EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin treated Patients with Type 2 Diabetes.

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

NCT ID

Therapeutic Area

Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.

Research Site

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

Age Continuous

Gender, Male/Female

239 subjects were screened in order to randomize 117 subjects; however, 116 subjects were included in the modified intent to treat population, which consisted of all randomized patients who received at least one dose of randomized study drug.


Baseline (Day -1/1)

Day 27/28

Change from Baseline to Day 27/28

Change from Baseline to Day 69/70

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).

Change in 24-hour mean weighted glucose

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

Baseline to Day 22

Baseline to Day 70

Change from baseline (Day1) to Day 70 and Day 22 in FPG

Baseline to Day 64

Change from baseline (Day -1) to Day 64 and Day 22 in 2- hour mean weighted PPG (after the breakfast meal)

Change in mean weighted glucose baseline to Week 4

Change in mean weighted glucose baseline - Week 10

Change in MAGE (mg/dL) from baseline to Week 4

Change in MAGE (mg/dL) from baseline to Week 10

Average of change in 24-hour mean weighted glucose from baseline to Week 4 and baseline to Week 10

Change from baseline to Day 22

Change from baseline to Day 70

Change in HbA1c from baseline to Day 22 and baseline to Day 70

Change in times(%): PG<70 baseline to Week 4

Change in times (%):  PG <70 baseline to Week 10

Change in %: 70 </= PG </=180 baseline to week 4

Change in %: 70 </= PG </=180 baseline to week 10

Change in times (%): PG >180 baseline to Week 4

Change in times (%): PG >180 baseline to Week 10

Overall Study

239 subjects were screened in order to randomize 117 subjects; however, 116 subjects were included in the modified intent to treat population, which consisted of all randomized patients who received at least one dose of randomized study drug.

Sergey Zhuplatov MD, PhD

Change in 24-hour mean weighted glucose within each extended-release formulation of exenatide (EQW)-treated patient

Change from baseline in 2-hour mean weighted PPG

Average of change in 24-hour mean weighted glucose from baseline to Days 1 to 6 of Week 10 and Week 4 calculated.

Change from baseline to Day 69 and Day 27 in 2-hour mean weighted PPG

Arms	Assigned Interventions
Experimental: Bydureon Once weekly injected exenatide	Drug: Bydureon Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks. Other Name: exenatide
Placebo Comparator: Placebo Placebo comparator	Drug: Placebo Placebo

Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin treated Patients with Type 2 Diabetes.

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

D5551L00006_Protocol_Redacted

Trial Results Summaries

Contacts

Contact