Primary outcomeMean· baseline and 6 months
Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight
| Group | Value (kg) | Spread |
|---|---|---|
| PIOGLITAZONE | 5.5 | 7.3 |
| EXENATIDE | 2.4 | 2.8 |
| PIOGLITAZONE and EXNATIDE | 2.7 | 4.4 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataEffect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function
Short name PIO-EX
NCTNCT00845182 (opens ClinicalTrials.gov in a new tab)Other idHSC2007243H
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 43 participants (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- Jun 2007
- Primary completion
- Jul 2010
- Completion
- Jul 2010
- First posted
- 18 Feb 2009 (estimated)
- Last update posted
- 18 Jan 2018
- Conditions
- Type 2 Diabetes · Healthy · Impaired Glucose Tolerance
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20072008200920102011
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- PioglitazoneDrug
- ExenatideDrug
- Pioglitazone and ExenatideDrug
Arms3
Active comparator
Pioglitazone
Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
Experimental
Exenatide
Exenatide: 15 subjects will be randomized to receive Exenatide
Experimental
Drug Pioglitazone and Drug Exentatide
Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
Primary outcomes2
Outcomes the sponsor listed as primary.
Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight
Time frame · baseline and 6 months
Registry description
Effect of Pioglitazone, Exenatide and combined Pioglitazone and Exenatide on body weight and beta cell function
HbA1c
Time frame · baseline and 6 months
Registry description
change in HbA1c was measured before and after treatment in three groups
Secondary outcomes(1)
Effect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatide • Insulin Sensitivity • Inflammatory Cytokines • Glucagon and Free Fatty Acids • Plasma Lipids
Time frame · 6 months
Registry description
Effect pioglitazone, exenatide, and pioglitazone plus exenatide on * Insulin sensitivity * Inflammatory cytokines * glucagon and free fatty acids * plasma lipids measured over a 6 month period
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· baseline and 6 months
HbA1c
| Group | Value (percent point decrease from baseline) | Spread |
|---|---|---|
| Pioglitazone | 1.37 | 0.68 |
| Exenatide | 1.09 | 0.68 |
| Drug Pioglitazone and Drug Exentatide | 1.91 | 1.20 |
Secondary and other outcome results(1)
Secondary outcome· 6 months
Effect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatide • Insulin Sensitivity • Inflammatory Cytokines • Glucagon and Free Fatty Acids • Plasma Lipids
| Group | Value |
|---|---|
| Effect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatid | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PioglitazonePioglitazone: 15 Patients will be randomized to Pioglitazone only arm | – | 0 / 12 | 2 / 12 |
| ExenatideExenatide: 15 subjects will be randomized to receive Exenatide | – | 0 / 15 | 1 / 15 |
| Pioglitazone and ExentatidePioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide | – | 0 / 15 | 1 / 15 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedGuardado-Mendoza R, Chavez AO, Jimenez-Ceja LM, Hansis-Diarte A, DeFronzo RA, Folli F, Tripathy D. Islet amyloid polypeptide response to maximal hyperglycemia and arginine is altered in impaired glucose tolerance and type 2 diabetes mellitus. Acta Diabetol. 2017 Jan;54(1):53-61. doi: 10.1007/s00592-016-0904-7. Epub 2016 Sep 13. PMID 27624579
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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.
PepBank is a research reference. Talk to a doctor before you use any peptide.