Overweight

Pre Diabetes

Diabetes Mellitus Type 2 Without Complication

This was a cross-sectional study in which participants were subjected to a screening phase before being eligible to participate in the study. All subjects were submitted to Laser-Doppler methods (assessment of microcirculatory blood flow), bioimpedance analysis (assessment of body composition), venous blood collections (laboratory analysis), and Finometer Pro (assessment of heart rate variability and blood pressure variability).

Laser-Doppler methods

DPP4 Activity, Microvascular Reactivity and Inflammation

Dipeptidyl Peptidase 4 (DPP4) Activity and Its Associations With Endothelial Dysfunction, Inflammatory and Metabolic Markers, Heart Rate and Blood Pressure Variability, and Measures of Adiposity in Subjects With Different Grades of Glucose Tolerance

Intergroup analysis of the associations between DPP4 activity and skin microvascular reactivity (blood flux and vasomotion evaluated by Laser-Doppler methods) - baseline assessment and at 30 and 60 min after a standardized meal intake (ingested over 3 minutes)

Intergroup analysis of the associations between DPP4 activity and markers of inflammation - baseline assessment and at 30 and 60 min after a standardized meal intake (ingested over 3 minutes)

Intergroup comparisons between the associations of DPP4 activity and Biochemical parameters (including gut peptides) - baseline assessment and at 30 and 60 min after a standardized meal intake (ingested over 3 minutes)

Intergroup analysis of the associations between DPP4 activity and insulin resistance indexes, heart rate and blood pressure variability (evaluated by Finometer Pro), and measures of adiposity at baseline

Luiz Guilherme Kraemer-Aguiar, MD

Professor

Rio de Janeiro State University

Dipeptidyl-peptidase-4

STEMI

No-reflow

Bleeding

Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding

TIMI flow grade of <3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow

the composite of death, nonfatal MI, or stroke

defined as acute heart failure, atrial fibrillation, chest pain or re-acute myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia

defined as absolute hemoglobin drop (baseline to nadir)≥4g/dl, intracranial hemorrhage, retroperitoneal hemorrhage, use of red blood cell transfusion in patients with a baseline hemoglobin ≥9.0 g/dl, and use of red blood cell transfusion among patients with a baseline hemoglobin <9.0 g/dl and a witnessed bleeding event

Li Jing Wei

Chinese PLA General Hospital

The patients received pioglitazone hydrochloride tablet 30 mg (001 drug)once daily for first three months

The patients received metformin hydrochloride tablet 850 mg (002 drug)once daily for next three months.

This was double blind, single group and "within subjects" designed study with two interventions.We screened 130 patients, selected 77 subjects who received drug Code 001, then gone through one month wash out period, then received Code 002.For PPARγ genotyping blood samples were collected from patients. There were found two groups-Pro12Pro and Pro12Ala. Baseline evaluation included detailed medical history,socioeconomic status, physical examination, and laboratory investigations for biomedical variables,psychosocial factors according to Patient Health Questionnaire (PHQ-9) and WHO-5 questionnaires.We decoded blinded drug after analyzing the results and knew that pioglitazone (30 mg once daily) was coded as 001 and metformin (850 mg once daily) as code 002.
For statistical analysis we compare Pio vs Met, Pro12Pro vs Pro12Ala, met responder vs non responder.

Single Group Study With Two Interventions

Sex: Female, Male

Region of Enrollment

Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.
Analysis 1:Total Cholesterol(TC) Analysis 2:Triglyceride(TG) Analysis 3:High Density Lipoprotein(HDL) Analysis 4:Low Density Lipoprotein(LDL)

Dose: Pioglitazone tablet 30 mg once daily for 3 months

Pioglitazone (001 Group)

Dose: Metformin tablet 850 mg once daily for 3 months

Metformin (002 Group)

Comparison of Changes in Lipid Profiles With Pioglitazone and Metformin

Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.

Dose: Pioglitazone tablet 30mg once daily for 3 months.

Metformin ( 002 Group)

Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin

Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin

Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.
Analysis 1: Homeostasis Model Assessment Insulin Resistance(HOMA IR) Analysis 2: Quantitative Insulin sensitivity Check Index(QUICKI)

Comparison of Changes in Insulin Levels (HOMA IR,QUICKI) With Pioglitazone and Metformin

Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.
Analysis 1: Homeostatic Model Assessment of Beta cell function(HOMA percent B) Analysis 2: Homeostatic Model Assessment of Insulin Sensitivity (Homa percent S)

Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin

Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin

Group 001-Pioglitazone 30 mg tablet once daily Group 002-Metformin 850 mg tablet once daily
The single group study with a wash out period of one month with metformin 850 mg tablet once daily.
77 patients started with pioglitazone(7 drop out)and after one month wash out period 70 patients started with metformin (9 drop out).
48 patients for the 1st 3 months of pioglitazone and 32 patients for the 2nd 3 months of metformin responded to the drugs respectively according to the response rate[The treatment target was set to reduce at least ≥10% FBG or ≥1% HbA1c in the patients considering as the responder group].

Single Group Study With Two Drugs- Pioglitazone and Metformin

001 (Pioglitazone) -3 Months

002 (Metformin)-3 Months

Dr. Masuma Parvin

77 patients received the drug pioglitazone (30mg/day) for 3 months. Adverse events were assessed non-systematically on patients' complain generally and also systematically in case of hypertension, weight gain, common depression [Patient Health Questionnaire (PHQ-9) method] and creatinine increase.
No serious adverse event was found during pioglitazone trial.
In case of other adverse event, one patient complained for peripheral edema which disappeared (without medicine) within 2 days at the 2nd month of the treatment, Four patients gained weight within 10% of their initial weight after 3 months of the treatment and two patients complained for abdominal discomfort in the 1st month and normal treatment with antacid was provided to them.

After wash out period 70 patients started with metformin (850mg/day) for further 3 months. Adverse events were assessed non-systematically on patients' complain and also systematically in case of hypertension, weight gain, common depression (PHQ-9 method) and creatinine increase.
On basis of systemic data review and patient complain one patient was found with hypertension and another one was with increased creatinine level at the end of the metformin treatment and these events were assumed as serious adverse events as they were at health risk and withdrawn from the trial for intervention by hospital physician though they didn't need for hospitalization.
One patient complained for mild diarrhea in the first month of the metformin treatment, the patient needed necessary treatment according to doctor's advice for one day, Five patients complained for abdominal discomfort in the 1st month and antacid was provided. Six patients were assumed suffering from common depression.

Type 2 Diabetes Mellitus

77 patients were treated with pioglitazone hydrochloride (B001) for 3 months.Biomedical parameters were measured each month.

Pioglitazone hydrochloride

After the treatment with pioglitazone(001) for 3 months first and then patients were on one month washout period;in the washout period they were given metformin tablet 850mg once daily,then treated with 002 (metformin) for further 3 months. The same biomedical measurements were assayed.

Metformin hydrochloride

Bangladesh Institute of Research & Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM)

Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM)

Efficacy Study of Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor Gamma Gene Variants in Bangladeshi Type 2 Diabetes Mellitus Subjects

Modulation of Insulin Secretion and Insulin Sensitivity in Bangladeshi Type 2 Diabetic Subjects by an Insulin Sensitizer Pioglitazone and T2DM Association With PPARG Gene Polymorphism.

Research fellow

University of Dhaka

Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

University of Dundee

45 mg tablet daily by mouth for six weeks

Pioglitazone

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.

Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue

Apoptotic index (A1) will be assessed by terminal deoxynucleotidyl transferase dUTP end labeling (TUNEL) and cyclin D1, p21/Waf1, PPARy, MUC1, gelsolin, proline oxidase, and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) will be assessed by immunohistochemistry.

Number of Participants With Effects of Pioglitazone on Multiple Biomarkers in Tumor

Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.

Number of Participants With Adverse Events

Response will be evaluated by FDG-PET. Response is defined as a decrease of standardized uptake values (SUV) of more than one.

Number of Participants With Metabolic Activity Determined by Fludeoxyglucose Positron-emission Tomography (FDG-PET)

Premalignant tissue biomarkers ki-67, apoptotic index and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.

Number of Participants With Effects of Pioglitazone on Premalignant Tissue Biomarkers

ki-67 and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.

Number of Participants With Effects of Pioglitazone on Histologically Normal Tissue Biomarkers

C-reactive protein, cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA-125) and carcinoembryonic antigen (CEA) will be assessed by immunohistochemistry.

diabetes mellitus type 2/proline

DPP4 Activity, Microvascular Reactivity and Inflammation

Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding

Efficacy Study of Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor Gamma Gene Variants in Bangladeshi Type 2 Diabetes Mellitus Subjects

Pioglitazone to Treat Adults Undergoing Surgery for Non-small Cell Lung Cancer

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