Phase 3
N=505
Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00082407 ↗Enrolled (actual)
505
Serious AEs
—
Results posted
Jul 2013
Primary outcome: Primary: Change in Glcosylated Hemoglobin (HbA1c) — 8.59; 8.65; -0.98; -0.88 percentage — p=0.2534
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- exenatide (Drug); biphasic insulin aspart (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glcosylated Hemoglobin (HbA1c) |
8.59; 8.65; -0.98; -0.88 | 0.2534 |
| SECONDARY Percentage of Patients Achieving HbA1c <=7% |
31.7; 24.1 | 0.0779 |
| SECONDARY Change in Body Weight |
85.51; 83.38; -2.54; 2.92 | 0.0001 sig |
| SECONDARY Change in Fasting Serum Glucose |
11.00; 11.30; -1.75; -1.64 | 0.6456 |
| SECONDARY Change in 7-point Self-monitored Blood Glucose (SMBG) Profile |
9.57; 9.86; -1.15; -1.68; 12.30; 12.71 | — |
| SECONDARY Percentage of Patients With Hypoglycemic Events |
53.0; 51.6 | 0.7888 |
| SECONDARY Change in Rate of Hypoglycemic Events |
0.22; 0.18; 0.19; 0.26 | 0.3722 |
Summary
This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
Eligibility Criteria
Inclusion Criteria
- Patients have been treated with a stable dose of the following for at least 3 months prior to screening: 1. >=1500 mg/day immediate-release metformin or extended-release metformin and at least an optimally effective dose for brand of sulfonylurea, or 2. a fixed-dose sulfonylurea/metformin combination therapy with the same sulfonylurea and metformin requirements as for the individual components
- HbA1c between 7.0% and 11.0%, inclusive.
- Patients have a body mass index >25kg/m2 and =1.5 mg/dL for males and >=1.2 mg/dL for females.
- Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamic pyruvic transaminase greater than three times the upper limit of the reference range.
- Patients have known hemoglobinopathy or chronic anemia.
- Patients have active proliferative retinopathy or macular edema.
- Patients are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility, including but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
- Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
- Patients have used any prescription drug to promote weight loss within 3 months prior to screening.
- Patients have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides.
- Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator.
- Patients fail to satisfy the investigator of suitability to participate for any other reason.
Data sourced from ClinicalTrials.gov (NCT00082407). 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.