Phase 2 Completed N=155 Randomized Treatment

Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes

Source: ClinicalTrials.gov NCT00943917 ↗

Enrolled (actual)

155

Serious AEs

3.0%

Results posted

May 2012

Primary outcomePrimary: Mean Change in HbA1c (Per Protocol) — -0.96; -1.04; -0.82 percent change

Summary

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in HbA1c (Per Protocol)	-1.00; -1.23; -0.69; -1.37; -1.45; -1.88	—
PRIMARY Mean Change in HbA1c (ITT)	-1.13; -1.25; -0.48; -1.40; -1.16; -1.84	—

Eligibility Criteria

Inclusion Criteria

Males or females age 18-70 years
Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
Fasting plasma glucose < 240 mg/dL at Screening Visit 1
HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

Exclusion Criteria

Prior treatment with exenatide
Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
History of type 1 diabetes and/or history of diabetic ketoacidosis
Body mass index ≥ 40 kg/m2;
History of organ transplantation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00943917). 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.