28 completed, 1 unknown. 26 Phase 1, 6 Phase 2, 1 Phase 3.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers
Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Humalog® Mix25, Euglycemic clamp with Humalog® and Lantus® - Healthy | Phase 1 | Completed | Adocia | 27 | 2022-05-12 | 2023-10-12 |
A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes
Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Lantus®, Euglycemic clamp with Humalog® - Type 1 Diabetes | Phase 1 | Completed | Adocia | 30 | 2022-05-12 | 2023-09-15 |
A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes
Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Humalog® Mix25 - Type 2 Diabetes | Phase 1 | Completed | Adocia | 40 | 2022-05-12 | 2023-09-15 |
Safety and Efficacy of BC LisPram
50-Hour Intervention - Rapid Insulin lispro, 50-Hour Intervention - BC LisPram - Type1 Diabetes Mellitus | Phase 1 | Unknown | Michael Tsoukas | 16 | 2021-07-28 | 2022-02-16 |
A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)
M1 Pram P037, Insulin lispro - Type 1 Diabetes Mellitus | Phase 2 | Completed | Adocia | 80 | 2021-03-23 | 2022-06-24 |
A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus
Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1), Administration of Ready-to-use BioChaperone insulin lispro (IMP2), Administration of US-approved Humalog® (IMP3) - Type 1 Diabetes | Phase 1 | Completed | Adocia | 32 | 2020-08-03 | 2020-11-30 |
A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
ADO09 formulation, NovoRapid® - Type 1 Diabetes Mellitus | Phase 1 / Phase 2 | Completed | Adocia | 44 | 2019-06-06 | 2020-11-30 |
A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus
ADO09 formulation, Placebo, Symlin® - Type 1 Diabetes Mellitus | Phase 1 | Completed | Adocia | 24 | 2019-01-04 | 2019-04-16 |
A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
BC Pram Ins, Symlin® and Humulin®, Humalog® - Type 1 Diabetes Mellitus | Phase 1 | Completed | Adocia | 24 | 2018-04-25 | 2019-02-21 |
A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump
BioChaperone® insulin lispro, Fiasp®, Novorapid® - Type1 Diabetes Mellitus | Phase 1 | Completed | Adocia | 43 | 2017-06-20 | 2017-12-12 |
A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
BioChaperone® glucagon formulation 1, BioChaperone® glucagon formulation 2, GlucaGen® HypoKit® - Type 1 Diabetes Mellitus | Phase 1 | Completed | Adocia | 27 | 2017-06-06 | 2017-12-12 |
A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
BioChaperone® Combo 75/25 at 0.6 U/kg, BioChaperone® Combo 75/25 at 0.8 U/kg, BioChaperone® Combo 75/25 at 1.0 U/kg - Type 2 Diabetes Mellitus | Phase 1 | Completed | Adocia | 32 | 2017-06-06 | 2018-01-10 |
A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
BioChaperone® Combo, Humalog® Mix25, Humalog® - Type 2 Diabetes Mellitus | Phase 1 | Completed | Adocia | 36 | 2016-10-01 | 2017-06-29 |
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM
BioChaperone Human Insulin (HinsBet®), Insulin Lispro (Humalog®), Regular human insulin (Huminsulin® Normal) - Type 1 Diabetes Mellitus | Phase 1 / Phase 2 | Completed | Adocia | 36 | 2016-04-01 | 2016-08-18 |
An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
Biochaperone insulin lispro 0.1 U/kg, Biochaperone insulin lispro 0.2 U/kg, Biochaperone insulin lispro 0.4 U/kg - Healthy | Phase 1 | Completed | Adocia | 15 | 2016-01-01 | 2016-05-30 |
A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
BioChaperone insulin lispro, Humalog® - Type 2 Diabetes Mellitus | Phase 1 | Completed | Adocia | 51 | 2015-09-01 | 2016-04-29 |
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
BioChaperone insulin lispro, Humalog® - Type 1 Diabetes Mellitus | Phase 1 | Completed | Adocia | 80 | 2015-09-01 | 2016-11-22 |
A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers
BioChaperone Lispro U-100, BioChaperone Lispro U-200 - Healthy | Phase 1 | Completed | Adocia | 26 | 2015-08-01 | 2015-12-18 |
To Investigate the Efficacy and Safety of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus
BioChaperone insulin lispro, Humalog® - Type 1 Diabetes Mellitus | Phase 1 | Completed | Adocia | 36 | 2015-08-01 | 2016-03-16 |
Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
Biochaperone® Combo, Humalog® Mix25 - Type 1 Diabetes Mellitus | Phase 1 | Completed | Adocia | 28 | 2015-07-01 | 2015-11-06 |
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Conditions studied
Diabetes Mellitus, Type 1 (16) · Diabetes Mellitus, Type 2 (5) · Diabetic Foot (2) · Diabetes Mellitus (1)
Interventions
Insulin Lispro (18) · Insulin Glargine (4) · Glucose Clamp Technique (3) · Insulin Aspart (2) · Insulin, Regular, Human (2) · pramlintide (2) · Becaplermin (1) · IGF2BP2 protein, human (1) · Insulin (1) · Standard of Care (1) · insulin lispro, isophane insulin lispro drug combination (25:75) (1) · signal peptide peptidase (1)
Countries
Germany (25) · India (2) · Canada (1) · Singapore (1)
Top investigators
Grit Andersen, MD (11) · Oliver Klein, MD (5) · Eugen Baumgaertner, MD (2) · Arun Bal, MD (1) · Marc Stoffel, MD (1) · Michael Tsoukas, MD (1) · T C Raghuram, MD, Phd (1) · Tim Heise, MD (1)
Results publications
PMID 36633505, PMID 39109464
NIH funding
2014 (1)