Date: 2013-11-13
Type of information: Interim results
phase: 1-2
Announcement: preliminary results
Company: Adocia (France)
Product: combination of insulin Glargine (Lantus®, Sanofi) with a fast-acting insulin analog, insulin Lispro (Humalog®, Eli Lilly)
Action mechanism:
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country: Germany
Trial
details: This clinical trial, conducted by Profil (CRO, Germany) was a double blind, two-way crossover study that enrolled 20 patients with type 1 diabetes under euglycemic clamp conditions. As part of the crossover design, all patients were treated with BioChaperone Combo and Humalog Mix 25 at the same dose of 0.8 IU/kg. The composition of BioChaperone Combo is based on 75/25 basal prandial ratio like in Humalog Mix 25. Pharmacokinetic (PK) and pharmacodynamic (PD) measurements were taken as patients were monitored for 30 hours after administration. The objective of the study was a comparison of pharmacodynamic (PD) and pharmacokinetic (PK) profiles of the combination of BioChaperone with Glargine/Lispro (75/25) to those of Humalog Mix 25. Safety and tolerability were also evaluated in this study.
Latest
news: * On February 27 2014, Adocia has announced positive preliminary results for the first clinical trial on an innovative formulation combining insulin analog Glargine (Lantus®, Sanofi), the gold standard basal insulin, with a rapid-acting insulin analog, Lispro (Humalog®, Eli Lilly) using Adocia's BioChaperone® technology. The objective of this trial was to show that this combination of the most widely used basal insulin (Lantus®) and one of the best commercial prandial insulins (Humalog®) formulated with the BioChaperone technology has the potential to help patients improve their blood glucose control more effectively than with a Premix formulation of insulin analog (Humalog Mix®, Lispro and Protamine).
The study demonstrated that BioChaperone Combo has the ability to deliver insulin with a faster onset and longer duration of action compared to Humalog Mix®:
- BioChaperone Combo had a greater than 30 per cent faster onset of action as compared to Humalog Mix.
- Almost all patients treated with BioChaperone Combo experienced a minimal duration of action in excess of 30 hours (end of monitoring).
- Both formulations of insulins (BioChaperone Combo and Humalog Mix®) were well tolerated.
The onset of action is the time when glucose level decreases by at least 5 per cent from the starting level and glucose infusion is started. Minimal duration of action is defined by the time when blood glucose concentration exceeds 6.5 mmol/L (118 mg/dL).
The PK profiles confirm these major conclusions based on PD profiles. The minimal duration of action in excess of 30 hours, support the use of the BioChaperone Combo as a once-a-day insulin treatment. This may provide patients with advantages over Premix formulations that usually require injection two or three times a day. BioChaperone Combo could also be used twice-a-day to support treatment intensification.
Adocia intends to publish a detailed analysis when the data become available in a few weeks. Adocia also intends to present the complete results at a major medical conference this year.
* On November 13, 2013, Adocia has announced that it has launched the first clinical trial of its formulation combining insulin Glargine (Lantus®, Sanofi) with a fast-acting insulin analog, insulin Lispro (Humalog®, Eli Lilly). This combination is based on the use of BioChaperone® technology developed by Adocia, which makes insulin glargine compatible with fast-acting insulin analogs.
This clinical trial aims to demonstrate that the combination could offer diabetic patients improved glycemic control compared to a Premix of insulin analog such as HumalogMix, based on insulin Lispro (Eli Lilly), or NovoMix®, based on insulin Aspart (Novo Nordisk). Hence, pharmacodynamic and pharmacokinetic profiles of the combination BioChaperone Glargine/Lispro will be compared to the pharmacodynamic and pharmacokinetic profiles of HumalogMix in a cross-over design on 20 Type I diabetic patients under a euglycemic clamp. The first patients of this double-blind study conducted in Germany have already been treated.
“There is a real need to provide patients using Lantus and a fast-acting insulin with the simplicity afforded by Premix products, as well as to offer Premix-using patients the greater medical efficacy obtained with Lantus, a real gold-standard,” said Gerard Soula, Adocia’s CEO. This combination could therefore extend Glargine’s market potential towards the Premix market. This Combo based on insulin Glargine, an insulin off-patent in 2015, has been internationally patented in 2012.”
Results from this study are expected during the first quarter of 2014.
