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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

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ClinicalTrials.gov Identifier: NCT02915250
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Adocia

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: BioChaperone® Combo Drug: Humalog® Mix25 Drug: Humalog® Drug: Lantus® Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Actual Study Start Date : October 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. Delta AUC BG 0-2h (area under the blood glucose concentration-time curve) [ Time Frame: From 0 to 2 hours ]
    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 :
  1. Partial delta AUCs BG and total AUCs BG [ Time Frame: From 0 to 6 hours ]
    Partial incremental AUCs BG and total AUCs BG in the 0-6 time range

  2. Mean and mean change from baseline of blood glucose at different time points [ Time Frame: From 0 to 6 hours ]
  3. Delta BGmax and delta BGmin [ Time Frame: From 0 to 6 hours ]
    Maximum and minimum blood glucose excursions after a standardised meal

  4. BGmax and BGmin [ Time Frame: From 0 to 6 hours ]
    Maximum and minimum blood glucose concentrations after a standardised meal

  5. AUC Insulin [ Time Frame: From 0 to 24 hours ]
    Partial areas under the insulins plasma concentration time curve

  6. Cmax Insulin [ Time Frame: From 0 to 6 hours ]
    Maximum observed plasma insulins concentration

  7. tmax Insulin [ Time Frame: From 0 to 6 hours ]
    Time to maximum observed plasma insulins concentration

  8. Adverse Events [ Time Frame: Up to 12 weeks (maximum duration of subject's participation) ]
  9. Local tolerability [ Time Frame: Up to 12 weeks (maximum duration of subject's participation) ]
  10. Hypoglycaemic events [ Time Frame: Up to 12 weeks (maximum duration of subject's participation) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915250


Locations
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Germany
Profil Mainz GmbH & Co.KG
Mainz, Germany, 55116
Profil GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Investigators
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Principal Investigator: Leona Plum-Mörschel, MD Profil Mainz GmbH & Co KG
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02915250    
Other Study ID Numbers: BC3-CT022
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs