Clinical trial NCT02562326: A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
Official title: A Randomised, Monocentric, Double-blind, Multiple Daily Dose, Two-period 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualised Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2015-09-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days. Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be determined at the screening visit. During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason). They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus ≥ 12 months
* Treated with stable multiple daily insulin ≥ 3 months (basal-bolus therapy or only bolus insulin therapy)
* Current total daily insulin treatment \<1.2 (I)U/kg/day
* Body Mass Index below or equal to 40.0 kg/m²
* HbA1c ≤ 9.0% by local laboratory analysis

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Type 1 diabetes mellitus
* Previous participation in this trial
* The receipt of any investigational product within 60 days prior to this trial
* Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator
* Presence of renal impairment (Estimated Glomerular filtration Rate (eGFR)\<60 milliliters/minute/1.73m²)
* Presence of late diabetic complications and/or acute coronary heart disease.
* Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption
* Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial
* Current treatment with corticosteroids

Primary outcomes:
measure: Pharmacodynamics: ΔAUCBG 0-2h
timeFrame: 2 hours
measure: Pharmacokinetics: AUClis 0-30min
timeFrame: 30 minutes
Secondary outcomes:
measure: AUClisp_0-6h
timeFrame: up to 6 hours
measure: Cmax_lisp
timeFrame: up to 6 hours
measure: tmax_lisp
timeFrame: up to 6 hours
measure: CmaxBG
timeFrame: up to 6 hours
measure: AUCBG_0-6h
timeFrame: up to 6 hours
measure: Adverse Events
timeFrame: up to 8 weeks
measure: Local tolerability
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Profil Mainz GmbH & Co.KG
city: Neuss
country: Germany
facility: Profil GmbH
Study officials:
affiliation: Profil GmbH
name: Grit Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: