Primary outcomeMean· Day 27/28
Change in 24-hour Mean Weighted Glucose
| Group | Value ((mg/dL)) | Spread |
|---|---|---|
| EQW + Met | 185.7 | 41.99 |
| Placebo + Met | 183.8 | 42.59 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataStudy to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
NCTNCT02288273 (opens ClinicalTrials.gov in a new tab)Other idD5551L00006
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 239 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Dec 2014
- Primary completion
- Aug 2015
- Completion
- Aug 2015
- First posted
- 11 Nov 2014 (estimated)
- Last update posted
- 27 Jan 2017 (estimated)
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016
- Ph 4
Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
NCT02288273Dec 2014 to Aug 2015
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- BydureonDrug
- PlaceboDrug
Arms2
Experimental
Bydureon
Once weekly injected exenatide
Placebo comparator
Placebo
Placebo comparator
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in 24-hour Mean Weighted Glucose
Time frame · Day 27/28
Registry description
Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).
Secondary outcomes(5)
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
Time frame · Day 64/65
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Time frame · Day 22/Day70
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Time frame · Day 22 and Day 64
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Time frame · Week 4 and Week 10
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
Time frame · Day 22 and Day 70
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Day 64/65
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
| Group | Value (mg/dL) | Spread |
|---|---|---|
| EQW + Met | 5.2 | 3.46 |
| Placebo + Met | -6.9 | 3.68 |
Secondary outcomeLeast squares mean· Day 22/Day70
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
| Group | Value (mg/dL) | Spread |
|---|---|---|
| EQW + Met | -29.6 | 4.85 |
| Placebo + Met | -1.9 | 4.99 |
Secondary outcomeLeast squares mean· Day 22 and Day 64
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
| Group | Value (mg/dL) | Spread |
|---|---|---|
| EQW + Met | -32.1 | 5.30 |
| Placebo + Met | -2.0 | 5.51 |
Secondary outcomeLeast squares mean· Week 4 and Week 10
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
| Group | Value (mg/dL) | Spread |
|---|---|---|
| EQW + Met | -4.5 | 1.09 |
| Placebo + Met | -1.8 | 1.13 |
Secondary outcomeLeast squares mean· Day 22 and Day 70
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
| Group | Value (% Alc) | Spread |
|---|---|---|
| EQW + Met | -0.30 | 0.045 |
| Placebo + Met | -0.10 | 0.047 |
Secondary outcomeLeast squares mean· Week 4 and Week 10
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
| Group | Value (% times patients had specific CGM/24-hr) | Spread |
|---|---|---|
| EQW + Met | 0.5 | 0.19 |
| Placebo + Met | 0.2 | 0.19 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| EQW + MetBydureon EQW + Metformin 1500-2000 mg | – | 4 / 60 | 35 / 60 |
| Placebo + MetPlacebo + Metformin 1500 + 2000 mg | – | 1 / 56 | 26 / 56 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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