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

• Sponsor: Adocia (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03916640
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 13

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Drug: ADO09 formulation; Drug: Placebo; Drug: Symlin®; Drug: Humulin®; Drug: Humalog®	Phase 1

Detailed Description

In this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ADO09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. To keep the blinding in this trial, a placebo injection will be given in addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. During each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. IMP administration will be done subcutaneously immediately prior to test meal intake.

Study Design

• Study Type: Interventional
• 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 a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus
• Actual Study Start Date: Jan 4, 2019
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Co-formulation of insulin analog and pramlintide (ADO09) Subcutaneous injection of ADO09 formulation + injection of placebo (0.9% NaCl) to ensure double dummy.	Drug: ADO09 formulation; Subcutaneous injection of ADO09 formulation; Drug: Placebo; Subcutaneous injection of 0.9% NaCl
Active Comparator: Humulin® + Symlin® Simultaneous, separate subcutaneous injections of human insulin and pramlintide.	Drug: Symlin®; Subcutaneous injection of pramlintide; Drug: Humulin®; Subcutaneous injection of human insulin
Active Comparator: Humalog® Subcutaneous injection of insulin lispro + injection of placebo (0.9% NaCl) to ensure double dummy.	Drug: Placebo; Subcutaneous injection of 0.9% NaCl; Drug: Humalog®; Subcutaneous injection of insulin lispro

Outcome Measures

Primary Outcome Measures

1. CmaxPram [From 0 to 8 hours]

   Maximum pramlintide concentration

2. AUCPram 0-8h [From 0 to 8 hours]

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

3. CmaxIns [From 0 to 8 hours]

   Maximum insulin analog concentration

4. AUCIns 0-8h [From 0 to 8 hours]

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

Secondary Outcome Measures

1. Pharmacokinetics of pramlintide [From 0 to 8 hours]

   Area under the pramlintide concentration-time curve

2. Pharmacokinetics of insulins [From 0 to 8 hours]

   Area under the insulins concentration-time curve

3. Glucose pharmacodynamics [From 0 to 8 hours]

   Area under the blood glucose concentration-time curve

4. Safety and tolerability (Adverse Events recording) [From 0 to 8 hours]

   Number of Adverse Events

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

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: Grit Andersen, MD, Profil Institut für Stoffwechselforschung GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adocia
• ClinicalTrials.gov Identifier: NCT03916640
• Other Study ID Numbers: CT034-ADO09
• First Posted: Apr 16, 2019
• Last Update Posted: Apr 16, 2019
• Last Verified: Apr 1, 2019

• 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; Insulin Lispro

Study Results

No Results Posted as of Apr 16, 2019