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Status unknownNCT02887625Updated Sep 2, 2016

Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM

An interventional study of Pioglitazone plus exenatide and insulin glargine and insulin aspart in Type 2 Diabetes, sponsored by Dr. Muhammad Abdulghani. Status unknown at 1 site in Qatar. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-02.

Sponsored by Dr. Muhammad Abdulghani · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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%
02

Conditions studied

  • Type 2 Diabetes
03

In context

Lead sponsor

This is the only study on the registry with Dr. Muhammad Abdulghani as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • T2DM poorly controlled (HbA1c >7.5%) on metformin (>1700 mg/day) plus sulfonylurea

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
410 participants (estimated)

Study arms

  • Experimental
    Combination Therapy

    pioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week

    Drug: Pioglitazone plus exenatide

  • 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

Interventions

  • DrugPioglitazone plus exenatide

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

    Also known as: actos and bydureon

  • Druginsulin glargine and insulin aspart

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

    Also known as: lantus

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years

Secondary outcomes

  1. percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years

    Time frame: 3 years

  2. hypoglycemia rate

    will be measured as absolute event rate per patient year of follow up

    Time frame: 3 years

  3. change in the FPG

    change in FPG from time zero to 1 year and from baseline to 3 years in each treatment group

    Time frame: 3 years

  4. change in body weight

    change in body weight from time zero to 1 year and to 3 years in each treatment group

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Abdul-Ghani M, Migahid O, Megahed A, Adams J, Triplitt C, DeFronzo RA, Zirie M, Jayyousi A. Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Metformin: The Qatar Study. Diabetes Care. 2017 Mar;40(3):325-331. doi: 10.2337/dc16-1738. Epub 2017 Jan 17. Erratum In: Diabetes Care. 2017 Aug;40(8):1134. doi: 10.2337/dc17-er08d. PubMed 28096223 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02887625
Lead sponsor
Dr. Muhammad Abdulghani
Responsible party
Dr. Muhammad Abdulghani (Professor of Medicine, Hamad Medical Corporation) — Sponsor-investigator
First posted
Sep 2, 2016
Start date
Feb 2015
Primary completion
May 2017 (estimated)
Completion
May 2017 (estimated)
Last update
Sep 2, 2016

Study contacts

Muhammad Abdul-Ghani, MD, PhD
Contact
ABDULGHANI@UTHSCSA.EDU
44391208
Amin Jayyousi, MD
Contact
ajayyousi@hamad.qa
55530236
Amin Jayyousi, MD
principal investigator · HMC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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