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VijithRoy ☆ India, 2021-06-27 08:49 (1026 d 10:31 ago) Posting: # 22435 Views: 1,754 |
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Hello all, I currently work on Insulin clamp BE study. It's a two period cross over double blinded study. Recently, i noticed the Glucose infusion rate (GIR) vs time (hr) graph of one subject which reflected the neat graph (i.e, on set of action was in range), where as the period II of the same subject showed zero GIR or onset of action was out of the normal range. The same case I found in more than 2 subject. If in case of treatment effect(A/B), I also noticed both (A/B) gave proper Tmax &Cmax for other subjects. What might be the possible reasons (eg_intrasubject variation, T/R, formulation etc,.) for Significant no action in GIR compared to period 1? Thanks, Vijit. — With Best Regards, Vroy. |
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ElMaestro ★★★ Denmark, 2021-06-27 12:02 (1026 d 07:17 ago) @ VijithRoy Posting: # 22436 Views: 1,444 |
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Hi Vijith Roy, ❝ I currently work on Insulin clamp BE study. It's a two period cross over double blinded study. Recently, i noticed the Glucose infusion rate (GIR) vs time (hr) graph of one subject which reflected the neat graph (i.e, on set of action was in range), where as the period II of the same subject showed zero GIR or onset of action was out of the normal range. The same case I found in more than 2 subject. ❝ ❝ If in case of treatment effect(A/B), I also noticed both (A/B) gave proper Tmax &Cmax for other subjects. ❝ ❝ What might be the possible reasons (eg_intrasubject variation, T/R, formulation etc,.) for ❝ Significant no action in GIR compared to period 1? Zero GIR would suggest the existence of some technical issue or possibly an erroneous insulin. You may have a range of other measures which indicate if the subject is producing insulin and/or other metabolic indicators of normal and abnormal function. There is so little detail in your description that I can't suggest much. I hope you will give lots of more info, show primary and secondary endpoint tables etc. — Pass or fail! ElMaestro |
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msmnainar ★ India, 2021-06-28 17:08 (1025 d 02:12 ago) @ ElMaestro Posting: # 22437 Views: 1,452 |
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Hi Vijith Roy, In addition to technical issue, it may be population related issue too. Some of the Clamp study its expected to see non-responders, especially in Type 1 Diabetes mellitus patients, due to complete absence of insulin. What about PK, did you observed any concentration in that subjects? Thanks Sundar. M — Sundar. M |
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VijithRoy ☆ India, 2021-06-30 08:39 (1023 d 10:41 ago) @ msmnainar Posting: # 22439 Views: 1,347 |
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❝ Dear Sundar, ❝ Some of the Clamp study its expected to see non-responders, especially in Type 1 Diabetes mellitus patients, due to complete absence of insulin. This study is conducted only on healthy subject. Before we enroll each subjects we screen them (Glucose Tolerance Test), so that we ensure no insulin resist subject comes in to the study. ❝ What about PK, did you observed any concentration in that subjects? — With Best Regards, Vroy. |
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msmnainar ★ India, 2021-07-01 16:14 (1022 d 03:05 ago) @ VijithRoy Posting: # 22447 Views: 1,332 |
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Hi, Other options you can explore, corresponding C-peptide data, if measured Cross-verify the GL data that is generated for Clamp validation during clamp period, if available — Sundar. M |
Ing. Helmut Schütz