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

• Sponsor: Adocia (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02514850
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Biochaperone Combo; Drug: Humalog Mix25; Drug: Humalog; Drug: Lantus; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biochaperone Combo single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: Biochaperone Combo; Injection of BioChaperone Combo; Drug: Placebo; Injection of saline 0.9% solution
Active Comparator: Humalog Mix25 single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: Humalog Mix25; Injection of Humalog Mix25; Drug: Placebo; Injection of saline 0.9% solution
Active Comparator: Humalog and Lantus simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus	Drug: Humalog; Injection of Humalog; Drug: Lantus; Injection of Lantus

Outcome Measures

Primary Outcome Measures

1. Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg) [from 12h to 30 hours]

   Area under the glucose infusion rate curve from 12 hours to 30 hours

Secondary Outcome Measures

1. AUCGIR 0-last (mg/kg) [Up to 30 hours]

   Area under the glucose infusion rate curve from 0 hours until the end of clamp

2. GIRmax (mg/kg/min) [Up to 30 hours]

   Maximum glucose infusion rate

3. tGIRmax [Up to 30 hours]

   Time to maximum glucose infusion rate

4. AUCLis 0-30h [Up to 30 hours]

   Area under the insulin lispro plasma concentration time curve

5. AUCGla 0-30h [Up to 30 hours]

   Area under the insulin glargine plasma concentration time curve

6. tmax Gla [Up to 30 hours]

   Time to maximum insulin glargine plasma concentration

7. tmax Lis [Up to 30 hours]

   Time to maximum insulin lispro plasma concentration

8. Adverse events [Up to 9 weeks]

   Number of adverse events

9. Hypoglycaemic episodes [Up to 9 weeks]

   Number of Hypoglycaemic episodes

10. Local tolerability [Up to 9 weeks]

    Number and intensity of injection site reactions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profil Institut für Stoffwechselforschung GmbH	Neuss		Germany	41460

Sponsors and Collaborators

• Adocia

Investigators

• Principal Investigator: Ulrike Hövelmann, MD, Profil Institut Für Stoffwechselfforschung GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adocia
• ClinicalTrials.gov Identifier: NCT02514850
• Other Study ID Numbers: BC3-CT018
• First Posted: Aug 4, 2015
• Last Update Posted: Dec 2, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Lispro

Study Results

No Results Posted as of Dec 2, 2015