EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

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.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight,
lipids, safety, and tolerability.

Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

subcutaneous injection, 2.0mg, once a week;

subcutaneous injection, titrated to achieve fasting serum glucose target, once a day

Research Site

Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated with Oral Antidiabetic(s)

Change in HbA1c from baseline to endpoint (Week 26).

Age Categorical

Age Continuous

Gender, Male/Female

Glycosylated hemoglobin (HbA1c)

Study Specific Characteristic

Weight

Background Oral Antidiabetic Agent (OAD)

The expected changes in HbA1c from baseline were considered to be the same between the groups, and the common standard deviation assumed to be 1.2%. Assuming a type I error of 0.025 (one-sided), a power of 0.9 and a noninferiority margin of 0.4%, 191 subjects per group would be necessary to confirm the noninferiority by the two-sample t-test. When the proportion of the subjects missing post-baseline data was assumed to be 10%, the target number of subjects were 420 in total (210 subjects/group).

Statistical analysis of this study was performed for the full analysis set (FAS). FAS consisted of randomized patients who received administration of the study drug at least once and had measurement values after administration. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.

Change in HbA1c from baseline to endpoint (Week 26)

Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)

Percentage of subjects achieving HbA1c<=7% at endpoint were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.

FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.

Percentage of subjects achieving HbA1c<=7%

Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)

Percentage of subjects achieving HbA1c<=6.5% at endpoint were compared between treatments using a CMH test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.

Percentage of subjects achieving HbA1c<=6.5%

Change in FSG (centralized measurement) from baseline to endpoint (Week 26)

Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.

FAS Population. Missing data at endpoint was imputed using LOCF approach.

Change in Fasting serum glucose (FSG) from baseline to endpoint (Week 26)

Change in Body Weight from baseline to endpoint (Week 26)

Change in body weight from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline body weight as a covariate.

Change in Total Cholesterol from baseline to endpoint (Week 26)

Change in total cholesterol from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline total cholesterol as a covariate.

Change in Total cholesterol from baseline to endpoint (Week 26)

Change in HDL-C from baseline to endpoint (Week 26)

Change in HDL-C from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pre-treatment with SU as factors and baseline HDL-C as a covariate.

Change in High-density lipoprotein cholesterol (HDL-C) from baseline to endpoint (Week 26)

Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.

Triglycerides data were logarithm-transformed and the change at endpoint to baseline, expressed as the ratio, was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline triglycerides as a covariate.

Ratio of Fasting triglycerides at endpoint (Week 26) to Baseline

Systolic Blood Pressure

Diastolic Blood Pressure

Change in Blood Pressure from baseline to endpoint (Week 26)

Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.

Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events

Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.

Arms	Assigned Interventions
Experimental: exenatide once weekly	Drug: exenatide once weekly subcutaneous injection, 2.0mg, once a week;
Active Comparator: insulin glargine	Drug: insulin glargine subcutaneous injection, titrated to achieve fasting serum glucose target, once a day Other Name: insulin glargine-Lantus

Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

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

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator