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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy | Experimental | pioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone plus exenatide | Drug | pioglitazone will be started at 30 mg/day and bydureon at 2 mg/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years | 3 years | |
| hypoglycemia rate | will be measured as absolute event rate per patient year of follow up | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Abdul-Ghani, MD, PhD | Contact | 44391208 | ABDULGHANI@UTHSCSA.EDU | |
| Amin Jayyousi, MD | Contact | 55530236 | ajayyousi@hamad.qa |
| Name | Affiliation | Role |
|---|---|---|
| Amin Jayyousi, MD | HMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad General Hospital | Recruiting | Doha | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28096223 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D000077270 | Exenatide |
| D000069036 | Insulin Glargine |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| insulin glargine and insulin aspart | Drug | the dose will be escalated to maintain HbA1c <7.0% |
|
|
| change in the FPG | 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 | change in body weight from time zero to 1 year and to 3 years in each treatment group | 3 years |
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D061266 | Insulin, Short-Acting |