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Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM

This study is currently recruiting participants.
Verified August 2016 by Dr. Muhammad Abdulghani, Hamad Medical Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02887625
First Posted: September 2, 2016
Last Update Posted: September 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Muhammad Abdulghani, Hamad Medical Corporation
  Purpose
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

Condition Intervention
Type 2 Diabetes Drug: Pioglitazone plus exenatide Drug: insulin glargine and insulin aspart

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr. Muhammad Abdulghani, Hamad Medical Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years [ Time Frame: 3 years ]
  • hypoglycemia rate [ Time Frame: 3 years ]
    will be measured as absolute event rate per patient year of follow up

  • 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

  • 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


Estimated Enrollment: 410
Study Start Date: February 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: lantus

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%
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887625


Contacts
Contact: Muhammad Abdul-Ghani, MD, PhD 44391208 ABDULGHANI@UTHSCSA.EDU
Contact: Amin Jayyousi, MD 55530236 ajayyousi@hamad.qa

Locations
Qatar
Hamad General Hospital Recruiting
Doha, Qatar
Contact: Osama Mujahed, MD    66703172    pvedromigahid@gmail.com   
Contact: Ayman Mujahed, MD    44391208    ymndodo20@gmail.com   
Sponsors and Collaborators
Dr. Muhammad Abdulghani
Investigators
Principal Investigator: Amin Jayyousi, MD HMC
  More Information

Responsible Party: Dr. Muhammad Abdulghani, Professor of Medicine, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT02887625     History of Changes
Other Study ID Numbers: NPRP 5-273-3-079
First Submitted: August 16, 2016
First Posted: September 2, 2016
Last Update Posted: September 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Insulin, Globin Zinc
Pioglitazone
Exenatide
Insulin
Insulin Glargine
Insulin Aspart
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists