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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

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Effects of Exenatide and Insulin Glargine in Subjects with Type 2 Diabetes

subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets

subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets

Research Site

A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects with Type 2 Diabetes Treated with Metformin who have not Achieved Target HbA1c

Exenatide Arm 5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.

Age Continuous

Gender, Male/Female

Body Mass Index (BMI)

Study Specific Characteristic

Body weight

Glycosylated hemoglobin (HbA1c)

Duration of diabetes

Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]).

Beta-cell function after 52 weeks of therapy

Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]).

Beta-cell function 4 weeks after cessation of therapy

52 weeks

56 weeks

Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]).  C-peptide is measured as a surrogate marker of insulin secretion.  First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.

Evaluable population.  Last observation carried forward.

Change in first phase C-peptide release

Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]).  C-peptide is measured as a surrogate marker of insulin secretion.  Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.

Change in second phase C-peptide release

Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).

Intent to treat population.  Last observation carried forward.

Change in glycosylated hemoglobin (HbA1c)

Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).

Change in fasting plasma glucose

Pre-breakfast measurement (week 0)

Pre-breakfast measurement (week 52)

2-hour post-breakfast measurement (week 0)

2-hour post-breakfast measurement (week 52)

Pre-lunch measurement (week 0)

Pre-lunch measurement (week 52)

2-hour post-lunch measurement (week 0)

2-hour post-lunch measurement (week 52)

Pre-dinner measurement (week 0)

Pre-dinner measurement (week 52)

2-hour post-dinner measurement (week 0)

2-hour post-dinner measurement (week 52)

Bedtime measurement (week 0)

Bedtime measurement (week 52)

SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).

Seven point self monitored blood glucose (SMBG) measurements

Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).

Change in body weight

baseline (week -2)

week 52

week 56

M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period).  Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56.  Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.

Arms	Assigned Interventions
Experimental: Exenatide Arm Exenatide and Metformin	Drug: exenatide subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets Other Name: Byetta Drug: Metformin Patients usual dosage
Active Comparator: Insulin Glargine Arm Insulin Glargine and Metformin	Drug: Insulin glargine subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets Other Name: Lantus Drug: Metformin Patients usual dosage

Effects of Exenatide and Insulin Glargine in Subjects 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

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator