Primary outcome
What PIO-EX measured first
| PIOGLITAZONEn=10 | EXENATIDEn=11 | PIOGLITAZONE and EXNATIDEn=9 |
|---|---|---|
| 5.5(7.3) | 2.4(2.8) | 2.7(4.4) |
| Pioglitazonen=10 | Exenatiden=11 | Drug Pioglitazone and Drug Exentatiden=9 |
|---|---|---|
| 1.37(0.68) | 1.09(0.68) | 1.91(1.20) |
Phase 4 · Exenatide
PIO-EX trial results
Effect of Pioglitazone With and Without Exenatide on Body Weight, Fat Topography, Beta Cell Function, and Glycemic Control in Type 2 Diabetic Patients
Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight (kg), baseline and 6 months. PIOGLITAZONE: 5.5; EXENATIDE: 2.4; PIOGLITAZONE and EXNATIDE: 2.7.
- Participants
- 43
- Status
- completed
- Completed
- 2010-07
- Sponsor
- The University of Texas Health Science Center at San Antonio
As posted on ClinicalTrials.gov (NCT00845182), updated at source Jan 18, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in PIO-EX
Percent of participants affected, Patients were followed for 6 months.. The most common events the registry lists.
| Event | Pioglitazone | Exenatide | Pioglitazone and Exentatide |
|---|---|---|---|
| Any serious event | 0% | 0% | 0% |
| weight gain | 16.7% | 0% | 6.7% |
| nausea | 0% | 6.7% | 0% |
The trial
How PIO-EX was run
Pioglitazone, a drug used in treatment of type 2 diabetes has been shown to improve insulin sensitivity in skeletal muscle, liver, and fat cells. Despite the beneficial effects of pioglitazone to improve insulin sensitivity and reduce cardiovascular disease in high risk type 2 diabetic patients, weight gain has been a limiting factor. Exenatide, another agent used for treatment of T2DM, improves glycemic control and promotes moderate weight loss. In this proposal we will examine the effect of combination therapy with pioglitazone plus exenatide on body weight, fat topography, beta cell function, glycemic control, and plasma lipid levels in subjects with type 2 diabetes mellitus compared to treatment with each drug separately. Assessment of beta cell function will be performed by measuring the maximal insulin secretory capacity using a maximal hyperglycemic stimulus combined with an intravenous arginine stimulus.
- Pioglitazone: Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
- Exenatide: Exenatide: 15 subjects will be randomized to receive Exenatide
- Drug Pioglitazone and Drug Exentatide: Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
Who could join the trial
Inclusion Criteria: 1. Diabetic patients must be on diet therapy alone or diet plus a sulfonylurea, or diet plus metformin, or diet plus sulfonylurea/metformin and have a HbA1c ≥ 7.0%. 2. Patients must have the following laboratory values: Hematocrit ≥ 34 vol% Serum creatinine ≤ 1.8 mg/dl AST (SGOT) ≤ 2 times upper limit of normal ALT (SGPT) ≤ 2 times upper limit of normal Alkaline phosphatase ≤ 2 times upper limit of normal 3. Patients must have been on a stable dose of allowed chronic medications for 30 days prior to entering the study. 4. Body weight must be stable (± 3-4 pounds) over the three months prior to study 5. The normal healthy control group will be age, weight (BMI), and gender matched with the diabetic group and must have a normal OGTT according to ADA criteria. 6. Subjects with IFG/IGT will have a FPG (100-125mg/dl) and/or 2-h plasma glucose (140-199mg/dl) according to ADA criteria. Exclusion Criteria: 1. Patients must not have type 1 diabetes. 2. Patients must not have a fasting plasma glucose of greater than 270 mg/dl or HbA1c \> 10.0%. 3. Patients must not have received a thiazolidinedione or insulin for more than one week during the year prior to randomization. 4. Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2.
Published papers
Papers from PIO-EX
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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