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Type 1 Diabetes Mellitus (T1DM)Phase 1NCT04141423

Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil

A Phase 1 study testing Tregopil in people with Type 1 Diabetes Mellitus (T1DM), run by Biocon Limited at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Multi-centre, open label, multiple ascending dose trial in patients with type 1 diabetes mellitus Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Type 1 Diabetes Mellitus (T1DM)
What is being tested?
Tregopil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteGermany
Study dates
28 Oct 2019to 23 Apr 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female patient with diabetes mellitus type 1 on insulin therapy for at least 1 year before screening
  • Age between 18 and 64 years, both inclusive.
  • Body Mass Index (BMI) between 18.5 and 29.0 kg/m2, both inclusive.
  • Body weight between 60 kg and 100 kg, both inclusive and a stable weight +/- 5% for at least 3 months prior to screening (evaluated by patient history or medical history documents).
  • Beta-N-1-deoxy fructosyl haemoglobin (HbA1c) between 6.5 to 9%, both inclusive.
  • Total insulin dose of < 1.2 (I)U/kg/day.
Show all 12Show fewer
  • Daily dose of prandial insulin analogues or regular human insulin not exceeding 70% of total daily insulin dose at screening.
  • Fasting C-peptide <= 0.20 nmol/L.
  • Daily dose of prandial insulin analogues or regular human insulin of at least 21 (I)U per day at screening.
  • Stable basal-bolus insulin regimen for at least 3 months prior to screening (stable as per Investigator's discretion).
  • Patients with experience in insulin titration and self-treatment of hypoglycemic events.
  • Considered generally healthy (apart from conditions associated with T1DM) upon completion of medical history and screening safety assessments including safety lab results, as judged by the Investigator.

Who cannot join

  • Use of continuous subcutaneous insulin infusion (CSII) in the last 3 months prior to screening.
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
  • History of autoimmune disorders other than T1DM as judged clinically relevant by the Investigator (obtained by patient history), except a stable thyroid disorder treated with a stable dose of thyroxin.
  • Hospitalization for diabetic ketoacidosis during the previous 6 months.
  • More than one episode of severe hypoglycemia (as per American Diabetes Association classification) with seizure, coma or requiring assistance of another person during the past 6 months.
  • Hypoglycemic unawareness (defined as individuals with a score of 3 or more [reduced awareness and intermediate awareness] as assessed by the Clarke score).
Show all 27Show fewer
  • Presence of clinically significant acute gastrointestinal (GI) symptoms (e.g. nausea, vomiting, heartburn or diarrhea) within 2 weeks prior to dosing, as judged by the investigator.
  • Presence of chronic GI disorders or conditions known to significantly alter the absorption of orally administered drugs or significantly alter upper GI or pancreatic function, as judged by the Investigator.
  • Patient with previous gastrointestinal surgery, except patients that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as wells as colonic- and gastric endoscopy.
  • Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 12 weeks prior to screening visit.
  • The use of any prescribed medication that would interfere with trial endpoints or the safe completion of the trial procedures like e.g. warfarin, indomethacin or systemic non-selective ß-blocker, as judged by the investigator.
  • Any clinically significant abnormality in ECG or safety laboratory tests (liver function, renal function, hematology, urinalysis or any other laboratory result judged as clinically relevant by the investigator) at screening.
  • Clinically significant cardiovascular and/or cerebrovascular disease within 12 months before Screening, as judged by the Investigator.
  • Active proliferative retinopathy as confirmed by ophthalmoscopy / retinal photography examination performed (by a qualified person as per local legislation) within 6 months prior to screening.
  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 60 mL
  • min/1.73m2 as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
  • History of severe form of neuropathy or clinically significant cardiac autonomic neuropathy (CAN).
  • Patients who needed systemic (oral, intravenous, intramuscular) glucocorticoid therapy within 4 weeks prior to the screening visit OR expected of requiring during the study period.
  • Patients who have undergone pancreatectomy or pancreas/islet cell transplant or had any significant pancreatic disease that affects safety of the patient.
  • Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the study.
  • Patients refusing/not capable to consume three major meals per day on routine basis.
  • If female, pregnancy or breast-feeding.
  • Women of childbearing potential who are not using a highly effective contraceptive method.
  • Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until one month after last dosing.
  • Men of childbearing potential not willing to refrain from sperm donation for the duration of the study and for one month following last dose of study drug.
  • Men with pregnant partner not willing to use male contraception (condom) until one month after last dosing, in order to avoid exposure of the embryo/foetus to seminal fluid.
  • Patients unwilling to avoid heavy machinery work, driving within specified post dose interval during the study treatment period

