Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM

NCT ID: NCT02887625

Last Updated: 2016-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-05-31

Brief Summary

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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

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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%

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination Therapy

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

Group Type EXPERIMENTAL

Pioglitazone plus exenatide

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

insulin glargine and insulin aspart

Intervention Type DRUG

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

Interventions

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Pioglitazone plus exenatide

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

Intervention Type DRUG

insulin glargine and insulin aspart

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

Intervention Type DRUG

Other Intervention Names

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actos and bydureon lantus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Muhammad Abdulghani

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr. Muhammad Abdulghani

Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Amin Jayyousi, MD

Role: PRINCIPAL_INVESTIGATOR

HMC

Locations

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Hamad General Hospital

Doha, , Qatar

Site Status RECRUITING

Countries

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Qatar

Central Contacts

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Muhammad Abdul-Ghani, MD, PhD

Role: CONTACT

Amin Jayyousi, MD

Role: CONTACT

Facility Contacts

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Osama Mujahed, MD

Role: primary

Ayman Mujahed, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 28096223 (View on PubMed)

Other Identifiers

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NPRP 5-273-3-079

Identifier Type: -

Identifier Source: org_study_id

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