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A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by Adocia
Sponsor:
Information provided by (Responsible Party):
Adocia
ClinicalTrials.gov Identifier:
NCT02915250
First received: September 21, 2016
Last updated: September 23, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: BioChaperone® Combo
Drug: Humalog® Mix25
Drug: Humalog®
Drug: Lantus®
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Adocia:

Primary Outcome Measures:
  • Delta AUC BG 0-2h (area under the blood glucose concentration-time curve) [ Time Frame: From 0 to 2 hours ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Partial delta AUCs BG and total AUCs BG [ Time Frame: From 0 to 6 hours ] [ Designated as safety issue: No ]
    Partial incremental AUCs BG and total AUCs BG in the 0-6 time range

  • Mean and mean change from baseline of blood glucose at different time points [ Time Frame: From 0 to 6 hours ] [ Designated as safety issue: No ]
  • Delta BGmax and delta BGmin [ Time Frame: From 0 to 6 hours ] [ Designated as safety issue: No ]
    Maximum and minimum blood glucose excursions after a standardised meal

  • BGmax and BGmin [ Time Frame: From 0 to 6 hours ] [ Designated as safety issue: No ]
    Maximum and minimum blood glucose concentrations after a standardised meal

  • AUC Insulin [ Time Frame: From 0 to 24 hours ] [ Designated as safety issue: No ]
    Partial areas under the insulins plasma concentration time curve

  • Cmax Insulin [ Time Frame: From 0 to 6 hours ] [ Designated as safety issue: No ]
    Maximum observed plasma insulins concentration

  • tmax Insulin [ Time Frame: From 0 to 6 hours ] [ Designated as safety issue: No ]
    Time to maximum observed plasma insulins concentration

  • Adverse Events [ Time Frame: Up to 12 weeks (maximum duration of subject's participation) ] [ Designated as safety issue: Yes ]
  • Local tolerability [ Time Frame: Up to 12 weeks (maximum duration of subject's participation) ] [ Designated as safety issue: Yes ]
  • Hypoglycaemic events [ Time Frame: Up to 12 weeks (maximum duration of subject's participation) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: October 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BioChaperone® Combo
Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy
Drug: BioChaperone® Combo
Injection of BioChaperone® Combo
Drug: Placebo
Injection of 0.9% NaCl
Active Comparator: Humalog® Mix25
Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy
Drug: Humalog® Mix25
Injection of Humalog® Mix25
Drug: Placebo
Injection of 0.9% NaCl
Active Comparator: Humalog® and Lantus®
Individualised simultaneous subcutaneous injections
Drug: Humalog®
Injection of Humalog®
Drug: Lantus®
Injection of Lantus®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject aged 18-70 years (both inclusive)
  • Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
  • HbA1c level between 7.5% and 9.5% (both inclusive)
  • Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
  • Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Known or suspected allergy to the IMPs or related products
  • Previous participation in this trial. Participation is defined as randomised.
  • Receipt of any medicinal product in clinical development within 60 days prior to this trial.
  • Clinically significant abnormal haematology, biochemistry, urinalysis or coagulation screening tests, as judged by the Investigator considering the underlying disease
  • Supine blood pressure at screening outside the range of 90-160 mmHg for systolic or 50-95 mmHg for diastolic and/or resting supine heart rate outside the range 50-90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives.
  • Current treatment with premixed or intermediate insulin products, or with long acting insulins other than insulin glargine U-100. The use of short or rapid acting prandial insulin products will be allowed provided their use has been stable for ≥ 3 months prior to screening.
  • Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin alone or metformin in combination with a DPP-4 inhibitor within 4 weeks prior to screening
  • Women of child bearing potential not willing to use contraceptive methods.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02915250

Contacts
Contact: Polya Roydeva +49.6131.2162.636 regulatory@profil.com

Locations
Germany
Profil Mainz GmbH & Co.KG Not yet recruiting
Mainz, Germany, 55116
Contact: Polya Roydeva    +49.6131.2162.636    regulatory@profil.com   
Profil GmbH Not yet recruiting
Neuss, Germany, 41460
Contact: Polya Roydeva    +49.6131.2162.636    regulatory@profil.com   
Sponsors and Collaborators
Adocia
Investigators
Principal Investigator: Leona Plum-Mörschel, MD Profil Mainz GmbH & Co KG
  More Information

Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02915250     History of Changes
Other Study ID Numbers: BC3-CT022 
Study First Received: September 21, 2016
Last Updated: September 23, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Insulin, Isophane
Biphasic Insulins
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016