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Trial record 1 of 2 for:    15618111 [PUBMED-IDS]
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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 (T2DMCT)

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ClinicalTrials.gov Identifier: NCT01589445
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : February 27, 2014
Last Update Posted : February 28, 2014
Sponsor:
Collaborators:
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
University of Dundee
Information provided by (Responsible Party):
Dr. Masuma Parvin, University of Dhaka

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Pioglitazone hydrochloride
Drug: Metformin hydrochloride
Enrollment 77
Recruitment Details

Location: Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM),Dhaka, Bangladesh and National Forensic DNA Profiling Laboratory, Dhaka Medical College, Dhaka.

Recruitment of patients were started at November 2008 and ended at December 2010.

Pre-assignment Details 130 Type 2 Diabetes Mellitus (T2DM) out door patients of BIRDEM were screened to participate in the study.80 patients signed consent form and 77 enrolled the trial.3 patients didn't participate due to unknown cause.The patients were directed to follow their routine diet chart as before.
Arm/Group Title Single Group Study With Two Drugs- Pioglitazone and Metformin
Hide Arm/Group Description

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].

Period Title: 001 (Pioglitazone) -3 Months
Started 77
Completed 70 [1]
Not Completed 7
Reason Not Completed
Protocol Violation             1
Withdrawal by Subject             1
Lost to Follow-up             2
Lack of Efficacy             1
biasedness about the double blind method             2
[1]
dropped out 7 patients
Period Title: 002 (Metformin)-3 Months
Started 70 [1]
Completed 61 [2]
Not Completed 9
Reason Not Completed
Lack of Efficacy             1
Lost to Follow-up             2
Protocol Violation             2
Adverse Event             2
Husbands of female patients refrained             2
[1]
70 patients participated for trial of drug 002.
[2]
61 patients completed the drug 002.9 patients dropped out.
Arm/Group Title Single Group Study With Two Interventions
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants
<=18 years
0
   0.0%
Between 18 and 65 years
77
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants
46  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants
Female
47
  61.0%
Male
30
  39.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Bangladesh Number Analyzed 77 participants
77
1.Primary Outcome
Title Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin
Hide Description 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.
Time Frame 3 months for each drug
Hide Outcome Measure Data
Hide Analysis Population Description
After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.
Arm/Group Title Pioglitazone (001 Group) Metformin ( 002 Group)
Hide Arm/Group Description:
Dose: Pioglitazone tablet 30mg once daily for 3 months.
Dose: Metformin tablet 850 mg once daily for 3 months
Overall Number of Participants Analyzed 48 32
Mean (Standard Deviation)
Unit of Measure: mmol/l
Baseline FSG 6.9  (2.5) 6.2  (1.6)
3rd Month FSG 5.4  (1.2) 6.5  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin ( 002 Group)
Comments Change from Baseline in FSG at 3rd month
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, Multiple Logistic Regression (MLR), OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-7.9 to 8.0
Parameter Dispersion
Type: Standard Deviation
Value: 2.41
Estimation Comments The group 001 was divided according to Pro12Pro and Pro12Ala groups.There was no Ala12Ala group.These two groups were compared also in accordance with all parameters (glycemic levels, insulin levels, lipid profiles, BMI).
2.Primary Outcome
Title Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin
Hide Description 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.
Time Frame 3 months for each drug
Hide Outcome Measure Data
Hide Analysis Population Description
After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.
Arm/Group Title Pioglitazone (001 Group) Metformin ( 002 Group)
Hide Arm/Group Description:
Dose: Pioglitazone tablet 30 mg once daily for 3 months
Dose: Metformin tablet 850 mg once daily for 3 months
Overall Number of Participants Analyzed 48 32
Mean (Standard Deviation)
Unit of Measure: percentage
Baseline HbA1c 7.3  (1.2) 7.8  (2.0)
3rd month HbA1c 6.7  (1.1) 7.0  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin ( 002 Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-4.4 to 2.4
Parameter Dispersion
Type: Standard Deviation
Value: 1.07
Estimation Comments [Not Specified]
3.Primary Outcome
Title Comparison of Changes in Insulin Levels (HOMA IR,QUICKI) With Pioglitazone and Metformin
Hide Description

