Phase 3
Completed N=691
A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
Source: ClinicalTrials.gov NCT00917267 ↗Enrolled (actual)
691
Serious AEs
3.1%
Results posted
Dec 2012
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26. — -1.43; -1.12 percentage of total hemoglobin — p=<.001
Summary
Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26. |
-1.43; -1.12 | <.001 sig |
| SECONDARY Percentage of Patients Achieving HbA1c Targets <=7% at Week 26 |
46.7; 35.7 | 0.003 sig |
| SECONDARY Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26 |
26.0; 15.5 | <.001 sig |
| SECONDARY Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 |
-40.57; -23.90 | <.001 sig |
| SECONDARY Change in Body Weight (BW) From Baseline to Week 26 |
-1.63; -2.45 | <.001 sig |
| SECONDARY Change in Total Cholesterol (TC) From Baseline to Week 26 |
-9.41; -8.10 | 0.609 |
| SECONDARY Change in High-Density Lipoprotein (HDL) From Baseline to Week 26 |
-0.11; -0.48 | 0.476 |
| SECONDARY Ratio of Triglycerides (TG) at Week 26 to Baseline |
0.97; 0.97 | 0.807 |
| SECONDARY Change in Blood Pressure From Baseline to Week 26 |
-5.33; -5.22; -1.47; -2.24 | — |
| SECONDARY Assessment of Event Rate of Treatment-emergent Hypoglycemic Events |
0.00; 0.01; 0.00; 0.00; 0.24; 0.59 | — |
Eligibility Criteria
Inclusion Criteria
- Have been diagnosed with type 2 diabetes.
- Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.
- Have a body mass index (BMI) of >21 kg/m2 and 5% for at least 90 days prior to study start).
- Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.
Exclusion Criteria
- Have any contraindication for the OAD(s) that they use.
- Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.
- Have received chronic >14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.
- Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.
- Have been treated for >2 weeks with any of the following excluded medications within 90 days prior to study start:
- Insulin
- Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)
- Pramlintide acetate
- Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
- Have had prior exposure to exenatide
- Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Are currently enrolled in any other clinical study.
Data sourced from ClinicalTrials.gov (NCT00917267). 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.