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PIO-EX
CompletedPhase 4Results postedEffect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function
Effect of Pioglitazone With and Without Exenatide on Body Weight, Fat Topography, Beta Cell Function, and Glycemic Control in Type 2 Diabetic Patients
Asset
Exenatide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
43
actual
Study population
Healthy volunteers, Prediabetes / glucose intolerance, Type 2 diabetes
Key I/E criteria
•HbA1c ≥7%•Healthy volunteers
Primary endpoints
•Body weight, absolute change (kg)•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (3)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointEffect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight
Time frame:baseline and 6 months
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| PIOGLITAZONE | 5.5 | — |
| EXENATIDE | 2.4 | — |
| PIOGLITAZONE and EXNATIDE | 2.7 | — |
Glycemic / diabetes
1 endpointHbA1c
Time frame:baseline and 6 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), percent point decrease from baseline | 95% CI |
|---|---|---|
| Pioglitazone | 1.37 | — |
| Exenatide | 1.09 | — |
| Drug Pioglitazone and Drug Exentatide | 1.91 | — |
Other (unclassified)
1 endpointEffect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatide • Insulin Sensitivity • Inflammatory Cytokines • Glucagon and Free Fatty Acids • Plasma Lipids
Time frame:6 months
change from baseline, improvement
componentsHOMA-IR (insulin sensitivity), hs-CRP, change, Free fatty acids, change, Triglycerides, change, LDL-C, change, HDL-C, change, Total cholesterol, change
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Acta diabetologica2017 Jan (month)PMID27624579doi:10.1007/s00592-016-0904-7via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.