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Post by jpg on Oct 27, 2015 14:47:36 GMT -5
interesting. the blood laboratory results of some require both cholesterol lowering as well as better blood glucose control. The drug is interesting as well. Take a look. The recommended starting dose of PRALUENT is 75 mg administered subcutaneously once every 2 weeks, Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. 7
Maybe they already have evidence that Afrezza (through an internal study) has a direct effect on metabolic syndrome, but are using Afrezza as "just another diabetes drug" for now since there is nothing known to the FDA about this benefit. As such, they're piggy backing on Afrezza to show better results of Praluent. Long shot, I know. I do not think this is a long shot. I think this is the end goal.
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Post by peppy on Oct 27, 2015 17:44:39 GMT -5
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Post by jgv on Oct 28, 2015 1:56:50 GMT -5
Maybe they already have evidence that Afrezza (through an internal study) has a direct effect on metabolic syndrome, but are using Afrezza as "just another diabetes drug" for now since there is nothing known to the FDA about this benefit. As such, they're piggy backing on Afrezza to show better results of Praluent. Long shot, I know. I do not think this is a long shot. I think this is the end goal. DM is an intricate component of metabolic syndrome which leads to nonalcoholic steatohepatitis (NASH). NASH is an epidemic and quickly becoming a leading cause for cirrhosis and liver transplants. They are using Afrezza for a reason. I guarantee it!
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Post by jpg on Oct 28, 2015 2:11:38 GMT -5
I do not think this is a long shot. I think this is the end goal. DM is an intricate component of metabolic syndrome which leads to nonalcoholic steatohepatitis (NASH). NASH is an epidemic and quickly becoming a leading cause for cirrhosis and liver transplants. They are using Afrezza for a reason. I guarantee it! Agreed this could certainly be one possible therapeutic target and simply decreasing the incidence of NASH mildly would be a huge therapeutic win. As we all seem to agree Afrezza could be an interesting part of metabolic syndrome management.
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Post by peppy on Oct 29, 2015 14:46:27 GMT -5
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Post by compound26 on Nov 4, 2015 10:59:48 GMT -5
Credit: fofos2000 Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) www.clinicaltrials.gov/ct2/show/NCT02585778Hi, members, do you know if the use of Afrezza by any of the participants in this study will be included in the prescription count? I don't know how this works. If it is, could it be that on one of those weeks, we will see our scripts jump a few hundreds because of this study? The study is supposed to start in October. Could it be this Friday or next Friday? blindhog1, you probably can shed some light on this since you are being included in a study.
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Post by jpg on Nov 4, 2015 11:11:03 GMT -5
Credit: fofos2000 Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) www.clinicaltrials.gov/ct2/show/NCT02585778Hi, members, do you know if the use of Afrezza by any of the participants in this study will be included in the prescription count? I don't know how this works. If it is, could it be that on one of those weeks, we will see our scripts jump a few hundreds because of this study? The study is supposed to start in October. Could it be this Friday or next Friday? blindhog1, you probably can shed some light on this since you are being included in a study. Recruitment is dome over weeks and months so no instant pop.
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Post by compound26 on Nov 4, 2015 11:13:30 GMT -5
Hi, members, do you know if the use of Afrezza by any of the participants in this study will be included in the prescription count? I don't know how this works. If it is, could it be that on one of those weeks, we will see our scripts jump a few hundreds because of this study? The study is supposed to start in October. Could it be this Friday or next Friday? blindhog1, you probably can shed some light on this since you are being included in a study. Recruitment is dome over weeks and months so no instant pop. No instant pop is fine. If the participants' consumption is included in the prescription count, that still helps.
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Post by rrtzmd on Nov 4, 2015 11:53:54 GMT -5
Credit: fofos2000 Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) www.clinicaltrials.gov/ct2/show/NCT02585778Hi, members, do you know if the use of Afrezza by any of the participants in this study will be included in the prescription count? I don't know how this works. If it is, could it be that on one of those weeks, we will see our scripts jump a few hundreds because of this study? The study is supposed to start in October. Could it be this Friday or next Friday? blindhog1, you probably can shed some light on this since you are being included in a study. "...will be included in the prescription count? No. The drugs will be distributed by the company. They will be counted and logged with each distribution, where any changes in dosages will take place as well. Sanofi will probably also require participants to retain their used cartridges in order to insure that there has not been any diversion of the drug elsewhere.
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Post by peppy on Nov 4, 2015 12:05:31 GMT -5
Hi, members, do you know if the use of Afrezza by any of the participants in this study will be included in the prescription count? I don't know how this works. If it is, could it be that on one of those weeks, we will see our scripts jump a few hundreds because of this study? The study is supposed to start in October. Could it be this Friday or next Friday? blindhog1, you probably can shed some light on this since you are being included in a study. "...will be included in the prescription count? No. The drugs will be distributed by the company. They will be counted and logged with each distribution, where any changes in dosages will take place as well. Sanofi will probably also require participants to retain their used cartridges in order to insure that there has not been any diversion of the drug elsewhere. This makes sense to me. Mannkind makes Afrezza, Sanofi buys it from Mannkiond. Mannkind can not book the sale of Afrezza until Sanofi sells it. (Is what I think I read.) On the bright side, the increase in scipts and refills are from users other than studies.
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Post by jpg on Nov 4, 2015 12:27:53 GMT -5
Study drugs /participants do not count as prescriptions.
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Post by fofos2000i on Mar 11, 2016 5:13:30 GMT -5
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Post by peppy on Mar 11, 2016 7:15:07 GMT -5
Primary Objectives: •To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in patients with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. •To evaluate the safety and tolerability of alirocumab in patients with diabetes treated with insulin. Secondary Objective: To demonstrate that alirocumab is superior in comparison to placebo in its effects on other lipid parameters (ie, measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C], apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)]), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) levels, triglyceride rich lipoproteins (TGRL), apolipoprotein A-1 (Apo A-1), apolipoprotein CIII (Apo C-III), and LDL particle number and size). Detailed Description The maximum study duration will be approximately 9 months per patient, including a 6 month treatment period, a screening period of up to 3 weeks, and an 8 week safety observation period.
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Post by agedhippie on Mar 11, 2016 13:26:14 GMT -5
Sanofi cannot terminate the trial without breaking the partnership agreement. The cost for the trial passes to Mannkind once the split happens but Sanofi will have paid for most of the recruitment phase which is expensive.
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Post by kc on Mar 11, 2016 14:32:41 GMT -5
Sanofi cannot terminate the trial without breaking the partnership agreement. The cost for the trial passes to Mannkind once the split happens but Sanofi will have paid for most of the recruitment phase which is expensive. This was not MannKind's study. It was Sanofi and Regeneron. It will be interesting to see how the study plays out. Would it be funny or ironic if Regeneron ends up with MannKind? They are cash rich and could really benefit from Technosphere. The would know what to do with the development of Technosphere and also how to market Afrezza. Yes! I know that Sanofi owns about 15 to 20% of Regeneron. Maybe the Sanofi had to kill the partnership with MannKind to allow Regeneron to take a stake or buy MannKind? Pure speculation but who really knows other than MannKind, Sanofi and Regeneron?
Trial information: This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Sanofi
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Further study details as provided by Sanofi:
Primary Outcome Measures: •Percent change in calculated LDL-C in the intent to treat (ITT) population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
•Number of patients with adverse events [ Time Frame: From baseline to Week 32 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures: •Percent change in calculated LDL-C in the modified ITT (mITT) population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
•Percent change in measured LDL-C in the ITT population [ Time Frame: From baseline to Weeks 12 and 24 ] [ Designated as safety issue: No ]
•Percent change in calculated LDL-C in the ITT population [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
•Percent change in non-HDL-C in the ITT population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
•Percent change in Apo B in the ITT population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
•Percent change in total cholesterol in the ITT population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
•Proportion of patients reaching calculated LDL-C < 70 mg/dL in the mITT population [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
•Proportion of patients reaching calculated LDL-C < 50 mg/dL in the mITT population [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
•Proportion of patients reaching non-HDL < 100 mg/dL in the mITT population [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
•Proportion of patients reaching non-HDL < 80 mg/dL in the mITT population [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
•Percent change in Lp(a) in the ITT population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
•Percent change in HDL-C in the ITT population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
•Percent change in TG in the ITT population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
•Percent change in LDL-C particle number in the ITT population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
•Percent change in LDL-C particle size in the ITT population [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
Estimated Enrollment: 500 Study Start Date: October 2015 Estimated Study Completion Date: February 2017 Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure) Information provided by (Responsible Party):
Sanofi
Assigned Interventions
Experimental: Alirocumab Will be injected subcutaneously every 2 weeks starting with Dose 1 with potential blinded uptitration to Dose 2 at Week 12. The following background therapies: antihyperglycemic agents, statins, and other lipid modifying therapy will be administered as applicable or as per Investigator's discretion Drug: ALIROCUMAB SAR236553 (REGN727) Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: Praluent Drug: insulin Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: Lantus (insulin glargine) Drug: insulin Pharmaceutical form:powder Route of administration: inhalation
Other Name: Afrezza (insulin human) Drug: statin Pharmaceutical form:tablet Route of administration: oral Drug: lipid modifying therapy Pharmaceutical form:tablet Route of administration: oral Placebo Comparator: Placebo Will be injected subcutaneously every 2 weeks. The following background therapies: antihyperglycemic agents, statins, and other lipid modifying therapy will be administered as applicable or as per Investigator's discretion Drug: placebo Pharmaceutical form:solution for injection Route of administration: subcutaneous Drug: insulin Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: Lantus (insulin glargine) Drug: insulin Pharmaceutical form:powder Route of administration: inhalation
Other Name: Afrezza (insulin human) Drug: statin Pharmaceutical form:tablet Route of administration: oral Drug: lipid modifying therapy Pharmaceutical form:tablet Route of administration: oral
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