| CTRI Number |
CTRI/2022/05/042922 [Registered on: 30/05/2022] Trial Registered Prospectively |
| Last Modified On: |
27/05/2022 |
| 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
|
Study to Know the Use of Metformin ER, Glimepiride and Voglibose combination in Diabetes Mellitus |
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Scientific Title of Study
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A Phase IV, Prospective, Open Label, Multi-Center, Parallel, Three Arm, Comparative Clinical Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Metformin ER, Glimepiride and Voglibose tablets in Adult Patients with Type 2 Diabetes Mellitus |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| HCR/IV/DIAMETGV/10/2020 Version 2.0 Dated 04-03-2021 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| 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 |
Dr Sreenivasa Chary S |
| Designation |
General Manager |
| Affiliation |
Hetero Drugs Limited |
| Address |
Clinical Development and Medical Affairs,
2nd Floor, 7-2-A2,
Hetero Corporate,
Industrial Estates,
Sanath Nagar,
Hyderabad
TELANGANA
500018
India |
| Phone |
04023704923 |
| Fax |
|
| Email |
sreenivasa.chary@heterodrugs.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhadeep Sinha |
| Designation |
Sr. Vice President |
| Affiliation |
Hetero Drugs Limited |
| Address |
Clinical Development and Medical Affairs,
2nd Floor, 7-2-A2,
Hetero Corporate,
Industrial Estates,
Sanath Nagar,
Hyderabad
TELANGANA
500018
India |
| Phone |
040-23704923 |
| Fax |
040-23801902 |
| Email |
sd.sinha@heterodrugs.com |
|
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Source of Monetary or Material Support
|
| Hetero Labs Limited, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 500018, India.
Tel: 91-40-23704923/24/25,
Fax: 91-40-23801902 |
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Primary Sponsor
|
| Name |
Hetero Labs Limited |
| Address |
7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 500018, India.
Tel: 91-40-23704923/24/25,
Fax: 91-40-23801902 |
| 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Gopal Rao |
Government Medical College & Govt. General Hospital (Old RIMSGGH) |
Department of Medicine,
OPD No 13, 1st Floor Srikakulam – 532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH |
9440122790
drgopalraoa@gmail.com |
| Dr Deo Nidhi Mishra |
Nirmal Hospital |
Opp.MLB Medical College, Ground Floor Devalaya,Room No 1
Gate no.3,Jhansi (U.P)-284128
Jhansi
UTTAR PRADESH |
9415031689
vdrmishra.nirmal@gmail.com |
| Dr BalRam Sharma |
SMS Medical College& Hospital |
Department of Endocrinology
Room No-43 A, Forth Floor Dhanvantri
OPD Block Jaipur 302004
Jaipur
RAJASTHAN |
9660226666
drbalramendo@gmail.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee SMS Medical College and Attached Hospitals |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College & Govt. General Hospital |
Submittted/Under Review |
| Nirmal Hospital Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FDC of Metformin hydrochloride SR 500mg and Glimepiride 1mg or 2mg |
One tablet twice daily, orally before major meals for the duration of 24 weeks |
| Comparator Agent |
FDC of Metformin hydrochloride SR 500mg and Voglibose 0.2 or 0.3mg |
One tablet twice daily, orally before major meals for the duration of 24 weeks |
| Intervention |
FDC of Metformin hydrochloride SR 500mg, Glimepiride 1mg or 2mg and Voglibose 0.2mg |
One tablet twice daily, orally before major meals for the duration of 24 weeks |
|
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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.Adult male or female patients aged of 18-65 years and willing to give written, signed, and dated informed consent to participate in the study.
2.Patients who are on metformin ≥1500mg/day and <2550mg/day at the time of screening.
3.Fasting plasma glucose ≥126 mg/dL (7.0 mmol/L) and HbA1C of 8%–11% at screening and end of run-in period.
4.Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
5.Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range of the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
|
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| ExclusionCriteria |
| Details |
1.Patient with Type 1 diabetes mellitus or secondary diabetes.
2.Patients with known hypersensitivity to any of the components of the study drugs.
3.Patients with fasting plasma glucose ≥250 mg/dL or ≥13.9mmol/L or a history of severe hypoglycemia (blood sugar ≤50 mg/dL or ≤2.8mmol/L).
4.Patients received insulin within 8 weeks prior to screening or Patients requiring insulin therapy or already on insulin therapy.
5.Patients received treatment with a PPARγ agent (e.g., pioglitazone or rosiglitazone) or incretin mimetics (e.g., exenatide) within 12 weeks.
6.Patients receiving treatment with systemic corticosteroids.
7.Patients with a body mass index (BMI) < 20 kg/m2 or > 43 kg/m2.
8.Patients with renal disease or renal dysfunction (creatinine clearance i.e. eGFR <30 ml/min/1.73 m2).
9.Patients planned for intravascular contrast studies with iodinated materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials) during the study period.
10.Patients with history of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis.
11.Patients with active heart disease (including acute myocardial infarction, unstable angina within 6 months), moderate to severe congestive heart failure (NYHA class III or IV), percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attacks.
12.Patients with history of acute or chronic liver disease with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >2.5 times of upper limit of normal reference range or total bilirubin >1.5 times of upper limit of normal reference range during the screening period.
13.Patients with history of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe peripheral neuropathy, symptomatic orthostatic hypotension, urinary retention, foot ulcers, or gastric stasis.
14.Patients with clinically significant renal, hepatic, cerebrovascular disease, known pituitary or gastric dysfunction, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infection.
15.Patients with the current/past infections such as Hepatitis B/C, and/or patients with immune system disorders like HIV.
16.Required to take or continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
17.History of drug or alcohol abuse within the past 2 years.
18.Currently is participating in another investigational study or has participated in an investigational study within 90 days prior to randomization. |
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Change in the glycated hemoglobin (HbA1c) |
At Day 1 and At Week 24 |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Proportion of patients achieving an HbA1C 7% |
At Week 24 |
| Change in the postprandial plasma glucose (PPG) |
At Day 1 and At Week 24 |
| Change in the fasting plasma glucose (FPG) |
At Day 1 and At Week 24 |
| No of patients requiring rescue therapy |
Throughout the study period |
| Rate of hypoglycemic episodes (severe hypoglycemia, documented symptomatic hypoglycemia and asymptomatic hypoglycemia) |
Throughout the study period |
| Incidence treatment emergent clinical, laboratory adverse events (TEAEs) including hypoglycaemic episodes |
Throughout the study period |
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Target Sample Size
|
Total Sample Size="333"
Sample Size from India="333"
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
|
Phase 4 |
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Date of First Enrollment (India)
|
30/05/2022 |
| 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="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None Yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This study is an Open Label, Multi-Center, Parallel, Three Arm, Comparative Clinical Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Metformin ER, Glimepiride and Voglibose tablets in Adult Patients with Type 2 Diabetes Mellitus. Patients will be screened for study eligibility based on the inclusion and exclusion criteria.
Patients eligible for the study will be randomized to either FDC of Metformin hydrochloride ER 500mg + Glimepiride 1/2mg + Voglibose 0.2mg or FDC of Metformin hydrochloride ER 500mg + Voglibose 0.2/0.3mg or FDC Metformin hydrochloride ER 500mg+ Glimepiride 1/2mg based on the randomization schedule. All patients will receive study drug twice daily, orally before major meals for the duration of 24 weeks. All patients will be followed up for 24 weeks for efficacy and safety assessments. The study is expected to be completed in approximately 12 months after dosing of the first patient. |