A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

NCT03916640 | Completed Phase 1

• 1 other identifier: CT034-ADO09
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• CmaxPram

  Maximum pramlintide concentration

  From 0 to 8 hours

• AUCPram 0-8h

  Area under the pramlintide concentration-time curve from 0-8 hours after IMP administration

  From 0 to 8 hours

• CmaxIns

  Maximum insulin analog concentration

  From 0 to 8 hours

• AUCIns 0-8h

  Area under the insulin analog concentration-time curve from 0-8 hours after IMP administration

  From 0 to 8 hours

Secondary Outcomes (4)

• Pharmacokinetics of pramlintide

  From 0 to 8 hours

• Pharmacokinetics of insulins

  From 0 to 8 hours

• Glucose pharmacodynamics

  From 0 to 8 hours

• Safety and tolerability (Adverse Events recording)

  From 0 to 8 hours

Study Arms (3)

Co-formulation of insulin analog and pramlintide (ADO09)

EXPERIMENTAL

Subcutaneous injection of ADO09 formulation + injection of placebo (0.9% NaCl) to ensure double dummy.

Drug: ADO09 formulation; Drug: Placebo

Humulin® + Symlin®

ACTIVE COMPARATOR

Simultaneous, separate subcutaneous injections of human insulin and pramlintide.

Drug: Symlin®; Drug: Humulin®

Humalog®

ACTIVE COMPARATOR

Subcutaneous injection of insulin lispro + injection of placebo (0.9% NaCl) to ensure double dummy.

Drug: Placebo; Drug: Humalog®

Interventions

ADO09 formulation DRUG

Subcutaneous injection of ADO09 formulation

Co-formulation of insulin analog and pramlintide (ADO09)

Placebo DRUG

Subcutaneous injection of 0.9% NaCl

Co-formulation of insulin analog and pramlintide (ADO09); Humalog®

Symlin® DRUG

Subcutaneous injection of pramlintide

Humulin® + Symlin®

Humulin® DRUG

Subcutaneous injection of human insulin

Humulin® + Symlin®

Humalog® DRUG

Subcutaneous injection of insulin lispro

Humalog®

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 Diabetes Mellitus (as diagnosed clinically) ≥ 12 months
• Treated with multiple daily injection ≥ 12 months
• Treated with insulin glargine U100 or U300 or insulin detemir at screening
• Fasting C-peptide ≤ 0.30 nmol/L
• BMI: 18.5-28.0 kg/m² (both inclusive)

You may not qualify if:

• Known or suspected hypersensitivity to IMPs, paracetamol or related products
• Type 2 Diabetes Mellitus
• Clinically significant abnormal haematology, biochemistry or urinalysis screening test, 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

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

pramlintide; Insulin, Regular, Human; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Grit Andersen, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: January 4, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

DE (1)