Type II Diabetes Mellitus Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomised, Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KBP-089 in Patients With Type II Diabetes
KeyBioscience is developing KBP-089, a dual activator of both the amylin and calcitonin
receptors, for the treatment of type II diabetes mellitus, using a subcutaneous injectable
mode of administration.
This is a double-blind, placebo-controlled, randomised, multiple-ascending dose phase I trial
to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of
KBP-089 in patients with type 2 diabetes, who are on stable therapy with metformin.
Subjects will receive daily subcutaneous injections in the abdomen over a period of 28 days.
The planned maximum doses of KBP-089 to be investigated in the trial are 20 µg in cohort 1,
60 µg in cohort 2, and 150 µg in cohort 3. For cohort 1, the dose is planned to be escalated
every 7 ±1 days, and for cohort 2 and cohort 3, every 3 days. Doses may be modified according
to individual tolerability, but the dose regimen will not exceed 28 days.
The IMP is administered by daily subcutaneous injections taken in the morning before
breakfast.
The trial is performed in Germany and at least 36 patients will be enrolled in the trial. The
trial will be randomised 1:1:1 between maximum doses of KBP-089 of 20 µg, 60 µg, 150 µg and
placebo. Within each of the three cohorts, 12 patients will be randomised 3:1 to KBP-089 and
placebo.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01952535 -
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01196728 -
Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes
|
Phase 1 | |
| Terminated |
NCT00997152 -
Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
|
Phase 2 | |
| Completed |
NCT02592421 -
SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2
|
Phase 3 | |
| Completed |
NCT05544214 -
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01969084 -
The Effect of Linagliptin on Mitochondrial and Endothelial Function
|
Phase 4 | |
| Terminated |
NCT01644201 -
A Study Evaluating the Effects of a High Viscosity Non-starch Polysaccharide (PolyGlycopleX® - PGX®) on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics
|
Phase 3 | |
| Completed |
NCT00995787 -
Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea
|
Phase 1 | |
| Completed |
NCT01020123 -
Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
|
Phase 2 | |
| Completed |
NCT01505426 -
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
|
Phase 3 | |
| Completed |
NCT01262586 -
Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.
|
Phase 3 | |
| Completed |
NCT00561171 -
Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
|
Phase 2 | |
| Active, not recruiting |
NCT03912363 -
Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids
|
N/A | |
| Completed |
NCT01868646 -
Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus
|
Phase 4 | |
| Active, not recruiting |
NCT06386328 -
A Clinical Trial to Evaluate the Food Effect of CKD-378
|
Phase 1 | |
| Terminated |
NCT02749435 -
A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus
|
N/A | |
| Completed |
NCT00894868 -
Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
|
Phase 4 | |
| Recruiting |
NCT01165190 -
Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans
|
N/A | |
| Completed |
NCT01255085 -
Yellow Pea Protein and Fibre and Short Term Food Intake
|
N/A | |
| Completed |
NCT02156349 -
A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
|
N/A |