Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02887625
• Other study ID #: NPRP 5-273-3-079
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 29, 2016
• Start date: February 2015
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: Hamad Medical Corporation
• Contact: Muhammad Abdul-Ghani, MD, PhD
• Phone: 44391208
• Email: ABDULGHANI[@]UTHSCSA.EDU
• Is FDA regulated: No
• Health authority: Qatar: Supreme Council Of Health
• Study type: Interventional

Clinical Trial 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

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%

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Pioglitazone plus exenatide
pioglitazone will be started at 30 mg/day and bydureon at 2 mg/week
• insulin glargine and insulin aspart
the dose will be escalated to maintain HbA1c <7.0%

Locations

Country	Name	City	State
Qatar	Hamad General Hospital	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Muhammad Abdulghani

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
Secondary	percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years		3 years	No
Secondary	hypoglycemia rate	will be measured as absolute event rate per patient year of follow up	3 years	Yes
Secondary	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	No
Secondary	change in body weight	change in body weight from time zero to 1 year and to 3 years in each treatment group	3 years	No