A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)

NCT04816890 | Completed Phase 2

• 1 other identifier: CT041-ADO09
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

In this trial, the treatment of subjects with type 1 diabetes with M1 Pram P037 as co-formulation of pramlintide and A21G human insulin analogue product will be compared with a current standard treatment, insulin lispro. During a four months treatment period doses in both treatment arms may be adjusted and optimised under outpatient conditions to allow a meaningful comparison of both treatments with respect to their effects on body weight, achievable glycaemic control, safety and tolerability, treatment satisfaction and well-being.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Body weight change from baseline to week 16 of treatment

  Change in body weight after 16 weeks of treatment

  From week 0 to week 16

Secondary Outcomes (15)

• TIR [70-180] mg/dL.

  From week 0 to week 16

• %TIR [70-180] mg/dL.

  From week 0 to week 16

• TIR [70-140] mg/dL.

  From week 0 to week 16

• %TIR [70-140] mg/dL.

  From week 0 to week 16

• MeanG_24h

  From week 0 to week 16

Study Arms (2)

M1 Pram P037

EXPERIMENTAL

Multi daily administration of M1 Pram P037 by subcutaneous injection

Drug: M1 Pram P037

Insulin lispro

ACTIVE COMPARATOR

Multi daily administration of insulin lispro (Humalog®) by subcutaneous injection

Drug: Insulin lispro

Interventions

M1 Pram P037 DRUG

Subcutaneous administration of M1 Pram P037 in combination with a basal insulin.

M1 Pram P037

Insulin lispro DRUG

Subcutaneous administration of insulin lispro in combination with a basal insulin.

Insulin lispro

Eligibility Criteria

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

You may qualify if:

• Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject.
• Subjects with type 1 diabetes mellitus.
• Body Mass Index (BMI) between 25.0 and 35.0 kg/m\^2, both inclusive.
• HbA1c between 7.0 % and 9.5 %, both inclusive.
• Diabetes duration of at least 12 months.
• Using a multiple dosing insulin therapy (MDI) with a basal insulin and a rapid-acting insulin at at least two meals per day.
• Using any CGM or Flash Glucose Monitoring (FGM) for at least 1 month or willing to use CGM during the trial.

You may not qualify if:

• Known or suspected hypersensitivity to IMPs or any of the excipients or to any component of the IMP formulation.
• Type 2 diabetes mellitus.
• Receipt of any medicinal product in clinical development within 3 months or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator.
• Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
• Systolic blood pressure \< 90 mmHg or \>139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 mmHg. One repeat test (on a different day, if necessary) will be acceptable in case of suspected white-coat hypertension.
• Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
• Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (\<1.5 years) ophthalmologic examination.
• Severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
• More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
• Hypoglycaemic unawareness as judged by the Investigator.
• Hospitalisation for diabetic ketoacidosis during the previous 6 months.
• Presence of clinically significant gastrointestinal symptoms (e.g., nausea, vomiting, heartburn or diarrhea), as judged by the Investigator.
• Confirmed diagnosis of gastroparesis or requiring the use of drugs that alter gastrointestinal motility.

Sponsors & Collaborators

• Adocia: lead

Study Sites (2)

Profil Mainz GmbH & Co

Mainz, 55116, Germany

Location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

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

Study Officials

• Grit Andersen, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

• Eugen Baumgaertner, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: March 23, 2021
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)