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)

Time Frame 3 months for each drug
Hide Outcome Measure Data
Hide Analysis Population Description
After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.
Arm/Group Title Pioglitazone (001 Group) Metformin ( 002 Group)
Hide Arm/Group Description:
Dose: Pioglitazone tablet 30 mg once daily for 3 months
Dose: Metformin tablet 850 mg once daily for 3 months
Overall Number of Participants Analyzed 48 32
Mean (Standard Deviation)
Unit of Measure: Score on a scale ( SI unit)
Baseline QUICKI 0.52  (0.08) 0.57  (0.12)
3rd month QUICKI 0.59  (0.12) 0.54  (0.09)
Baseline HOMA IR 5.1  (3.6) 3.7  (2.9)
3rd month HOMA IR 2.9  (1.9) 4.3  (3.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin ( 002 Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.40 to 0.27
Parameter Dispersion
Type: Standard Deviation
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin ( 002 Group)
Comments HOMA IR
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.004
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-14.12 to 15.52
Parameter Dispersion
Type: Standard Deviation
Value: 4.25
Estimation Comments [Not Specified]
4.Primary Outcome
Title Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin
Hide Description

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)

Time Frame 3 months for each drug
Hide Outcome Measure Data
Hide Analysis Population Description
After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.
Arm/Group Title Pioglitazone (001 Group) Metformin ( 002 Group)
Hide Arm/Group Description:
Dose: Pioglitazone tablet 30 mg once daily for 3 months
Dose: Metformin tablet 850 mg once daily for 3 months
Overall Number of Participants Analyzed 48 32
Mean (Standard Deviation)
Unit of Measure: percentage
Baseline HOMA percent beta cells function 118.9  (87.0) 109.3  (61.0)
3rd month HOMA percent beta cells function 132.3  (66.0) 116.0  (77.0)
Baseline HOMA percent sensitivity 51.1  (30.8) 76.2  (52.0)
3rd month HOMA percent sensitivity 69.3  (31.0) 67.2  (45.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin ( 002 Group)
Comments HOMA B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.808
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.79
Confidence Interval (2-Sided) 95%
-346.40 to 328.10
Parameter Dispersion
Type: Standard Deviation
Value: 84.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin ( 002 Group)
Comments HOMA S
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.025
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.53
Confidence Interval (2-Sided) 95%
-148.70 to 180
Parameter Dispersion
Type: Standard Deviation
Value: 54.00
Estimation Comments [Not Specified]
5.Primary Outcome
Title Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin
Hide Description 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.
Time Frame 3 months for each drug
Hide Outcome Measure Data
Hide Analysis Population Description
After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.
Arm/Group Title Pioglitazone (001 Group) Metformin ( 002 Group)
Hide Arm/Group Description:
Dose: Pioglitazone tablet 30 mg once daily for 3 months
Dose: Metformin tablet 850 mg once daily for 3 months
Overall Number of Participants Analyzed 48 32
Mean (Standard Deviation)
Unit of Measure: μU/ml
Baseline FSI 16.2  (8.7) 13.0  (8.8)
3rd month FSI 12.3  (7.5) 13.9  (7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin ( 002 Group)
Comments FSI
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.039
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.09
Confidence Interval (2-Sided) 95%
-27.04 to 26.52
Parameter Dispersion
Type: Standard Deviation
Value: 10.2
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Comparison of Changes in Lipid Profiles With Pioglitazone and Metformin
Hide Description

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)

