| CTRI Number |
CTRI/2011/06/001841 [Registered on: 29/06/2011] Trial Registered Prospectively |
| Last Modified On: |
17/10/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
This study is done to assess Effectiveness and Safety study of a three drug combination with a two drug combination for the treatment of type 2 diabetes mellitus in patients who have never received insulin.
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Scientific Title of Study
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A Randomized, Prospective, Parallel, Single Centre, Open label, Comparative, Effectiveness and Safety study of Fixed dose combination [FDC] of Triple Oral Therapy of Glimepiride 2mg + Metformin 500 mg SR + Pioglitazone 15mg Vs
Insulin 70/30 Mix Metformin 500mg SR treatment in insulin-naïve patients with type 2 diabetes inadequately controlled on dual, Glimepiride 1 / 2 mg + Metformin 500 mg therapy (HbA1c more than 8%) |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| SCARC/2011/02 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMahesh Padsalge |
| Designation |
(MD) medicine, consultant Physician |
| Affiliation |
|
| Address |
SHIVAM CLINIC AND RESEARCH CENTRE
No: 23, Ambika Shopping Centre,Sector- 8, Nerul ( west)
Mumbai
MAHARASHTRA
400706
India |
| Phone |
022-27719497 |
| Fax |
022-27719497 |
| Email |
drmaheshpadsalge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMahesh Padsalge |
| Designation |
|
| Affiliation |
|
| Address |
SHIVAM CLINIC AND RESEARCH CENTRE
No: 23, Ambika Shopping Centre,Sector- 8, Nerul ( west)
Mumbai
MAHARASHTRA
400706
India |
| Phone |
022-27719497 |
| Fax |
022-27719497 |
| Email |
drmaheshpadsalge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMahesh Padsalge |
| Designation |
|
| Affiliation |
|
| Address |
SHIVAM CLINIC AND RESEARCH CENTRE
No: 23, Ambika Shopping Centre,Sector- 8, Nerul ( west)
Mumbai
MAHARASHTRA
400706
India |
| Phone |
022-27719497 |
| Fax |
022-27719497 |
| Email |
drmaheshpadsalge@gmail.com |
|
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Source of Monetary or Material Support
|
| This is Investiagtor initiated study and funded by Abbott India Limited |
|
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Primary Sponsor
|
| Name |
Abbott India Limited |
| Address |
Abbott India Limited
3-4, Corporate Park
Sion-Trombay Road
Mumbai 400071
India |
| 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMahesh Padsalge |
Shivam clinic and Research centre |
No: 23, Ambika Shopping Centre,Sector- 8, Nerul ( west)-400706
Mumbai
MAHARASHTRA |
022-27719497
022-27719497
drmaheshpadsalge@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Alert EC- IEC independent ethics comittee |
Approved |
| Alert EC-IEC Independent Ethics Comittee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Treatment in insulin-naïve patients with type 2 diabetes , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Insulin 70/30 + Metformin |
The treatment period will be of 12 wks. The study period will be approximately 90 days (Screening 7 days + Treatment period 12 weeks). Two day window period shall be provided for each visit. |
| Intervention |
Triobimet 1 |
Glimepiride 1mg + Metformin 500 mg SR + Pioglitazone 15mg
Oral
The treatment period will be of 12 wks. The study period will be approximately 90 days (Screening 7 days + Treatment period 12 weeks). Two day window period shall be provided for each visit. |
| Intervention |
Triobimet 2 (Glimepiride 2mg + Metformin 500 mg SR + Pioglitazone 15mg )
oral
|
The treatment period will be of 12 wks. The study period will be approximately 90 days (Screening 7 days + Treatment period 12 weeks). Two day window period shall be provided for each visit. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subjects meeting all of the following criteria will be considered for enrollment into the study
-Subjects or their legally-acceptable representatives (LARs) must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
-18 years of age, upper limit at the discretion of Investigator.
-Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Appendix A) at least 6months prior to screening.
-HbA1C greater than 8%
-Insulin naive
-Patients who are either not receiving or are on a constant dose of lipid lowering agent/s since last three months.
-Patients with stable dietary and exercise pattern since three months and willing to follow the same for the entire trial duration.
(There is no upper limit to age)
|
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| ExclusionCriteria |
| Details |
-Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
Cardiac status New York Heart Association (NYHA) III-IV
Impaired renal function as shown by, but not limited to, serum creatinine more than or equal to 1.5 mg/dL for males, more than or equal to 1.4 mg/dL for females
Use of Oral hypoglycemic agent in the past 3 months
Acute infection
Clinically significant peripheral edema
Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis
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
History of hypoglycemia unawareness
Pregnancy or lactation
Known hypersensitivity to any Oral hypoglycemic agent.
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
Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
Diagnosis of dementia
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
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
Indications of Insulin in Type 2 Diabetes
At onset, if FBG is 250 mg/dl and/or ketonuria. In stressful situations (acute myocardial infarction, stroke, fulminant infections, trauma). During pregnancy. Perioperative state. Hepatic and renal decompensation. Diabetic coma Idiosyncrasies to oral anti-diabetic agents. Secondary failure to OHA. Diabetics on steroids
Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in HbA1c from baseline to Week 12 |
week 12 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
-Percentage of subjects achieving an HbA1C decrease by 1%
-Change from baseline to week 12 of FPG and PPG
-Global assessment for effect and tolerability by investigator and patients at day 84.
|
change in study status from baseline to week 12 |
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
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Publication Details
|
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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
|
- Protocol Title: This is a randomized, single centre, open lable study to assess the effectiveness and safety of FDC glimepiride 2mg+metformin500 mg+pioglitazone 15 mg VS Insulin 70/30 + Metformin 500 mg.
- This is IIS ( Investigator initiated study).
- Methodology:
- Screening: Patients would be evaluated for eligibility and baseline laboratory investigations shall be performed Randomization: The eligible patients shall be randomized into 2 arms (Arm A & B) Arm A: Patients shall receive FDC of either: 1> Glimipiride 1 mg + Metformin 500 SR + Pioglitazone 15 mg OD (Triobimet 1)OR 2> Glimipiride 2 mg + Metformin 500 SR + Pioglitazone 15 mg OD (Triobimet 2) (As per investigators decision)
- Arm B: Patients shall receive Insulin 70/30 + Metformin SR Therapy to be initiated with insulin 70/30 mix b.i.d. (starting dose, 0.75 units/kg). Two-thirds of the dose to be given before breakfast and the remainder before dinner. Dose adjustments of 10% of the current dose can be done at discretion of investigator, until the glycemic (FPG and postprandial glucose) targets are achieved. The patient shall continue to receive Metformin SR once a day in morning in addition to Insulin 70/30 mix In both the arms the dose of oral anti-diabetic agents shall be titrated as per the target HbA1c
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Duration of Treatment: The treatment period will be of 12 wks. The study period will be approximately 90 days (Screening 7 days + Treatment period 12 weeks)
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Duration of follow-up: Each patient shall be followed up for 3 months
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