- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02887625
Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM
Efficacy and Durability of Glucagon Like Peptide 1 Receptor Agonists (GLP-1 RA)/Thiazolidinedione Versus Basal Bolus Insulin Therapy in Poorly Controlled Type 2 Diabetic Patients (T2DM) Patients on Sulfonylurea Plus Metformin
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
poorly controlled (HbA1c >7.5%) T2DM patients (18-75 years of age) on maximal/near maximal dose of sulfonylurea plus metformin who otherwise are healthy will be randomized to receive:
- exenatide weekly injection (2 mg/week)
- glargine insulin plus insulin aspart which will be titrated to maintain HbA1c <7.0%
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Abdul-Ghani, MD, PhD
- Phone Number: 44391208
- Email: ABDULGHANI@UTHSCSA.EDU
Study Contact Backup
- Name: Amin Jayyousi, MD
- Phone Number: 55530236
- Email: ajayyousi@hamad.qa
Study Locations
-
-
-
Doha, Qatar
- Recruiting
- Hamad General Hospital
-
Contact:
- Osama Mujahed, MD
- Phone Number: 66703172
- Email: pvedromigahid@gmail.com
-
Contact:
- Ayman Mujahed, MD
- Phone Number: 44391208
- Email: ymndodo20@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- T2DM poorly controlled (HbA1c >7.5%) on metformin (>1700 mg/day) plus sulfonylurea
Exclusion Criteria:
- type 1 diabetes (T1DM) patients receiving therapy with pioglitazone, GLP-1 RA and insulin abnormal kidney, liver or heart function patients with malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Combination Therapy
pioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week
|
pioglitazone will be started at 30 mg/day and bydureon at 2 mg/week
Other Names:
|
Active Comparator: Insulin Therapy
insulin glargine (lantus) will be started every morning and the dose will be weekly increase to achieve fasting plasma glucose (FPG) <110 mg/dl. and Aspart insulin will be started before meals and the dose is adjusted to maintain HbA1c <7.0% and postprandial plasma glucose (PPG) <140 mg/dl |
the dose will be escalated to maintain HbA1c <7.0%
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 3 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years
Time Frame: 3 years
|
3 years
|
|
hypoglycemia rate
Time Frame: 3 years
|
will be measured as absolute event rate per patient year of follow up
|
3 years
|
change in the FPG
Time Frame: 3 years
|
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
Time Frame: 3 years
|
change in body weight from time zero to 1 year and to 3 years in each treatment group
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amin Jayyousi, MD, HMC
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPRP 5-273-3-079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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