rather than about a person.

The published trials in this class mostly enrolled a fairly specific group, and the questions here frequently come from people well outside it. I would like to understand what the honest position is when someone falls outside the studied population: not "it is fine" and not "there is no data", but what the reasoning actually looks like.

19 likes 20mo
KR
k.redgraveTL2Member18 Nov 2024#2

Picking up the opening post: that is the part I would want checked first.

For anyone arriving from a search: the marked solution above is the direct answer, and the replies underneath it add the caveats that make it safe to use.

3 likes 20mo
ZS
z.szaboTL2 Moderator Solution18 Nov 2024 · edited#3

On the opening post — agreed on the reasoning, with one qualification.

Gastroparesis: pre-existing severe delayed gastric emptying can worsen with compounds that slow it further. Discussion with a clinician is prudent if this history exists.

7 likes 20mo
NT
nl_translatorTL2Translator · NL18 Nov 2024#4

Pregnancy and planning: these compounds are not approved for use in pregnancy. Planning windows (how long to wait before attempting pregnancy) are not formally established. Conservative approaches wait several months to allow clearance.

1 like 20mo
SD
s.demirTL2 Moderator19 Nov 2024#5

Having read the exchange above, I think I was wrong earlier in this topic and I want to say so plainly rather than quietly editing.

The correction was fair and I had been repeating something I had not checked carefully enough.

6 likes 20mo
C
CFairweatherTL1Member19 Nov 2024#6
s.demir, post #5: Having read the exchange above, I think I was wrong earlier in this topic and I want to say so plainly rather than quietly editing. The correction was fair and I had been repeating something I had not checked carefully enough. Go to post

Pancreatitis history: the compounds can rarely trigger pancreatitis. A history of pancreatitis makes monitoring for recurrence more important during titration.

1 like in reply to #5 20mo
AC
a.cabreraTL2 Moderator19 Nov 2024#7
nl_translator, post #4: Pregnancy and planning: these compounds are not approved for use in pregnancy. Planning windows (how long to wait before attempting pregnancy) are not formally established. Conservative approaches wait several months to allow clearance. Go to post

Worth separating two things that post #3 runs together.

Adolescents: a distinct evidence base exists. The compounds are not approved for routine adolescent obesity but are being studied. Adolescent physiology and psychology differ from adults' in ways that matter for this medication class.

0 likes in reply to #4 20mo
CP
citation_peakTL3Regular19 Nov 2024#8

post #7 is right about the mechanism and I think understates the practical bit.

Medullary thyroid carcinoma history: an absolute contraindication because of the preclinical findings in rodent toxicology. The history (personal or family, especially multiple endocrine neoplasia type 2) is an important screening question.

22 likes 20mo
IL
i.lehtinenTL2 Moderator19 Nov 2024#9
a.cabrera, post #7: Worth separating two things that post #3 runs together. Adolescents: a distinct evidence base exists. The compounds are not approved for routine adolescent obesity but are being studied. Adolescent physiology and psychology differ from adults' in ways that matter for this medication class. Go to post

Coming back to post #7, because the follow-up matters more than the original answer.

Renal impairment: the compounds are cleared renally to some degree. Dose adjustments might be needed in severe renal impairment. Consulting with a clinician familiar with renal dosing is prudent.

0 likes in reply to #7 20mo
QZ
q.zhao_qaTL3Quality assurance19 Nov 2024 · edited#10

Hepatic impairment: less is known about dosing in significant liver disease than in kidney disease. Extreme caution applies because the liver metabolises a large fraction of many medications.

29 likes 20mo
PK
p.krastevTL2 Moderator19 Nov 2024#11

Picking up post #8: that is the part I would want checked first.

Disordered eating history: a history of anorexia nervosa, bulimia, or other eating disorders changes the risk-benefit calculation because appetite suppression might trigger relapse. This population requires specialist input.

7 likes 20mo
V
VPoulsenTL3Regular20 Nov 2024#12
s.ostergaard, post #1: Type 1 diabetes: off-label use and the evidence gap — what changed since — setting out what I have, and where I think it stops being reliable. Asking about a population rather than about a person. The published trials in this class mostly enrolled a fairly specific group, and the questions here frequently come from people well outside… Go to post

Coming back to post #10, because the follow-up matters more than the original answer.

Two things before anyone answers the substance.

First, the context in the first post is clear and specific. Second, the question is framed so that an answer can actually address it. Both are the norm here and both matter more than they sound.

18 likes in reply to #1 20mo
FD
f.danquahTL2 Moderator20 Nov 2024 · edited#13

Hypoglycemia risk: in people already on insulin or sulfonylureas, adding a GLP-1 agonist requires insulin dose reduction and close monitoring for hypoglycemia. This is manageable with attention.

0 likes 20mo
CC
crossref_checkTL3Wiki editor20 Nov 2024#14

Hepatic impairment: less is known about dosing in significant liver disease than in kidney disease. Extreme caution applies because the liver metabolises a large fraction of many medications.

0 likes 20mo
SG
s.girardTL2 Moderator20 Nov 2024 · edited#15

This follows post #12 rather than contradicting it.

Medullary thyroid carcinoma history: an absolute contraindication because of the preclinical findings in rodent toxicology. The history (personal or family, especially multiple endocrine neoplasia type 2) is an important screening question.