Time Frame 3 months for each drug
Hide Outcome Measure Data
Hide Analysis Population Description
After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.
Arm/Group Title Pioglitazone (001 Group) Metformin (002 Group)
Hide Arm/Group Description:
Dose: Pioglitazone tablet 30 mg once daily for 3 months
Dose: Metformin tablet 850 mg once daily for 3 months
Overall Number of Participants Analyzed 48 32
Mean (Standard Deviation)
Unit of Measure: mg/dl
Baseline TC 182.0  (44) 193.0  (48.0)
3rd month TC 178  (42) 177.0  (38.0)
Baseline TG 183  (128) 166.0  (89.0)
3rd month TG 195  (165) 175.0  (108.0)
Baseline HDL 33  (10) 34.4  (9.0)
3rd month HDL 33.2  (8) 34.7  (7.0)
Baseline LDL 112.8  (105.5) 125.6  (47.0)
3rd month LDL 105.5  (47) 112.0  (34.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin (002 Group)
Comments TC
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.161
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.06
Confidence Interval 95%
-88.0 to 118
Parameter Dispersion
Type: Standard Deviation
Value: 39.47
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin (002 Group)
Comments TG
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.913
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.66
Confidence Interval (2-Sided) 95%
-397.0 to 976
Parameter Dispersion
Type: Standard Deviation
Value: 143.22
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin (002 Group)
Comments HDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.322
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-35.0 to 19.0
Parameter Dispersion
Type: Standard Deviation
Value: 9.59
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pioglitazone (001 Group), Metformin (002 Group)
Comments LDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.210
Comments Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.62
Confidence Interval (2-Sided) 95%
-113.8 to 76.2
Parameter Dispersion
Type: Standard Deviation
Value: 32.05
Estimation Comments [Not Specified]
Time Frame 3 months for pioglitazone treatment and next 3 months for metformin treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pioglitazone (001 Group) Metformin (002 Group)
Hide Arm/Group Description

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.

