Phase 4
Completed N=117
Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
Source: ClinicalTrials.gov NCT02288273 ↗Enrolled (actual)
117
Serious AEs
4.3%
Results posted
Jan 2017
Primary outcomePrimary: Change in 24-hour Mean Weighted Glucose — 185.7; 183.8; 158.3; 176.9 (mg/dL) — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 24-hour Mean Weighted Glucose |
185.7; 183.8; 158.3; 176.9; -26.0; -5.3 | <0.001 sig |
| SECONDARY Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient |
5.2; -6.9 | — |
| SECONDARY Change From Baseline (Day1) to Day 70 and Day 22 in FPG |
-29.6; -1.9; -41.9; -5.0 | — |
| SECONDARY Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal) |
-32.1; -2.0; -44.4; -6.0 | — |
| SECONDARY Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10 |
0.5; 0.2; 0.5; 0.1; 15.8; 4.1 | — |
| SECONDARY Change in HbA1c From Baseline to Day 22 and Baseline to Day 70 |
-0.30; -0.10; -0.92; -0.20 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin > or = to 1500mg/day as monotherapy for at least 8 weeks
- Hemoglobin A1c (HbA1c) 7% to 10% at screening
- Body mass index (BMI) < or = to 45 kg/m2
Exclusion Criteria
- History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening
- History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening
- History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
- History of prescription or over the counter weight loss medication during 3 months prior to screening
- Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to screening
Data sourced from ClinicalTrials.gov (NCT02288273). 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.