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Completed

NCT Number: NCT05373212

A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes

This is a randomised, double-blind, four-period crossover euglycaemic clamp trial in subjects with type 2 diabetes.

Each subject will be randomly allocated to one of four treatment sequences. Each sequence will comprise 3 different single doses of BC Combo THDB0207 (Low dose, Medium dose, and High dose) and one single dose of Humalog® Mix25.

Subjects will come to the clinical trial centre in a fasted state in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

About this study

Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device. Prior to dose administration plasma glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose or insulin. IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall.

Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30 hours.

The pharmacodynamic assessment will be based on the time course of glucose infusion rate (GIR) and plasma glucose.

Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin-glargine-M1 and insulin-glargine-M2, and of insulin lispro. Pharmacokinetic assessments will be based on total insulin concentration (insulin glargine + insulin glargine-M1 + insulin glargine-M2 + insulin lispro), on insulin glargine concentration (insulin glargine + insulin glargine-M1 + insulin glargine-M2), or on insulin lispro concentration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
  • HbA1c ≤9.0%
  • Total insulin dose of < 1.2 U/kg/day
  • Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
  • Treated with a stable insulin regimen for ≥ 3 months prior to screening

Exclusion criteria

  • Known or suspected hypersensitivity to the IMPs or any of the excipients or to any component of the IMP formulation
  • Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial
  • Clinically significant abnormal screening laboratory tests, as judged by the Investigator considering the underlying disease
  • Clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data
  • Systolic blood pressure < 90 mmHg or >160 mmHg and/or diastolic blood pressure < 50 mmHg or > 95 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
  • Heart rate at rest outside the range of 50-90 beats per minute
  • Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin within 4 weeks prior to screening
  • Women of childbearing potential who are not using a highly effective contraceptive method

Treatment and study plan

Euglycemic clamp with BC Combo THDB0207

Drug

Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure.

Euglycemic clamp with Humalog® Mix25

Drug

Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure.

Primary outcomes

  1. AUCTOTAL0-last

    Time frame: From t=0 to t=30 hours after IMP administration

    Area under the total insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ

  2. CmaxTOTAL

    Time frame: From t=0 to t=30 hours after IMP administration

    Maximum total insulin concentration

Secondary outcomes

  1. AUCGIR 0-last

    Time frame: From t=0 to t=30 hours after IMP administration

    Area under the glucose infusion rate curve from 0 hours until the end of clamp

  2. GIRmax

    Time frame: From t=0 to t=30 hours after IMP administration

    Maximum glucose infusion rate

  3. tGIRmax

    Time frame: From t=0 to t=30 hours after IMP administration

    Time to maximum glucose infusion rate

  4. Tonset of action

    Time frame: From t=0 to t=30 hours after IMP administration

    Time until Plasma Glucose (PG) has decreased by at least 5 mg/dL from the baseline PG value.

  5. AUCGIR 0-6h

    Time frame: From t=0 to t=6 hours

    Area under the glucose infusion rate curve from t=0 hours to t=6 hours

  6. AUCTOTALlast

    Time frame: From t=0 to t=30 hours after IMP administration

    Area under the insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ

  7. AUCTOTAL 0-1h

    Time frame: From t=0 to t=1 hour

    Area under the total insulin concentration-time curve from t=0 to t=1 hour

  8. AUCTOTAL 0-2h

    Time frame: From t=0 to t=2 hours

    Area under the total insulin concentration-time curve from t=0 to t=2 hours

  9. AUCTOTAL 0-6h

    Time frame: From t=0 to t=6 hours

    Area under the total insulin concentration-time curve from t=0 to t=6 hours

  10. AUCTOTAL 2-6h

    Time frame: From t=2 to t=6 hours

    Area under the total insulin concentration-time curve from t=2 to t=6 hours

  11. AUCTOTAL 6-12h

    Time frame: From t=6 to t=12 hours

    Area under the total insulin concentration-time curve from t=6 to t=12 hours

  12. AUCTOTAL 6-24h

    Time frame: From t=6 to t=24 hours

    Area under the total insulin concentration-time curve from t=6 to t=24 hours

  13. AUCTOTAL 12-24h

    Time frame: From t=12 to t=24 hours

    Area under the total insulin concentration-time curve from t=12 to t=24 hours

  14. AUCTOTAL 12-30h

    Time frame: From t=12 to t=30 hours

    Area under the total insulin concentration-time curve from t=12 to t=30 hours

  15. AUCTOTAL 0-30h

    Time frame: From t=0 to t=30 hours

    Area under the total insulin concentration-time curve from t=0 to t=30 hours

  16. CTOTALmax

    Time frame: From t=0 to t=30 hours after IMP administration

    Maximum insulin concentration

  17. tmaxTOTAL

    Time frame: From t=0 to t=30 hours after IMP administration

    Time to maximum total insulin concentration

  18. AUCGLA 0-last

    Time frame: From t=0 to t=30 hours after IMP administration

    Area under the insulin glargine concentration-time curve from t=0 to the last measured insulin concentration above LLOQ