All-Cause Mortality
Pioglitazone (001 Group) Metformin (002 Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pioglitazone (001 Group) Metformin (002 Group)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/77 (0.00%)      2/70 (2.86%)    
Renal and urinary disorders     
Creatinine increase  2 [1]  0/77 (0.00%)  0 1/70 (1.43%)  1
Vascular disorders     
Hypertension  1 [2]  0/77 (0.00%)  0 1/70 (1.43%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, Systemic Data Review
2
Term from vocabulary, Data Observation
[1]
Patient's data review had shown the increase level of creatinine and was withdrawn from the trial in the 3rd month and referred to the hospital physician as it was assumed that its health was at risk.
[2]
Systemic review of the data and patient's complain had shown that the patient's health was at risk. The patient was withdrawn in the 3rd month from the trial and referred to the hospital physician for proper treatment.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pioglitazone (001 Group) Metformin (002 Group)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/77 (18.18%)      19/70 (27.14%)    
Gastrointestinal disorders     
Nausea * 1  1/77 (1.30%)  1 2/70 (2.86%)  2
Backpain * 1  1/77 (1.30%)  1 1/70 (1.43%)  1
Mild Diarrhoea * 1  0/77 (0.00%)  0 1/70 (1.43%)  1
Abdominal discomfort * 1  2/77 (2.60%)  2 5/70 (7.14%)  5
General disorders     
Weight gain * 1  4/77 (5.19%)  4 0/70 (0.00%)  0
Nervous system disorders     
Dizziness * 1  1/77 (1.30%)  1 2/70 (2.86%)  2
Headache * 1  1/77 (1.30%)  1 2/70 (2.86%)  2
Common Depression * 1  3/77 (3.90%)  3 6/70 (8.57%)  6
Vascular disorders     
Peripheral Edema * 1  1/77 (1.30%)  1 0/70 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Patients' complains
The sample size was relatively small for more detailed analysis, treatment period was also short and there was a possibility of confounding by the use of non-study medication.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Masuma Parvin
Organization: Ministry of Science and Technology, Government of the People's Republic of Bangladesh
Phone: 88 01819141258
Publications:
Trivedi B, Mazumdar JD, Bhatt, Hemavathi KG. Effect of Shilajit on blood glucose and lipid profile in alloxan-induced diabetic rats. Indian J Pharmacol 2004; 36: 373-376.
Michael J, Fowler MD. Microvascular and Macrovascular Complications of Diabetes. Clinical Diabetes 2008; 26 : 77-82.
Mahtab H, Khan AR, Latif ZA, Pathan F, Ahmed T. Guideline for care of Type 2 Diabetes Mellitus in Bangladesh. BIRDEM Clinical Research Group Publishing 2003.
Silink M. The diabetes epidemic: The case for a resolution on diabetes. Diabetic Endocrine Journal 2006; 34:3-4.
Krall LP. The wide world of diabetes. In: World book of diabetes in practice. Krall LP. (ed) v2 Amsterdam: Elsevier Science publishing; 1986.
Diabetes Statistics -Diabetes help. http://www.diabetes.org.uk/Professionals/ Publications-reports-and-resources/Reports-statistics-and-case-studies/Reports/ Diabetes-prevalance-2010
Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes research and clinical practice 2010; 8 7 (2 0 1 0 ) : 4 - 1 4.
Health Survey for England. http://www.heartstats.org/datapage.
National Service Framework for Diabetes: Standards http:// www. technology adoptioncentre.nhs.uk/assets/_files/documents/mar_10/nhs__1268044698_Diabetes_NSF.pdf
Diabetic Association of Bangladesh. Statistical Year Book. July 2009-June 2010; p 250. web version is available at www.dab-bd.org.
Gyas M. Interviewed by: Parvin M. 16 October 2011.
Kahn SE, Porte DJ. The pathophysiology of type II (noninsulindependent) diabetes mellitus: implications for treatment. In: Porte D Jr, Sherwin RS editor(s). Ellenberg & Rifkin's Diabetes Mellitus. 5th ed. Stamford, Conneticut (U.S.A.): Appleton & Lange, 1997.
DeFronzo RA. Pathogenesis of type 2 diabetes: metabolic and molecular implication for identifying diabetes genes. In: American Diabetes Association, eds (Annual Review Of Diabetes), AlexandriaVA: American Diabetes 1998; 1-93.
Kain K, Catto Aj. Trans-Cultural Medicine: Insulin Resistance Syndrome In South Asians. The British Journal of Diabetes & Vascular Disease 2002; 2: 398.
Zinnat R. Role of Insulin Defficiency and Insulin Resistance in the Pathogenesis of Type 2 Diabetes in Young Bangladesh Subjects. M.Phil thesis. Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders; 1999.
Alhossainy K. (kalhossainy@gmail.com). As per our database. Parvin M (acmasuma@gmail.com) 21 July 2011.
Thiazolidinedione http://en.wikipedia.org/wiki/Thiazolidinedione
Goodman & Gilmans'. The Pharmacological basis of Therapeutics. 10th ed. International Edition, McGraw Hill; 2001: p1701, 1704, 1706.
Lasker SP, McLachlan CS, Wang L, Ali SMK , Jelinek HF. Discovery, treatment and management of diabetes (Review Article). Journal of Diabetology Feb 2010; 1:1 http://www.journalofdiabetology.org/
Pickup JC, Willium G. The history of diabetes mellitus. In Textbook of diabetes. 3rd ed. Vol-1.Oxford London: Blackwell Science Limited; 2003.
Dabson M. Experiments and observations on the urine in diabetes. Med Obs Inq 1776; 5: 298-316.
Barnett DM, Krall LP. The History of diabetes. In Joslin's diabetes Mellitus, 14th ed. Boston MA. Lipincott William and Wilkins; 2005.
Stuart AR. Insulin and related medication. In Pharmacologic aspects of nursing. Paghiro, AM and Pagliaro, LA (eds). USA. The C.V. Mosby Company; 1988.
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Responsible Party: Dr. Masuma Parvin, University of Dhaka
ClinicalTrials.gov Identifier: NCT01589445     History of Changes
Other Study ID Numbers: BS-67/2008-09
BMRC/ERC/2007-2010/2024 ( Other Identifier: Bangladesh Medical Research Council )
First Submitted: April 29, 2012
First Posted: May 2, 2012
Results First Submitted: May 5, 2012
Results First Posted: February 27, 2014
Last Update Posted: February 28, 2014