| Trial ID: | L4194 |
| Source ID: | NCT00360334
|
| Associated Drug: |
Exenatide
|
| Title: |
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00360334/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: exenatide|DRUG: insulin glargine
|
| Outcome Measures: |
Primary: Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg), Composite endpoint evaluating effect of treatment on glycemic control and weight, 26 weeks | Secondary: Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg, Composite endpoint evaluating effect of treatment on glycemic control and weight, 26 weeks|Change in Fasting Serum Glucose, Change in fasting serum glucose from baseline (week 0) to endpoint (week 26), 26 weeks|Percent of Patients Achieving HbA1c ≤ 7.4%, Percent of patients achieving specified HbA1c target at endpoint, 26 weeks|Percent of Patients Achieving HbA1c < 7%, Percent of patients achieving specified HbA1c target at endpoint, 26 weeks|Percent of Patients Achieving HbA1c < 6.5%, Percent of patients achieving specified HbA1c target at endpoint, 26 weeks|Change in 7 Point Self Monitored Blood Glucose Profile, Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day, 26 weeks|Change in Body Mass Index (BMI), Change in BMI from baseline to endpoint, 26 weeks|Change in Waist Circumference, Change in waist circumference from baseline to endpoint, 26 Weeks|Change in Waist-to-hip Ratio, Change in waist-to-hip ratio from baseline to endpoint, 26 weeks|Change in Body Weight, Change in body weight from baseline to endpoint, 26 weeks|Percent Change in Body Weight, Percent change in baseline body weight at endpoint, 26 Weeks|Percent of Patients Achieving 5% Weight Loss, Percent of patients who lost at least 5% of baseline body weight at endpoint, 26 weeks|Percent of Patients Achieving 10% Weight Loss, Percent of patients who lost at least 10% of baseline body weight at endpoint, 26 weeks|Change in Systolic Blood Pressure, Change in systolic blood pressure from baseline to endpoint, 26 weeks|Change in Diastolic Blood Pressure, Change in diastolic blood pressure from baseline to endpoint, 26 weeks|Change in Fasting Serum Total Cholesterol (TC), Change in TC from baseline to endpoint, 26 weeks|Change in High Density Lipoprotein (HDL) Cholesterol, Change in HDL cholesterol from baseline to endpoint, 26 weeks|Change in TC to HDL Cholesterol Ratio, Change in TC to HDL cholesterol ratio from baseline to endpoint, 26 weeks|Change in Fasting Serum Triglycerides, Change in fasting serum triglycerides from baseline to endpoint, 26 weeks|Change in Low Density Lipoprotein (LDL) Cholesterol, Change in LDL cholesterol from baseline to endpoint, 26 weeks|Change in Apolipoprotein-B, Change in apolipoprotein-B from baseline to endpoint, 26 weeks|Incidence of Hypoglycemic Episodes, Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study, 26 weeks|Incidence of Nocturnal Hypoglycemic Episodes, Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study, 26 weeks|Incidence of Severe Hypoglycemic Episodes, Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study, 26 weeks|Hypoglycemic Rate Per 30 Days, Number of hypoglycemic episodes per patient adjusted per 30 days, 26 weeks|Nocturnal Hypoglycemic Rate Per 30 Days, Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days, 26 weeks|Severe Hypoglycemic Rate Per 30 Days, Number of severe hypoglycemic episodes per patient adjusted per 30 days, 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
235
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-06
|
| Completion Date: |
2008-04
|
| Results First Posted: |
2009-06-05
|
| Last Update Posted: |
2015-04-07
|
| Locations: |
Research Site, Aberdeen, United Kingdom|Research Site, Bath, United Kingdom|Research Site, Blackburn, United Kingdom|Research Site, Bolton, United Kingdom|Research Site, Bournemouth, United Kingdom|Research Site, Bristol, United Kingdom|Research Site, Chippenham, United Kingdom|Research Site, Edinburgh, United Kingdom|Research Site, Glasgow, United Kingdom|Research Site, Haywards Heath, United Kingdom|Research Site, High Wycombe, United Kingdom|Research Site, Hull, United Kingdom|Research Site, Ipswich, United Kingdom|Research Site, Kent, United Kingdom|Research Site, Leicester, United Kingdom|Research Site, Liverpool, United Kingdom|Research Site, Livingstone, United Kingdom|Research Site, London, United Kingdom|Research Site, Manchester, United Kingdom|Research Site, Middlesborough, United Kingdom|Research Site, Norwich, United Kingdom|Research Site, Nottingham, United Kingdom|Research Site, Oldham, United Kingdom|Research Site, Oxford, United Kingdom|Research Site, Plymouth, United Kingdom|Research Site, Rochdale, United Kingdom|Research Site, Salford, United Kingdom|Research Site, Swansea, United Kingdom|Research Site, Torquay, United Kingdom|Research Site, Wakefield, United Kingdom|Research Site, Wirral, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00360334
|
