| Trial ID: | L2356 |
| Source ID: | NCT02887625
|
| Associated Drug: |
Pioglitazone Plus Exenatide
|
| Title: |
Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Pioglitazone plus exenatide|DRUG: insulin glargine and insulin aspart
|
| Outcome Measures: |
Primary: HbA1c, difference in HbA1c between the two treatment groups will be compared at 1 and at 3 years to determine efficacy and durability of each treatment, 3 years | Secondary: percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years, 3 years|hypoglycemia rate, will be measured as absolute event rate per patient year of follow up, 3 years|change in the FPG, change in FPG from time zero to 1 year and from baseline to 3 years in each treatment group, 3 years|change in body weight, change in body weight from time zero to 1 year and to 3 years in each treatment group, 3 years
|
| Sponsor/Collaborators: |
Sponsor: Dr. Muhammad Abdulghani
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
410
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-02
|
| Completion Date: |
2017-05
|
| Results First Posted: |
|
| Last Update Posted: |
2016-09-02
|
| Locations: |
Hamad General Hospital, Doha, Qatar
|
| URL: |
https://clinicaltrials.gov/show/NCT02887625
|
