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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

NCT ID: NCT02562326

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BioChaperone insulin lispro

Group Type EXPERIMENTAL

BioChaperone insulin lispro

Intervention Type DRUG

Injection immediately before the start of the individualised standard meal

Humalog®

Group Type ACTIVE_COMPARATOR

Humalog®

Intervention Type DRUG

Injection immediately before the start of the individualised standard meal

Interventions

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BioChaperone insulin lispro

Injection immediately before the start of the individualised standard meal

Intervention Type DRUG

Humalog®

Injection immediately before the start of the individualised standard meal

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Adocia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grit Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Profil GmbH

Locations

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Profil Mainz GmbH & Co.KG

Mainz, , Germany

Site Status

Profil GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BC3-CT014

Identifier Type: -

Identifier Source: org_study_id