Type 2 DiabetesNCT02887625
Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM
A study testing Pioglitazone plus exenatide and insulin glargine and insulin aspart in people with Type 2 Diabetes, run by Dr. Muhammad Abdulghani at 1 site in Qatar.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pioglitazone plus exenatide and insulin glargine and insulin aspart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteQatar
- Study dates
- Feb 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2DM poorly controlled (HbA1c >7.5%) on metformin (>1700 mg/day) plus sulfonylurea
Who cannot join
- type 1 diabetes (T1DM) patients receiving therapy with pioglitazone, GLP-1 RA and insulin abnormal kidney, liver or heart function patients with malignancy
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad General Hospital
Doha
Osama Mujahed, MD, 66703172, pvedromigahid@gmail.com
Ayman Mujahed, MD, 44391208, ymndodo20@gmail.com
About this study
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
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:
- exenatide weekly injection (2 mg/week)
- glargine insulin plus insulin aspart which will be titrated to maintain HbA1c <7.0%
- Conditions
- Type 2 Diabetes
- Being tested
- Pioglitazone plus exenatide, insulin glargine and insulin aspart
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone plus exenatideDrug
Also called actos and bydureon
pioglitazone will be started at 30 mg/day and bydureon at 2 mg/week
insulin glargine and insulin aspartDrug
Also called lantus
the dose will be escalated to maintain HbA1c <7.0%
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | pioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week Receives: Drug: Pioglitazone plus exenatide |
| Insulin Therapy | Active comparator | 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 Receives: Drug: insulin glargine and insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (4)
percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years
Measured: 3 years
hypoglycemia rate
will be measured as absolute event rate per patient year of follow up
Measured: 3 years
change in the FPG
change in FPG from time zero to 1 year and from baseline to 3 years in each treatment group
Measured: 3 years
change in body weight
change in body weight from time zero to 1 year and to 3 years in each treatment group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Muhammad Abdulghani
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Dr. Muhammad Abdulghani, Hamad Medical Corporation
- Investigators
- Amin Jayyousi, MD, Principal investigator, HMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887625
- Sponsor's protocol ID
- NPRP 5-273-3-079
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 28096223
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02887625
- Acronym / sponsor ID
- NPRP 5-273-3-079
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Dr. Muhammad AbdulghaniIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- exenatide weekly injection (2 mg/week)
- glargine insulin plus insulin aspart which will be titrated to maintain HbA1c <7.0%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Drug: Pioglitazone plus exenatidepioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week |
| Insulin Therapy | Active comparator | Drug: insulin glargine and insulin aspartinsulin 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- T2DM poorly controlled (HbA1c >7.5%) on metformin (>1700 mg/day) plus sulfonylurea
Key exclusion criteria (1 listed)
- type 1 diabetes (T1DM) patients receiving therapy with pioglitazone, GLP-1 RA and insulin abnormal kidney, liver or heart function patients with malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone plus exenatideAlso: actos and bydureonpioglitazone will be started at 30 mg/day and bydureon at 2 mg/week | Drug | Combination Therapy |
| insulin glargine and insulin aspartAlso: lantusthe dose will be escalated to maintain HbA1c <7.0% | Drug | Insulin Therapy |
Primary outcome
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
4 secondary outcomes
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
change in the FPG
Time frame: 3 years
change in body weight
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Derived from this study: PubMed 28096223Abdul-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amin Jayyousi, MD principal investigator
HMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pioglitazone plus exenatide and insulin glargine and insulin aspart in people with Type 2 Diabetes, run by Dr. Muhammad Abdulghani at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Abdul-Ghani, MD, PhD (44391208, ABDULGHANI@UTHSCSA.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02887625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.