A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
Information source: Adocia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Biochaperone Combo (Drug); Humalog Mix25 (Drug); Humalog (Drug); Lantus (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Adocia Official(s) and/or principal investigator(s): Ulrike Hövelmann, MD, Principal Investigator, Affiliation: Profil Institut Für Stoffwechselfforschung GmbH
Overall contact: Ulrike Hövelmann, MD, Phone: +49 2131 4018-0, Email: ulrike.hoevelmann@profil.com
Summary
This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period
cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin
treatment. Each subject will be randomly allocated to a treatment sequence and will be
administered single subcutaneous doses of 0. 8 U/kg Biochaperone® Combo, 0. 8 U/kg Humalog®
Mix25 or simultaneous subcutaneous injections of 0. 2 U/kg Humalog® and 0. 6 U/kg Lantus®
during three separate dosing visits.
Clinical Details
Official title: A Randomised, Single Dose, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)
Secondary outcome: AUCGIR 0-last (mg/kg)GIRmax (mg/kg/min) tGIRmax AUCLis 0-30h AUCGla 0-30h tmax Gla tmax Lis Adverse events Hypoglycaemic episodes Local tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c levels ≤ 9. 0%
- Total insulin dose of < 1. 2 U/kg/day
- Body mass index between 20. 0 and 35. 0 kg/m2 (both inclusive)
- Body weight ≤ 125. 0 kg
- Fasting serum C-peptide ≤ 1 nmol/L
- Treated with a stable insulin regimen for ≥ 3 months prior to screening
Exclusion Criteria:
- Type 1 diabetes mellitus
- Known or suspected allergy to the trial products or related products
- Previous participation in this trial. Participation is defined as randomised
- Participation in any clinical trial within 3 months prior to this trial
- Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis
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
- Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable
intake of metformin within 4 weeks prior to screening
- Women of child bearing potential, not willing to use contraceptive methods
Locations and Contacts
Ulrike Hövelmann, MD, Phone: +49 2131 4018-0, Email: ulrike.hoevelmann@profil.com
Profil Institut für Stoffwechselforschung GmbH, Neuss 41460, Germany; Recruiting Ulrike Hövelmann, MD, Phone: +49 2131 4018-0
Additional Information
Starting date: July 2015
Last updated: July 31, 2015
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