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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562326
• Other study ID #: BC3-CT014
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2015
• Last updated: April 28, 2016
• Start date: September 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• BioChaperone insulin lispro
Injection immediately before the start of the individualised standard meal
• Humalog®
Injection immediately before the start of the individualised standard meal

Locations

Country	Name	City	State
Germany	Profil Mainz GmbH & Co.KG	Mainz
Germany	Profil GmbH	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Adocia	Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics: ?AUCBG 0-2h	Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro)	2 hours	No
Primary	Pharmacokinetics: AUClis 0-30min	Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro)	30 minutes	No
Secondary	AUClisp_0-6h	Area Under the serum insulin Lispro concentration-time Curve from 0-6 hours after bolus dose	up to 6 hours	No
Secondary	Cmax_lisp	Maximum serum insulin lispro Concentration	up to 6 hours	No
Secondary	tmax_lisp	Time to maximum observed serum insulin lispro concentration	up to 6 hours	No
Secondary	CmaxBG	Maximum Blood Glucose after an individualised standard meal	up to 6 hours	No
Secondary	AUCBG_0-6h	Area Under the Curve under the Blood Glucose concentration time curve from 0-6 hours	up to 6 hours	No
Secondary	Adverse Events	Number of Adverse Events	up to 8 weeks	Yes
Secondary	Local tolerability	Record of injection site reaction	up to 8 weeks	Yes