Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM

August 29, 2016 updated by: Dr. Muhammad Abdulghani

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

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

Study Overview

Status

Unknown

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:

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

Study Type

Interventional

Enrollment (Anticipated)

410

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Muhammad Abdulghani

Investigators

  • Principal Investigator: Amin Jayyousi, MD, HMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

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)?

NO

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.

Subscribe