Phase 1
Completed N=44
Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01798264 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Number of Subjects With Study Drug-Related Adverse Events — 9; 11; 9; 11 participants
Summary
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Study Drug-Related Adverse Events |
9; 11; 9; 11 | — |
| SECONDARY To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus |
-0.5; -0.6; -0.5; -0.7 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline |
-5.6; -31.2; -42.0; -28.8 | — |
| SECONDARY Change in Weight From Baseline to 4 Weeks |
-0.3; -0.3; -1.1; -3.1 | — |
Eligibility Criteria
Inclusion Criteria
- type 2 diabetes >6 months
- stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%
Exclusion Criteria
- prior treatment with exenatide
- history of pancreatitis
- history of medullary thyroid cancer or multiple endocrine neoplasia 2
Data sourced from ClinicalTrials.gov (NCT01798264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.