Phase 3
N=235
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00360334 ↗Enrolled (actual)
235
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) — 53.4; 19.8 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- exenatide (Drug); insulin glargine (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) |
53.4; 19.8 | <0.001 sig |
| SECONDARY Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg |
52.5; 16.4 | <0.001 sig |
| SECONDARY Change in Fasting Serum Glucose |
-2.12; -3.61 | <0.001 sig |
| SECONDARY Percent of Patients Achieving HbA1c ≤ 7.4% |
54.2; 61.2 | 0.280 |
| SECONDARY Percent of Patients Achieving HbA1c < 7% |
34.7; 43.1 | 0.191 |
| SECONDARY Percent of Patients Achieving HbA1c < 6.5% |
15.3; 11.2 | 0.363 |
| SECONDARY Change in 7 Point Self Monitored Blood Glucose Profile |
9.98; 9.88; -2.01; -3.99; 13.53; 13.33 | — |
| SECONDARY Change in Body Mass Index (BMI) |
34.49; 33.71; -0.95; 1.01 | <0.001 sig |
| SECONDARY Change in Waist Circumference |
112.07; 110.64; -2.19; 1.97 | <0.001 sig |
| SECONDARY Change in Waist-to-hip Ratio |
0.99; 0.98; -0.02; 0.01 | <0.001 sig |
| SECONDARY Change in Body Weight |
101.19; 97.93; -2.73; 2.98 | <0.001 sig |
| SECONDARY Percent Change in Body Weight |
-2.8; 3.1 | <0.001 sig |
| SECONDARY Percent of Patients Achieving 5% Weight Loss |
19.5; 0.9 | 0.001 sig |
| SECONDARY Percent of Patients Achieving 10% Weight Loss |
4.2; 0.0 | — |
| SECONDARY Change in Systolic Blood Pressure |
134.0; 134.7; -3.6; 0.6 | 0.014 sig |
| SECONDARY Change in Diastolic Blood Pressure |
79.6; 79.7; -0.8; 0.9 | 0.100 |
| SECONDARY Change in Fasting Serum Total Cholesterol (TC) |
-0.36; -0.21 | 0.125 |
| SECONDARY Change in High Density Lipoprotein (HDL) Cholesterol |
0.01; 0.02 | 0.471 |
| SECONDARY Change in TC to HDL Cholesterol Ratio |
-0.40; -0.34 | 0.601 |
| SECONDARY Change in Fasting Serum Triglycerides |
-0.33; -0.38 | 0.650 |
| SECONDARY Change in Low Density Lipoprotein (LDL) Cholesterol |
-0.25; -0.07 | 0.017 sig |
| SECONDARY Change in Apolipoprotein-B |
-0.09; -0.08 | 0.667 |
| SECONDARY Incidence of Hypoglycemic Episodes |
50.0; 59.6 | 0.139 |
| SECONDARY Incidence of Nocturnal Hypoglycemic Episodes |
11.9; 29.8 | 0.001 sig |
| SECONDARY Incidence of Severe Hypoglycemic Episodes |
4.2; 5.3 | 0.716 |
| SECONDARY Hypoglycemic Rate Per 30 Days |
0.069; 0.164 | 0.113 |
| SECONDARY Nocturnal Hypoglycemic Rate Per 30 Days |
0.000; 0.000 | <0.001 sig |
| SECONDARY Severe Hypoglycemic Rate Per 30 Days |
0.000; 0.000 | 0.740 |
Summary
This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes
- Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
- HbA1c between 7.5% and 10.0%.
- BMI >27.
Exclusion Criteria
- Receive 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 study.
- Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
- Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months.
- 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.
Data sourced from ClinicalTrials.gov (NCT00360334). 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.