| Trial ID: | L6822 |
| Source ID: | NCT01589445
|
| Associated Drug: |
Pioglitazone Hydrochloride
|
| Title: |
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
|
| Acronym: |
T2DMCT
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01589445/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Pioglitazone hydrochloride|DRUG: Metformin hydrochloride
|
| Outcome Measures: |
Primary: Comparison of Changes in Fasting Serum Glucose (FSG)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., 3 months for each drug|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., 3 months for each drug|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: Homeostasis Model Assessment Insulin Resistance(HOMA IR) Analysis 2: Quantitative Insulin sensitivity Check Index(QUICKI), 3 months for each drug|Comparison of Changes in HOMA Percent B and HOMA Percent S 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), 3 months for each drug|Comparison of Changes in Fasting Serum Insulin (FSI)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., 3 months for each drug | Secondary: 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. Analysis 1:Total Cholesterol(TC) Analysis 2:Triglyceride(TG) Analysis 3:High Density Lipoprotein(HDL) Analysis 4:Low Density Lipoprotein(LDL), 3 months for each drug
|
| Sponsor/Collaborators: |
Sponsor: University of Dhaka | Collaborators: Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders|University of Dundee
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
77
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-11
|
| Completion Date: |
2010-06
|
| Results First Posted: |
2014-02-27
|
| Last Update Posted: |
2014-02-28
|
| Locations: |
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM), Dhaka, 1000, Bangladesh
|
| URL: |
https://clinicaltrials.gov/show/NCT01589445
|
