| CTRI Number |
CTRI/2011/06/001846 [Registered on: 30/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
11/11/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate the efficacy, safety and tolerability of fixed dose combination [FDC] Voglibose 0.3mg + Metformin (SR ) 500mg in treatment of patients with Type II diabetes |
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Scientific Title of Study
|
An Prospective, Open label, Multicentric, Non-Comparative, study to evaluate the efficacy, safety and tolerability of fixed dose combination [FDC] Voglibose 0.3mg + Metformin (SR ) 500mg in treatment of patients with Type II diabetes |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PPG-Met - AHPL/09/10 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
DrManoj Naik |
| Designation |
Chief Manager |
| Affiliation |
Abbott Healthcare Private Limited |
| Address |
D-Mart Building
Goregaon Mulund Link Road
Mulund(W)
Mumbai
Mumbai
MAHARASHTRA
400080
India |
| Phone |
022-39536910 |
| Fax |
|
| Email |
manoj.naik@piramal.com |
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Details of Contact Person
Public Query
|
| Name |
MrManoj Prabhu |
| Designation |
Manager |
| Affiliation |
Abbott Healthcare Private Limited |
| Address |
D-Mart Building
Goregaon Mulund Link Road
Mulund(W)
Mumbai
Mumbai
MAHARASHTRA
400080
India |
| Phone |
022-39536910 |
| Fax |
|
| Email |
manoj.prabhu@piramal.com |
|
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Source of Monetary or Material Support
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| Abbott Healthcare Private Limited, Mumbai |
|
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Primary Sponsor
|
| Name |
Abbott Healthcare Private Limited |
| Address |
D-Mart Building
Goregaon Mulund Link Road
Mulubnd (W)
Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNikhil Bhagwat |
B.Y.L Nair Charitable Hospital and T.N.Medical College |
Dr.A.L.Nair Road
Mumbai- 400008
Mumbai
MAHARASHTRA |
09820238399
nairendo@gmail.com |
| DrGanapathi Bantwal |
St.Johns Medical College & Hospital |
Sarjapur Road
Bangalore- 560034
Bangalore
KARNATAKA |
080-26531104
mallyaganapathi@rediffmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Review Board, St.Johns Medical College & Hospital |
Approved |
| Institutional Ethics Committee, B.Y.L.Nair Hospital Charitable Hospital &T.N.medical College |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type-II Diabetes, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Voglibose 0.3mg + Metformin SR 500mg |
Then newly diagnosed type2 diabetes patients will be allocated treatment with fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg one tablet once a day. The patients with uncontrolled glycemia on monotherapy with Metformin 1000 mg will be treated with fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg one tablet twice a day.. [Maximum 3 tablets of fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg will be allowed]. total treatment. Dose titartin will be as per HbA1c criteria and patient will be consuming medications for 180 days. |
|
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.18 years of age, upper limit at the discretion of Investigator.
2.Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Appendix B) at least 6 months prior to screening
3.Newly diagnosed Type 2 diabetes mellitus patients
4.Patients with type 2 diabetes mellitus who had previously received at least 3 months of continuous treatment with oral therapy of Metformin 1000 mg alone and is inadequately controlled [HbA1c 8% and HbA1c 11 %] during screening visit
5.Patient with BMI between 20 – 35 Kg/m2
6.Patients whose baseline fasting plasma venous glucose (FPG) concentration ranging from 126mg/dl but 200mg/dl
7.Patients whose venous plasma glucose concentration is 200 mg/dl at 2hr postprandial (after a meal) but 300mg/dl
8.Patients with stable dietary and exercise pattern since three month and willing to follow the same for entire trial duration.
9.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol-specific procedures are performed.
|
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| ExclusionCriteria |
| Details |
1.Type-1 diabetes mellitus
2.Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
3.Cardiac status New York Heart Association (NYHA) III-IV
4.Uncontrolled Blood pressure [ 140 Systolic and 90 Diastolic]
5.Impaired renal function as shown by, but not limited to, serum creatinine ¡Ý 1.5 mg/dL for males, or ¡Ý 1.4 mg/dL for females
6.Clinically significant peripheral edema
7.Acute infection
8.Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis
9.Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range
10.Patients on steroids
11.Patient with anticipated need of surgery within study period.
12.Patient known to be suffering from any bleeding disorder.
13.Pregnancy or lactating women
14.Known hypersensitivity to any of the study drugs.
15.Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
16.Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
17.Diagnosis of dementia
18.Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
19.Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
20.Any disease or condition that in the opinion of the investigator may interfere with the completion of the study
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
-No. of patients achieving HbA1C 7%
-Percentage reduction of fasting plasma glucose (FPG) from baseline.
|
Baseline Day30 Day90 and Day180
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
-Percentage of subjects achieving an HbA1C decrease by 1%
-Percentage reduction of PPG from baseline.
-Change in lipid parameters from baseline to Day 180
-Global assessment for efficacy and tolerability by investigator and patients at day 180.
-The adverse effects of the study drug will be assessed by monitoring adverse events, vital signs, physical examination and clinically significant changes in laboratory parameters.
|
Baseline Day30 Day90 and Day 180 |
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Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/05/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
An Prospective, Open label, Multicentric, Non-Comparative study to evaluate the efficacy, safety and tolerability of fixed dose combination [FDC] Voglibose 0.3mg + Metformin (SR ) 500mg in treatment of patients with Type II diabetes.
The study will be conducted at two centres in India only. A total of 110 patients will be enrolled in the study.
Then newly diagnosed type2 diabetes patients will be allocated treatment with fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg one tablet once a day. The patients with uncontrolled glycemia on monotherapy with Metformin 1000 mg will be treated with fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg one tablet twice a day. [Maximum 3 tablets of fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg will be allowed] Patients who do not respond to maximum dose will be considered as treatment failures and will be excluded from the study and will be treated as per Investigators Discretion.
HbA1C , FPG and PPG will be assessed at Day 30 and Day 90 , depending upon the HbA1c criteria the dose of the drug will be titrated and patient will be followed up till 180 days to evaluate-
-No. of patients achieving HbA1C < 7%,
- Percentage reduction of fasting plasma glucose (FPG) from baseline.
- Percentage of subjects achieving an HbA1C decrease by >1%
- Percentage reduction of PPG from baseline.
- Global assessment for efficacy and tolerability by investigator and patients |