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
1 other identifier
interventional
410
1 country
1
Brief Summary
To compare efficacy, safety and durability of combination therapy with pioglitazone plus GLP-1 RA versus basal bolus insulin in poorly controlled T2DM patients on metformin plus sulfonylurea
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Feb 2015
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
September 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedSeptember 2, 2016
August 1, 2016
2.2 years
August 16, 2016
August 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years
3 years
hypoglycemia rate
3 years
change in the FPG
3 years
change in body weight
3 years
Study Arms (2)
Combination Therapy
EXPERIMENTALpioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week
Insulin Therapy
ACTIVE COMPARATORinsulin 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
Interventions
pioglitazone will be started at 30 mg/day and bydureon at 2 mg/week
the dose will be escalated to maintain HbA1c \<7.0%
Eligibility Criteria
You may qualify if:
- T2DM poorly controlled (HbA1c \>7.5%) on metformin (\>1700 mg/day) plus sulfonylurea
You may not qualify if:
- type 1 diabetes (T1DM) patients receiving therapy with pioglitazone, GLP-1 RA and insulin abnormal kidney, liver or heart function patients with malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hamad General Hospital
Doha, Qatar
Related Publications (1)
Abdul-Ghani M, Migahid O, Megahed A, Adams J, Triplitt C, DeFronzo RA, Zirie M, Jayyousi A. Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Metformin: The Qatar Study. Diabetes Care. 2017 Mar;40(3):325-331. doi: 10.2337/dc16-1738. Epub 2017 Jan 17.
PMID: 28096223DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amin Jayyousi, MD
HMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
August 16, 2016
First Posted
September 2, 2016
Study Start
February 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
September 2, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share