Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180710
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Adocia

Brief Summary:
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: BioChaperone® Combo 75/25 at 0.6 U/kg Drug: BioChaperone® Combo 75/25 at 0.8 U/kg Drug: BioChaperone® Combo 75/25 at 1.0 U/kg Drug: Humalog® Mix25 at 0.8 U/kg Phase 1

Detailed Description:

This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

Each subject will be randomly allocated to a sequence of four treatments, three single doses of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog® Mix25 at 0.8 U/kg on four separate dosing visits.

Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BioChaperone® Combo 75/25 at 0.6 U/kg
Single subcutaneous injection of 0.6 U/kg
Drug: BioChaperone® Combo 75/25 at 0.6 U/kg
Injection of BioChaperone® Combo 75/25 at 0.6 U/kg

Experimental: BioChaperone® Combo 75/25 at 0.8 U/kg
Single subcutaneous dose of 0.8 U/kg
Drug: BioChaperone® Combo 75/25 at 0.8 U/kg
Injection of BioChaperone® Combo 75/25 at 0.8 U/kg

Experimental: BioChaperone® Combo 75/25 at 1.0 U/kg
Single subcutaneous dose of 1.0 U/kg
Drug: BioChaperone® Combo 75/25 at 1.0 U/kg
Injection of BioChaperone® Combo 75/25 at 1.0 U/kg

Active Comparator: Humalog® Mix25 at 0.8 U/kg
Single subcutaneous dose of 0.8 U/kg
Drug: Humalog® Mix25 at 0.8 U/kg
Injection of Humalog® Mix25 at 0.8 U/kg




Primary Outcome Measures :
  1. AUC last_total [ Time Frame: From 0 to 30 hours ]
    Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ. The total insulin concentration is the sum of lispro and basal concentrations.

  2. Cmax_total [ Time Frame: From 0 to 30 hours ]
    Maximum observed plasma insulin total concentration


Secondary Outcome Measures :
  1. AUCGIR 0-last (mg/kg) [ Time Frame: From 0 to 30 hours ]
    Area under the glucose infusion rate curve from 0 hours until the end of clamp

  2. GIRmax (mg/kg/min) [ Time Frame: From 0 to 30 hours ]
    Maximum glucose infusion rate

  3. tGIRmax [ Time Frame: From 0 to 30 hours ]
    Time to maximum glucose infusion rate

  4. Adverse Events [ Time Frame: Up to 102 days (maximum duration of subject's participation) ]
  5. Local tolerability: number of injection site reaction [ Time Frame: Up to 102 days (maximum duration of subject's participation) ]
    Frequency of injection site reaction in each arm.

  6. Number of hypoglycaemic events in each treatment arm [ Time Frame: Up to 102 days (maximum duration of subject's participation) ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 6.5% and 9.0 % (both inclusive)
  • Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
  • Body weight <= 125.0 kg at the screening visit
  • Insulin-treated subjects. Total insulin dose of <= 1.2 (I)U/kg/day

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Known or suspected hypersensitivity to IMP(s) or related products
  • Previous participation in this trial. Participation is defined as randomised.
  • Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial.
  • Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease.
  • Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-160 mmHg systolically or 50-95 mmHg diastolically (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial); symptoms of arterial hypotension and/or a heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
  • 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): NCT03180710


Locations
Layout table for location information
Germany
Profil Mainz GmbH & Co. KG
Mainz, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Sponsors and Collaborators
Adocia
Investigators
Layout table for investigator information
Principal Investigator: Oliver Klein, MD Profil Institut für Stoffwechselforschung GmbH
Layout table for additonal information
Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT03180710    
Other Study ID Numbers: BC3-CT025
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs