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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02887625

Enrollment

410

Registered

2016-09-02

Start date

2015-02-28

Completion date

2017-05-31

Last updated

2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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

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: 1. exenatide weekly injection (2 mg/week) 2. glargine insulin plus insulin aspart which will be titrated to maintain HbA1c \<7.0%

Interventions

DRUGPioglitazone plus exenatide

pioglitazone will be started at 30 mg/day and bydureon at 2 mg/week

DRUGinsulin glargine and insulin aspart

the dose will be escalated to maintain HbA1c \<7.0%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
HbA1c	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

Secondary

Measure	Time frame	Description
percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years	3 years	—
hypoglycemia rate	3 years	will be measured as absolute event rate per patient year of follow up
change in the FPG	3 years	change in FPG from time zero to 1 year and from baseline to 3 years in each treatment group
change in body weight	3 years	change in body weight from time zero to 1 year and to 3 years in each treatment group

Countries

Qatar

Contacts

Primary ContactMuhammad Abdul-Ghani, MD, PhD

ABDULGHANI@UTHSCSA.EDU44391208

Backup ContactAmin Jayyousi, MD

ajayyousi@hamad.qa55530236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026