| Trial ID: | L2107 |
| Source ID: | NCT02744820
|
| Associated Drug: |
Gmc-252-L-Lysine Salt
|
| Title: |
Multiple Ascending Dose Study of GMC-252-L-Lys Salt in Healthy Subjects and Type 2 Diabetics
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: GMC-252-L-Lysine Salt|OTHER: Placebo
|
| Outcome Measures: |
Primary: Number of Participants with Serious and Non-Serious Adverse Events, Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry), 28 days plus 14 days post last dose | Secondary: Maximal Concentration (Cmax), 28 days plus 14 days post last dose|Area Under the Concentration-Time Curve, 28 days plus 14 days post last dose|Time to reach steady state, 28 days plus 14 days post last dose | Other: Preliminary effect on Fasting blood glucose (Cohort 4 only), 28 days plus 14 days post last dose|Preliminary effect on oral glucose tolerance test (OGTT) (Cohort 4 only), 28 days plus 14 days post last dose|Preliminary effect on Insulin levels (Cohort 4 only), Insulin, 28 days plus 14 days post last dose|Preliminary effect on C-Peptide levels (Cohort 4 only), 28 days plus 14 days post last dose|Preliminary effect on Fructosamine levels (Cohort 4 only), 28 days plus 14 days post last dose|Preliminary effect on %HbA1c (Cohort 4 only), 28 days plus 14 days post last dose
|
| Sponsor/Collaborators: |
Sponsor: Genmedica Therapeutics S.L. | Collaborators: Simbec Research
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
34
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-04
|
| Completion Date: |
2017-09
|
| Results First Posted: |
|
| Last Update Posted: |
2017-10-12
|
| Locations: |
BioKinetic Europe Ltd., Belfast, BT2 7BA, United Kingdom|Simbec Research Ltd, Merthyr Tydfil, CF48 4DR, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02744820
|