  19. AUCGLA 0-1h

    Time frame: From t=0 to t=1 hour after IMP administration

    Area under the insulin glargine concentration-time curve from t=0 to t=1 hour

  20. AUCGLA 0-2h

    Time frame: From t=0 to t=2 hours after IMP administration

    Area under the insulin glargine concentration-time curve from t=0 to t=2 hours

  21. AUCGLA 0-6h

    Time frame: From t=0 to t=6 hours after IMP administration

    Area under the insulin glargine concentration-time curve from t=0 to t=6 hours

  22. AUCGLA 2-6h

    Time frame: From t=2 to t=6 hours after IMP administration

    Area under the insulin glargine concentration-time curve from t=2 to t=6 hours

  23. AUCGLA 6-12h

    Time frame: From t=6 to t=12 hours after IMP administration

    Area under the insulin glargine concentration-time curve from t=6 to t=12 hours

  24. AUCGLA 12-24h

    Time frame: From t=12 to t=24 hours after IMP administration

    Area under the insulin glargine concentration-time curve from t=12 to t=24 hours

  25. AUCGLA 12-30h

    Time frame: From t=12 to t=30 hours after IMP administration

    Area under the insulin glargine concentration-time curve from t=12 to t=30 hours

  26. AUCGLA 0-30h

    Time frame: From t=0 to t=30 hours after IMP administration

    Area under the insulin glargine concentration-time curve from t=0 to t=30 hours

  27. CmaxGLA

    Time frame: From t=0 to t=30 hours after IMP administration

    Maximum concentration of insulin glargine

  28. tmaxGLA

    Time frame: From t=0 to t=30 hours after IMP administration

    Time to maximum insulin glargine concentration

  29. AUCLIS0-last

    Time frame: From t=0 to t=30 hours after IMP administration

    Area under the insulin lispro concentration-time curve from t=0 to the last measured insulin concentration above LLOQ

  30. AUCLIS 0-1h

    Time frame: From t=0 to t=1 hour after IMP administration

    Area under the insulin lispro concentration-time curve from t=0 to t=1 hour

  31. AUCLIS 0-2h

    Time frame: From t=0 to t=2 hours after IMP administration

    Area under the insulin lispro concentration-time curve from t=0 to t=2 hours

  32. AUCLIS 0-6h

    Time frame: From t=0 to t=6 hours after IMP administration

    Area under the insulin lispro concentration-time curve from t=0 to t=6 hours

  33. AUCLIS 2-6h

    Time frame: From t=2 to t=6 hours after IMP administration

    Area under the insulin lispro concentration-time curve from t=2 to t=6 hours

  34. AUCLIS 6-12h

    Time frame: From t=6 to t=12 hours after IMP administration

    Area under the insulin lispro concentration-time curve from t=6 to t=12 hours

  35. AUCLIS 12-24h

    Time frame: From t=12 to t=24 hours after IMP administration

    Area under the insulin lispro concentration-time curve from t=12 to t=24 hours

  36. AUCLIS 12-30h

    Time frame: From t=12 to t=30 hours after IMP administration

    Area under the insulin lispro concentration-time curve from t=12 to t=30 hours

  37. AUCLIS 0-30h

    Time frame: From t=0 to t=30 hours after IMP administration

    Area under the insulin lispro concentration-time curve from t=0 to t=30 hours

  38. CmaxLIS

    Time frame: From t=0 to t=30 hours after IMP administration

    Maximum concentration of insulin lispro

  39. tmaxLIS

    Time frame: From t=0 to t=30 hours after IMP administration

    Time to maximum insulin lispro concentration

  40. Adverse Events

    Time frame: From the first IMP administration to the follow-up visit (i.e. up to 14 weeks)

    Incidence of Adverse Events

  41. Local tolerability

    Time frame: From the first IMP administration to the follow-up visit (i.e. up to 14 weeks)

    Incidence of Injection Site Reactions

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Collaborators

  • Tonghua Dongbao Pharmaceutical Co.,Ltd

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 13, 2022
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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