A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus

• ClinicalTrials.gov Identifier: NCT03512236
• Recruitment Status: Completed
• First Posted: April 30, 2018
• Last Update Posted: February 21, 2019
• Sponsor: Adocia
• Information provided by (Responsible Party): Adocia

Study Description

Brief Summary:

This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes Mellitus	Drug: BC Pram Ins; Drug: Symlin® and Humulin®; Drug: Humalog®; Drug: Placebo	Phase 1

Detailed Description:

This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.

Each subject will be randomly allocated to a sequence of three treatments:(i) simultaneous administrations of BioChaperone® pramlintide human insulin (BC Pram Ins) and placebo, (ii) simultaneous injections of pramlintide (Symlin®) and human insulin (Humulin®) and (iii) simultaneous injections of insulin lispro (Humalog®) and placebo.

Subjects will come in a fasted state to the clinical trial centre in the morning, meal test procedures will be performed and subjects will stay at the clinical trial centre until the post-dose follow-up period has been terminated.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
• Actual Study Start Date: April 25, 2018
• Actual Primary Completion Date: February 14, 2019
• Actual Study Completion Date: February 14, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: BC Pram Ins; Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: BC Pram Ins; Injection of BC Pram Ins; Drug: Placebo; Injection of 0.9% NaCl
Active Comparator: Symlin® and Humulin®; Simultaneous subcutaneous injections avec pramlintide and human insulin	Drug: Symlin® and Humulin®; Injection of pramlintide and human insulin
Active Comparator: Humalog®; Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: Humalog®; Injection of lispro; Drug: Placebo; Injection of 0.9% NaCl

Outcome Measures

Primary Outcome Measures :

1. CmaxPram [ Time Frame: From 0 to 8 hours ]
   Maximum pramlintide concentration
2. AUCPram_0-8h [ Time Frame: From 0 to 8 hours ]
   Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration

Secondary Outcome Measures :

1. Pharmacokinetics of pramlintide [ Time Frame: From 0 to 8 hours ]
   Area Under the pramlintide concentration-time Curve
2. Pharmacokinetics of insulins [ Time Frame: From 0 to 8 hours ]
   Area Under the insulin concentration-time Curve
3. Glucose pharmacodynamics [ Time Frame: From 0 to 8 hours ]
   Area Under the blood glucose concentration-time Curve
4. Safety and tolerability (Adverse Events recording) [ Time Frame: From 0 to 8 hours ]
   Number of adverse events

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Male or female subjects aged 18-64 years (both inclusive)
• Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months
• Treated with multiple daily insulin injections ≥ 12 months
• Treated with an evening dose of once-daily insulin glargine U100 at screening
• Fasting C-peptide ≤ 0.30 nmol/L

Exclusion Criteria:

• Known or suspected hypersensitivity to IMPs, paracetamol (acetaminophen) or related products
• Type 2 diabetes mellitus
• Clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the Investigator considering the underlying disease
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator
• Known slowing of gastric emptying, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption
• Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening

Contacts and Locations

Locations

Germany

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Sponsors and Collaborators

Adocia

Investigators

• Principal Investigator: Grit Andersen, MD; Profil Institut für Stoffwechselforschung GmbH

More Information

• Responsible Party: Adocia
• ClinicalTrials.gov Identifier: NCT03512236 History of Changes
• Other Study ID Numbers: CT031-ADO09
• First Posted: April 30, 2018
• Last Update Posted: February 21, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Insulin, Globin Zinc; Insulin Lispro; Pramlintide; Islet Amyloid Polypeptide; Hypoglycemic Agents; Physiological Effects of Drugs; Appetite Depressants; Anti-Obesity Agents; Amylin Receptor Agonists; Molecular Mechanisms of Pharmacological Action