Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Drug: insulin glargine and insulin aspart; Drug: Pioglitazone plus exenatide

• Registration Number: NCT02887625
• Lead Sponsor: Dr. Muhammad Abdulghani

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%

Study Timeline

• Study Start: 2015-02
• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-29
• Last Update Submitted: 2016-08-29
• Study First Posted: 2016-09-02
• Last Update Posted: 2016-09-02
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 410

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Therapy	insulin glargine and insulin aspart	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
Combination Therapy	Pioglitazone plus exenatide	pioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hamad General Hospital; 🇶🇦 Doha, Qatar