Back to resultsA Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart 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
NovoRapid®
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Signed and dated informed consent obtained before any trial-related activities.
- Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
- Treated with insulin ≥ 12 months.
- Using a multiple dosing insulin therapy (MDI) with basal and bolus insulin.
- HbA1c ≤ 9.0%.
- Fasting negative C-peptide (≤ 0.30 nmol/L).
- Total daily prandial dose: ≤ 40U in the Part A and ≥ 40 U in the Part B
Exclusion Criteria:
- Known or suspected hypersensitivity to products used in the clinical trial
- Type 2 diabetes mellitus
- Previous participation in this trial. Participation is defined as randomized.
- Receipt of any medicinal product in clinical development within 3 months before randomization in this trial.
- 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.
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
- 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 Type
Experimental
Active Comparator
Arm Label
Co-formulation of insulin analog and pramlintide (ADO09)
NovoRapid®
Arm Description
Subcutaneous injection of ADO09 formulation
Subcutaneous injection of insulin aspart
Outcomes
Primary Outcome Measures
ΔAUCPG(0-4h)
Incremental area under the plasma glucose concentration-time curve from 0-4 hours after start of breakfast, assessed by Super GL at day 24.
Secondary Outcome Measures
Pharmacokinetics of pramlintide
Area under the pramlintide concentration-time curve
Pharmacokinetics of insulins
Area under the insulins concentration-time curve
Plasma glucose control as measured by CGM
Time and percentage of time in Range (TiR) [70-180] mg/dL
Safety and tolerability (Adverse Events recording)
Number of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03981627
Brief Title
A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
Official Title
A Randomized, Single-centre, Double-blind, 2-period Cross-over Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
June 27, 2020 (Actual)
Study Completion Date
June 27, 2020 (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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in subjects with type 1 diabetes mellitus using a Multiple Daily Injection (MDI) regimen.
Detailed Description
After a screening visit, eligible subjects will enter a run-in period. Subjects will receive a Continuous Glucose Monitoring (CGM) system for glucose monitoring and control at the beginning of the run-in and for the whole duration of the study. Each eligible subject will then be randomly allocated to a sequence of the 2 treatments, i.e. multiple daily injections of ADO09 and insulin aspart during 2 dosing periods. At Day 1 a mixed meal test (MMT) will be conducted at breakfast and subjects will remain at the clinical site until day 3. At Day 3 subjects will leave the clinical site and continue the treatment with IMP for the next 3 weeks. On Day 23 subjects will come back for a MMT on Day 24.
This study is constituted of 2 parts. In the first part (Part A), only subjects with daily prandial insulin dose ≤ 40 U/day will be enrolled.
Following the completion of the part A, an extension part (Part B) will be conducted to particularly assess the safety and tolerability of higher daily doses of ADO09 in patients with insulin requirements ≥ 40 U/day.
The clinical conduct and procedures will not change for the Extension Part of the study.
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, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (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
Arm Title
NovoRapid®
Arm Type
Active Comparator
Arm Description
Subcutaneous injection of insulin aspart
Intervention Type
Drug
Intervention Name(s)
ADO09 formulation
Intervention Description
Subcutaneous injection of ADO09 formulation
Intervention Type
Drug
Intervention Name(s)
NovoRapid®
Intervention Description
Subcutaneous injection of insulin aspart
Primary Outcome Measure Information:
Title
ΔAUCPG(0-4h)
Description
Incremental area under the plasma glucose concentration-time curve from 0-4 hours after start of breakfast, assessed by Super GL at day 24.
Time Frame
From 0 to 4 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetics of pramlintide
Description
Area under the pramlintide concentration-time curve
Time Frame
From 0 to 4 hours
Title
Pharmacokinetics of insulins
Description
Area under the insulins concentration-time curve
Time Frame
From 0 to 4 hours
Title
Plasma glucose control as measured by CGM
Description
Time and percentage of time in Range (TiR) [70-180] mg/dL
Time Frame
Over 24 hours
Title
Safety and tolerability (Adverse Events recording)
Description
Number of Adverse Events
Time Frame
Up to 24 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent obtained before any trial-related activities.
Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
Treated with insulin ≥ 12 months.
Using a multiple dosing insulin therapy (MDI) with basal and bolus insulin.
HbA1c ≤ 9.0%.
Fasting negative C-peptide (≤ 0.30 nmol/L).
Total daily prandial dose: ≤ 40U in the Part A and ≥ 40 U in the Part B
Exclusion Criteria:
Known or suspected hypersensitivity to products used in the clinical trial
Type 2 diabetes mellitus
Previous participation in this trial. Participation is defined as randomized.
Receipt of any medicinal product in clinical development within 3 months before randomization in this trial.
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.
Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
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 Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
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