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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

ADO09 formulation

Placebo

Symlin®

Humulin®

Humalog®

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Profil Institut für Stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Co-formulation of insulin analog and pramlintide (ADO09)

Humulin® + Symlin®

Humalog®

Arm Description

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

Simultaneous, separate subcutaneous injections of human insulin and pramlintide.

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

Outcomes

Primary Outcome Measures

CmaxPram

Maximum pramlintide concentration

AUCPram 0-8h

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

CmaxIns

Maximum insulin analog concentration

AUCIns 0-8h

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

Secondary Outcome Measures

Pharmacokinetics of pramlintide

Area under the pramlintide concentration-time curve

Pharmacokinetics of insulins

Area under the insulins concentration-time curve

Glucose pharmacodynamics

Area under the blood glucose concentration-time curve

Safety and tolerability (Adverse Events recording)

Number of Adverse Events

Full Information

NCT ID

NCT03916640

First Posted

April 12, 2019

Last Updated

April 12, 2019

Sponsor

Adocia

1. Study Identification

Unique Protocol Identification Number

NCT03916640

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

January 4, 2019 (Actual)

Primary Completion Date

March 1, 2019 (Actual)

Study Completion Date

March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Adocia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Co-formulation of insulin analog and pramlintide (ADO09)

Arm Type

Experimental

Arm Description

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

Arm Title

Humulin® + Symlin®

Arm Type

Active Comparator

Arm Description

Simultaneous, separate subcutaneous injections of human insulin and pramlintide.

Arm Title

Humalog®

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ADO09 formulation

Intervention Description

Subcutaneous injection of ADO09 formulation

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous injection of 0.9% NaCl

Intervention Type

Drug

Intervention Name(s)

Symlin®

Intervention Description

Subcutaneous injection of pramlintide

Intervention Type

Drug

Intervention Name(s)

Humulin®

Intervention Description

Subcutaneous injection of human insulin

Intervention Type

Drug

Intervention Name(s)

Humalog®

Intervention Description

Subcutaneous injection of insulin lispro

Primary Outcome Measure Information:

Title

CmaxPram

Description

Maximum pramlintide concentration

Time Frame

From 0 to 8 hours

Title

AUCPram 0-8h

Description

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

Time Frame

From 0 to 8 hours

Title

CmaxIns

Description

Maximum insulin analog concentration

Time Frame

From 0 to 8 hours

Title

AUCIns 0-8h

Description

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

Time Frame

From 0 to 8 hours

Secondary Outcome Measure Information:

Title

Pharmacokinetics of pramlintide

Description

Area under the pramlintide concentration-time curve

Time Frame

From 0 to 8 hours

Title

Pharmacokinetics of insulins

Description

Area under the insulins concentration-time curve

Time Frame

From 0 to 8 hours

Title

Glucose pharmacodynamics

Description

Area under the blood glucose concentration-time curve

Time Frame

From 0 to 8 hours

Title

Safety and tolerability (Adverse Events recording)

Description

Number of Adverse Events

Time Frame

From 0 to 8 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Grit Andersen, MD

Organizational Affiliation

Profil Institut für Stoffwechselforschung GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Profil Institut für Stoffwechselforschung GmbH

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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