4 likes 20mo
CO
c.okaforTL3Regular20 Nov 2024#16

Gastroparesis: pre-existing severe delayed gastric emptying can worsen with compounds that slow it further. Discussion with a clinician is prudent if this history exists.

12 likes 20mo
AI
a.ilungaTL2 Moderator20 Nov 2024#17
a.cabrera, post #7: Worth separating two things that post #3 runs together. Adolescents: a distinct evidence base exists. The compounds are not approved for routine adolescent obesity but are being studied. Adolescent physiology and psychology differ from adults' in ways that matter for this medication class. Go to post

For anyone arriving from a search: the marked solution above is the direct answer, and the replies underneath it add the caveats that make it safe to use.

26 likes in reply to #7 20mo
LE
logbook_erinTL3Regular20 Nov 2024#18

Older adults: sarcopenia risk is higher, polypharmacy is common, and the clinical trials did not enroll many people over 75. Extrapolating to very old people is extrapolating beyond the data.

0 likes 20mo
MN
m.nascimentoTL2 Moderator20 Nov 2024#19

Pancreatitis history: the compounds can rarely trigger pancreatitis. A history of pancreatitis makes monitoring for recurrence more important during titration.

2 likes 20mo
CL
coldchain_liuTL3Regular20 Nov 2024#20

Pregnancy and planning: these compounds are not approved for use in pregnancy. Planning windows (how long to wait before attempting pregnancy) are not formally established. Conservative approaches wait several months to allow clearance.

8 likes 20mo
CR
c.ramosTL2 Moderator21 Nov 2024 · edited#21
VPoulsen, post #12: Coming back to post #10, because the follow-up matters more than the original answer. Two things before anyone answers the substance. First, the context in the first post is clear and specific. Second, the question is framed so that an answer can actually address it. Both are the norm here and both matter more than they sound. Go to post

Coming back to post #19, because the follow-up matters more than the original answer.

Adolescents: a distinct evidence base exists. The compounds are not approved for routine adolescent obesity but are being studied. Adolescent physiology and psychology differ from adults' in ways that matter for this medication class.

6 likes in reply to #12 20mo
JC
j.castellanosTL2 Moderator21 Nov 2024#22

For anyone arriving from a search: the marked solution above is the direct answer, and the replies underneath it add the caveats that make it safe to use.

1 like 20mo
JS
j.sorensenTL2 Moderator21 Nov 2024#23

Renal impairment: the compounds are cleared renally to some degree. Dose adjustments might be needed in severe renal impairment. Consulting with a clinician familiar with renal dosing is prudent.

31 likes 20mo
CR
c.rasmussenTL2 Moderator21 Nov 2024#24

post #23 answers the question as asked. The question underneath it is different.

Disordered eating history: a history of anorexia nervosa, bulimia, or other eating disorders changes the risk-benefit calculation because appetite suppression might trigger relapse. This population requires specialist input.

16 likes 20mo
MA
m.adeyemiTL2 Moderator21 Nov 2024#25
c.okafor, post #16: Gastroparesis: pre-existing severe delayed gastric emptying can worsen with compounds that slow it further. Discussion with a clinician is prudent if this history exists. Go to post

Hypoglycemia risk: in people already on insulin or sulfonylureas, adding a GLP-1 agonist requires insulin dose reduction and close monitoring for hypoglycemia. This is manageable with attention.

10 likes in reply to #16 20mo
C
chromatogramTL4Analytical chemist21 Nov 2024#26
p.krastev, post #11: Picking up post #8: that is the part I would want checked first. Disordered eating history: a history of anorexia nervosa, bulimia, or other eating disorders changes the risk-benefit calculation because appetite suppression might trigger relapse. This population requires specialist input. Go to post

Renal impairment: the compounds are cleared renally to some degree. Dose adjustments might be needed in severe renal impairment. Consulting with a clinician familiar with renal dosing is prudent.

3 likes in reply to #11 20mo
AW
a.wikstromTL2 Moderator21 Nov 2024#27

Worth separating two things that post #23 runs together.

Hypoglycemia risk: in people already on insulin or sulfonylureas, adding a GLP-1 agonist requires insulin dose reduction and close monitoring for hypoglycemia. This is manageable with attention.

0 likes 20mo
JM
j.mwangiTL4 Moderator21 Nov 2024#28
Staff post. Actions described here are recorded in the public moderation log and may be challenged in Meta.

post #27 is right about the mechanism and I think understates the practical bit.

Disordered eating history: a history of anorexia nervosa, bulimia, or other eating disorders changes the risk-benefit calculation because appetite suppression might trigger relapse. This population requires specialist input.

22 likes 20mo
HK
h.koodziejTL2Member21 Nov 2024#29

Gastroparesis: pre-existing severe delayed gastric emptying can worsen with compounds that slow it further. Discussion with a clinician is prudent if this history exists.

15 likes 20mo
EM
e.mwangiTL2 Moderator22 Nov 2024#30
nl_translator, post #4: Pregnancy and planning: these compounds are not approved for use in pregnancy. Planning windows (how long to wait before attempting pregnancy) are not formally established. Conservative approaches wait several months to allow clearance. Go to post

Medullary thyroid carcinoma history: an absolute contraindication because of the preclinical findings in rodent toxicology. The history (personal or family, especially multiple endocrine neoplasia type 2) is an important screening question.

6 likes in reply to #4 20mo