1. Name the study and provide a link 

The name of this study is “Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor Gamma Gene Variants in Bangladeshi Type 2 Diabetes Mellitus Subjects (T2DMCT).” (Link is in the bottom). 

2. Describe the aims of the study. 

The aim of this study is to assess the efficacy and safety of two different insulin sensitizers which are Pioglitazone and Metformin. In addition, it’s taken subjects of type two diabetes in Bangladesh. This study was conducted between November 2008 and September 2010.

3. Is the study of a clinical trial (aka an interventional study) or an observational study? (Both kinds of study are listed at ClinicalTrials.gov.) If a clinical trial, what are its research plan, and what is its protocol? 

This is a clinical trial (interventional study). A prospective, double-blind, single group, ‘within-subject’ designed clinical trial of 77 diagnosed T2DM patients out of 130 patients with glycosylated hemoglobin between ages 46 through 64. 

4. Who is the study’s lead investigator? Who makes up their team (even if names aren’t given, it should be listed whether they are doctors, social workers, scientists, etc)?

The study’s lead investigator is AK Azad Chowdhury, the Principal Investigator is Masuma Parvin, and the two study director are Begum Rokeya and Colin Palmer. All obtained their Ph.D. either at the University of Dhaka, Bangladesh, University of Dundee, or BIRDEM, Dhaka, Bangladesh. 

5. Who is sponsoring or funding the study?

The sponsors for this clinical trial are the University of Dhaka, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorder, and the University of Dundee. 

6. What is the study’s recruitment status? Has the study been evaluated by the US federal government?  

For this study, the study’s recruitment status was completed. However, the study has not been evaluated by the US federal government. 

7. Describe the procedures of the study.

There was a double-blind and single group within this designed trial. It diagnosing 77 T2DM patients out of 130 patients with glycosylated hemoglobin ages between 46 through 64. In addition, they had to be registered for diabetes treatment I Bangladesh Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorder. To go on with the data, it includes patients history, anthropometric measurement, and biomedical parameters psychosocial factors to not only enroll but to also receive treatment with 001 drug once daily for three months. The patients then will have been left for washout for metformin 850mg once daily for one month and then will receive 002 drug once daily for a further three months. The purpose of this study is to find a treatment.

Results: In a total of the five studies, they all showed the same results. 

• Comparison of Changes in Fasting Serum Glucose (FSG) With Pioglitazone and Metformin (time frame: 3 months for each drug) ~ A ten percent decrease as well of FSG after 3 months of treatment. 
• Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin (time rame: 3 months for each drug) ~ A ten percent decrease as well of FSG after 3 months of treatment. 
• Comparison of Changes in Insulin Levels (HOMA IR, QUICKI) With Pioglitazone and Metformin (time Frame: 3 months for each drug)~ A ten percent decrease as well of FSG after 3 months of treatment. 
• Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin (time Frame: 3 months for each drug) ~ A ten percent decrease as well of FSG after 3 months of treatment. 
• Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin (time frame: 3 months for each drug) ~ A ten percent decrease as well of FSG after 3 months of treatment.

Link:https://clinicaltrials.gov/ct2/show/study/NCT01589445?cond=Diabetes&cntry=BD&draw=2&rank=3