A Phase 1 interventional study of BioChaperone® Combo and Humalog® Mix25 in Type 2 Diabetes Mellitus, sponsored by Adocia. Completed at 2 sites in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-06-29.
Sponsored by Adocia · Phase 1, Interventional, and Treatment
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments.
During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Adocia is the lead sponsor of 26 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy
Drug: BioChaperone® Combo · Drug: Placebo
Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy
Drug: Humalog® Mix25 · Drug: Placebo
Individualised simultaneous subcutaneous injections
Drug: Humalog® · Drug: Lantus®
Injection of BioChaperone® Combo
Injection of Humalog® Mix25
Injection of Humalog®
Injection of Lantus®
Injection of 0.9% NaCl
Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)
Mean of incremental areas under the blood glucose concentration-time curve from 0-2 hours after a standardised meal on Day 2 and Day 3
Time frame: From 0 to 2 hours
Partial delta AUCs BG and total AUCs BG
Partial incremental AUCs BG and total AUCs BG in the 0-6 time range
Time frame: From 0 to 6 hours
Mean and mean change from baseline of blood glucose at different time points
Time frame: From 0 to 6 hours
Delta BGmax and delta BGmin
Maximum and minimum blood glucose excursions after a standardised meal
Time frame: From 0 to 6 hours
BGmax and BGmin
Maximum and minimum blood glucose concentrations after a standardised meal
Time frame: From 0 to 6 hours
AUC Insulin
Partial areas under the insulins plasma concentration time curve
Time frame: From 0 to 24 hours
Cmax Insulin
Maximum observed plasma insulins concentration
Time frame: From 0 to 6 hours
tmax Insulin
Time to maximum observed plasma insulins concentration
Time frame: From 0 to 6 hours
Adverse Events
Time frame: Up to 12 weeks (maximum duration of subject's participation)
Local tolerability
Time frame: Up to 12 weeks (maximum duration of subject's participation)
Hypoglycaemic events
Time frame: Up to 12 weeks (maximum duration of subject's participation)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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