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Mainz GmbH & Co. KG Malakoff-Passage,Rheinstraße 4C D-55116

    Mainz

Other trials in Germany

About this study

Official title: An Open Label, Multiple Ascending Dose Trial in Patients With T1DM to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin Tregopil and to Evaluate the Postprandial Glucose Control With Different Meal Types in Comparison With Insulin Aspart

Multi-centre, open label, multiple ascending dose trial in patients with type 1 diabetes mellitus

Read the detailed description

This is a Phase 1, open-label, multiple dose trial with two parts in patients with type 1 diabetes mellitus (T1DM). Part 1 consists of four cohorts with multiple ascending doses of insulin Tregopil and comprises a sentinel dosing design. Part 2 consists of a randomised, 2-treatment, crossover design with mixed meal tests (MMTs) of different compositions followed by parallel design titrated treatment period. Both parts include dosing during an in-house period and during a subsequent outpatient period.

Being tested
Tregopil
Keywords
Oral Insulin
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TregopilDrug

    Also called IN-105

    Insulin Tregopil is recombinant human insulin modified by a single amphiphilic oligomer covalently linked via an amide bond to lysine at position 29 of the B-chain. This alters the physicochemical characteristics of the molecule, leading to enhanced stability and resistance to intestinal degradation following oral administration.

Study groups in NCT04141423
Study groupRoleWhat they receive
Tregopil 30 mgActive comparatorDose level cohort with a sentinel dosing design
Receives: Drug: Tregopil
Tregopil 45 mgActive comparatorDose level cohort with a sentinel dosing design
Receives: Drug: Tregopil
Tregopil 60 mgActive comparatorDose level cohort with a sentinel dosing design
Receives: Drug: Tregopil
Derived Dose levelActive comparatorDerived Dose level cohort with a sentinel dosing design (60 mg fixed preprandial dose plus an additional 30 mg postprandial rescue dose, if required)
Receives: Drug: Tregopil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)

    Number of patients with Adverse Events (Part I)

    Measured: Between screening (up to Day -21) and End of study ( up to Day 6)

  2. Laboratory safety parameters

    Number of patients with clinically significant changes in Laboratory safety parameters (Part I)

    Measured: Between screening (up to Day -21) and End of study ( up to Day 6)

  3. Physical examination

    Number of patients with clinically significant changes in Physical examination (Part I)

    Measured: Between screening (up to Day -21) and End of study ( up to Day 6)

  4. Vital signs, clinically

    Number of patients with clinically significant changes in Vital signs (Part I)

    Measured: Between screening (up to Day -21) and End of study ( up to Day 6)

  5. Hypoglycaemic events

    Number of patients with Hypoglycaemia events (Part I)

    Measured: Between screening (up to Day -21) and End of study ( up to Day 6)

  6. Hyperglycaemia events

    Number of patients with Hyperglycaemia events (Part I)

    Measured: Between screening (up to Day -21) and End of study ( up to Day 6)

  7. Electrocardiograms

    Number of patients with clinically significant changes in Electrocardiogram (ECG) (Part I)

    Measured: Between screening (up to Day -21) and End of Treatment ( up to Day 6)

  8. Adverse events (AEs)

    Number of patients with Adverse Events (Part II)

    Measured: Day of screening to Day 20 (Diary) and During follow up Via (Telephone)

  9. Hypoglycaemic events

    Number of patients with Hypoglycaemia events (Part II)

    Measured: Day of screening to Day 20 (Diary) and During follow up Via (Telephone)

  10. Hyperglycaemia events

    Number of patients with Hyperglycaemia events (Part II)

    Measured: Day of Run-in to Day 20 (Diary) and During follow up Via (Telephone)

  11. Laboratory safety parameters

    Number of patients with clinically significant changes in Laboratory safety parameters (Part II)

    Measured: Day of screening and Day 20

  12. Physical examination

    Number of patients with clinically significant changes in Physical examination (Part II)

    Measured: Day of screening, Dosing day 1 and Day 20

  13. Vital signs

    Number of patients with clinically significant changes in Vital signs (Part II)

    Measured: Day of screening, Day1-6 and Day 20)

  14. Electrocardiograms

    Number of patients with clinically significant changes in Electrocardiogram (ECG) (Part II)

    Measured: Day of screening and Day 20

  15. Anti-insulin Tregopil antibodies

    Change in antibody levels (Part II)

    Measured: Day -1 and Day 20

Secondary outcomes (60)

  1. Pharmacokinetics (PK) endpoint-Area under the insulin concentration curve(AUCins).

    Area under the insulin concentration curve (Part I)

    Measured: 0 to 1 hour

  2. PK endpoint-Area under the insulin concentration curve(AUCins).

    Area under the insulin concentration curve (Part 1)

    Measured: 0 to 2 hour

  3. PK endpoint-Area under the insulin concentration curve(AUCins).

    Area under the insulin concentration curve (Part I)

    Measured: 0 to 3 hour

  4. PK endpoint-Area under the insulin concentration curve(AUCins).

    Area under the insulin concentration curve (Part I)

    Measured: 0 to 4 hour

  5. PK endpoint-Area under the insulin concentration curve(AUCins).

    Area under from time zero to the last measurable concentration sampling time (Part I)

    Measured: Time zero to the last measurable concentration (6 hours)

  6. PK endpoint-Area under the insulin concentration curve(AUCins).

    AUC from time zero to infinity (Part I)

    Measured: Day 1, Day 2, Day 6

  7. PK endpoint-time to maximum observed insulin concentration (tmax)

    Time to maximum observed insulin concentration (Part I)

    Measured: Day 1, Day 2, Day 6

  8. PK endpoint-terminal elimination half-life calculated

    Terminal elimination half-life calculated as t½=ln2/ λz (Part I)

    Measured: Day 1, Day 2, Day 6

  9. PK endpoint-Area under the insulin concentration curve in the intended dosing interval (AUCins)

    Area under the insulin concentration curve in the intended dosing interval (Part I)

    Measured: Day 1, Day 2, Day 6

  10. PK endpoint-Insulin concentration at the end of treatment (Ctrough)

    Insulin concentration at the end of treatment (Part I)

    Measured: Day 1, Day 2, Day 6

  11. PK endpoint-Insulin concentration in plasma, tlag (lag time)

    Time to first appearance of insulin concentration in plasma after dosing (Part I)

    Measured: Day 1, Day 2, Day 6

  12. pharmacodynamics (PD) Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals on Day 1, 2 and 6 mixed meal tests

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (Part I)

    Measured: 0-1 hour

  13. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (Part I)

    Measured: 0-2 hour

  14. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (Part I)

    Measured: 0-3 hour

  15. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (Part I)

    Measured: -10 min-6 hour

  16. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (Part I)

    Measured: 0-6 hour

  17. PD Endpoints-Area under the plasma glucose concentration curve in the indicated time intervals

    Area under the plasma glucose concentration curve in the indicated time intervals (Part I)

    Measured: 0-1 hour

  18. PD Endpoints-Area under the plasma glucose concentration curve in the indicated time intervals

    Area under the plasma glucose concentration curve in the indicated time intervals (Part I)

    Measured: 0-2 hour

  19. PD Endpoints-Area under the plasma glucose concentration curve in the indicated time intervals

    Area under the plasma glucose concentration curve in the indicated time intervals (Part I)

    Measured: 0-3 hour

  20. PD Endpoints-Area under the plasma glucose concentration curve in the indicated time intervals

    Area under the plasma glucose concentration curve in the indicated time intervals (Part I)

    Measured: 0-4 hour

  21. PD Endpoints-Area under the plasma glucose concentration curve in the indicated time intervals

    Area under the plasma glucose concentration curve in the indicated time intervals (Part I)

    Measured: 0-6 hour

  22. PD Endpoints-minimum plasma glucose concentration in the indicated time intervals

    Minimum plasma glucose concentration in the indicated time intervals (Part I)

    Measured: 0-1 hour

  23. PD Endpoints-minimum plasma glucose concentration in the indicated time intervals

    Minimum plasma glucose concentration in the indicated time intervals (Part I)

    Measured: 0-2 hour

  24. PD Endpoints-minimum plasma glucose concentration in the indicated time intervals

    Minimum plasma glucose concentration in the indicated time intervals (Part I)

    Measured: 0-3 hour

  25. PD Endpoints-minimum plasma glucose concentration in the indicated time intervals

    Minimum plasma glucose concentration in the indicated time intervals (Part I)

    Measured: 0-4 hour

  26. PD Endpoints-minimum plasma glucose concentration in the indicated time intervals

    Minimum plasma glucose concentration in the indicated time intervals (Part I)

    Measured: 0-6 hour

  27. PD Endpoints-maximal plasma glucose concentration in the indicated time intervals

    Maximal plasma glucose concentration in the indicated time intervals (Part I)

    Measured: 0-2 hour

  28. PD Endpoints-maximal plasma glucose concentration in the indicated time intervals

    Maximal plasma glucose concentration in the indicated time intervals (Part I)

    Measured: 0-4 hour

  29. PD Endpoints-maximal plasma glucose concentration in the indicated time intervals

    Maximal plasma glucose concentration in the indicated time intervals (Part I)

    Measured: 0-6 hour

  30. PD Endpoints-maximal plasma glucose observed sampling period

    maximal plasma glucose observed sampling period (Part I)

    Measured: -10 min-6 hour

  31. PD Endpoints- ΔGmin minimum postprandial plasma glucose increment, absolute and percent

    Minimum postprandial plasma glucose increment, absolute and percent (Part I)

    Measured: 0-6 hour

  32. PD Endpoints- time to onset of action; time to decrease in PG of 5 mg/dL from baseline

    Onset of action; time to decrease in PG of 5 mg/dL from baseline (Part I)

    Measured: 0 hour

  33. Duration of action;

    time from onset of action to increase in PG ≥ 180 mg/dL post meal or time to increase to baseline PG if baseline > 180 mg/dL (Part I)

    Measured: 0- 6 hour

  34. Continuous glucose monitoring (CGM) profile

    daily glycaemic control assessed d by mean (SD) glucose levels, percentage of time in normal range [70-180 mg/dL], percentage of time in hyperglycaemia range [>180 mg/dL], percentage of time in hypoglycaemic range (<70 mg/dL), percentage of readings in the range of 70-180 mg/dL (3.9- 10.0 mmol/L) per unit of time (Part I)

    Measured: 6 days

  35. PK Endpoints- Maximum concentration recorded ( Day 1, 2,3,4,5,6,20)

    Maximum concentration recorded (Cmax) (Part II)

    Measured: 0-4 hours

  36. PK Endpoints-Area under the insulin concentration curve ( Day 1, 2,3,4,5,6,20)

    Area under the insulin concentration curve (AUC) (Part II)

    Measured: 0-1 hours

  37. PK Endpoints-Area under the insulin concentration curve ( Day 1, 2,3,4,5,6,20)

    Area under the insulin concentration curve (AUC) (Part II)

    Measured: 0-2 hours

  38. PK Endpoints-Area under the insulin concentration curve ( Day 1, 2,3,4,5,6,20)

    Area under the insulin concentration curve (AUC) (Part II)

    Measured: 0-4 hours

  39. PK Endpoints-Area under the insulin concentration curve ( Day 1, 2,3,4,5,6,20)

    Area under the insulin concentration curve (aspart) (AUC) (Part II)

    Measured: 0-6 hours

  40. PK Endpoints-Area under the insulin concentration curve ( Day 1, 2,3,4,5,6,20)

    Area under the insulin concentration curve (AUC) (Part II)

    Measured: 0-last

  41. PK Endpoints-Area under the insulin concentration curve ( Day 1, 2,3,4,5,6,20)

    Area under the insulin concentration curve (AUC) (Part II)

    Measured: 0-∞

  42. PK Endpoints- terminal elimination half-life calculated ( Day 1, 2,3,4,5,6,20)

    Terminal elimination half-life calculated as t½=ln2/ λz (Part II)

