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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

Page last updated: August 23, 2015

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