    Measured: Day 1, Day 2,Day 3,Day 4, Day5, Day 6, Day 20

  43. PK endpoint-time to maximum observed insulin concentration (tmax) ( Day 1, 2,3,4,5,6,20)

    Time to maximum observed insulin concentration (Part II)

    Measured: Day 1, Day 2,Day 3,Day 4, Day5, Day 6, Day 20

  44. PK Endpoints-Area under the insulin concentration curve ( Day 1, 2,3,4,5,6, 20)

    Area under the insulin concentration curve (AUC) (Part II)

    Measured: Day 1, Day 2,Day 3,Day 4, Day5, Day 6, Day 20

  45. PK endpoint-Insulin concentration at the end of treatment ( Day 1, 2,3,4,5,6, 20)

    Insulin concentration at the end of treatment (Ctrough) (Part II)

    Measured: Day 1, Day 2,Day 3,Day 4, Day5, Day 6, Day 20

  46. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (GExc) (Part II)

    Measured: 0-1 hours

  47. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (GExc) (Part II)

    Measured: 0-2 hours

  48. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (GExc) (Part II)

    Measured: 0-3 hours

  49. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (GExc) (Part II)

    Measured: 0-4 hours

  50. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals ( Day 1, 2,3,4,5,6,20)

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (GExc) (Part II)

    Measured: 0-6 hours

  51. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (GAUC) (Part II)

    Measured: 0-1 hours

  52. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (GAUC) (Part II)

    Measured: 0-3 hours

  53. PD Endpoints-Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Area under the plasma glucose concentration excursion from baseline (pre-meal) in the indicated time intervals (GAUC) (Part II)

    Measured: 0-4 hours

  54. PD Endpoints-minimum plasma glucose concentration in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Minimum plasma glucose concentration in the indicated time intervals (Gmin) (Part II)

    Measured: 0-1 hours

  55. PD Endpoints-minimum plasma glucose concentration in the indicated time intervals ( Day 1, 2,3,4,5,6,20)

    Minimum plasma glucose concentration in the indicated time intervals (Gmin) (Part II)

    Measured: 0-3 hours

  56. PD Endpoints-minimum plasma glucose concentration in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Minimum plasma glucose concentration in the indicated time intervals (Gmin) (Part II)

    Measured: 0-4 hours

  57. PD Endpoints-maximal plasma glucose concentration in the indicated time intervals ( Day 1, 2,3,4,5,6, 20)

    Maximal plasma glucose concentration in the indicated time intervals (Gmax) (Part II)

    Measured: 0-4 hours

  58. PD Endpoints -minimal PG concentration in observed sampling period ( Day 1, 2,3,4,5,6, 20)

    minimal PG concentration in observed sampling period (Part II)

    Measured: 0 - 6 hours

  59. PD Endpoints - maximal PG concentration in observed sampling period ( Day 1, 2,3,4,5,6, 20)

    maximal PG concentration in observed sampling period (Part II)

    Measured: 0 - 6 hours

  60. PD Endpoints - CGM profile

    CGM profile

    Measured: Day 1 to 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2019
  2. Study start28 Oct 2019
  3. Primary completion23 Apr 2021
  4. Study completion23 Apr 2021

Why it stopped: Part 1 completed. Part 2 not initiated

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04141423
Sponsor's protocol ID
TREGO-DM1-01-G-02
Status last verified
Jun 2022
First submitted
16 Oct 2019
Last updated
27 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Latres E, Plum-Moerschel L, Murugesan SMN, Lou O, Panda J, Marwah A, Samsonraj R, Gopu CL, Loganathan S, Athalye SN. An open-label, multiple ascending dose trial of orally administered insulin Tregopil in patients with type 1 diabetes mellitus to evaluate its pharmacokinetics, pharmacodynamics, safety and tolerability. Diabetes Obes Metab. 2025 Jun;27(6):3154-3164. doi: 10.1111/dom.16327. Epub 2025 Apr 10.

    PubMed 40211481

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tregopil in people with Type 1 Diabetes Mellitus (T1DM), run by Biocon Limited at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Part 1 completed. Part 2 not initiated). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) (time frame: Between screening (up to Day -21) and End of study ( up to Day 6)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04141423, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.

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