Dr. Girithara Gopalakrishnan.J
- MD, PG Dip. DC (Australia)
Qualifications
Awards And Membership
Teaching Experience
Special interests
|
S.NO |
YEAR |
PHASE |
PROTOCOL TITLE |
|
1 |
2008 |
Three |
Effects of Naturlose (Tagatose) on glycemic control and safety of naturlose over one year in subjects with type 2 diabetes under diet control and exercise. |
|
2 |
2008 |
Three |
A randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 1356 (5.0 mg, administered orally once daily) compared to glimepiride (1 to 4 mg once daily) over two years, in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy |
|
3 |
2008 |
Three |
A Randomised double blind , placebo and ative comparator controled parallel group study of the efficacy and safety of Rivoglitazone as montherapy treatment of Type 2 Diabetes Mellitus CS0011-A-U301 |
|
4 |
2010 |
Three |
BI1245.23 A Phase III randomised, double-blind, placebo-controlled, parallel group efficacy and safety study of BI 10773 (10 and 25 mg) administered orally, once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea |
|
5 |
2010 |
Three |
MB102073 - “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 trial to evaluate the safety and efficacy of Dapagliflozin in subjects with type 2 Diabetes with inadequately controlled hypertension on an Angiotension-Converting enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) |
|
6 |
2010 |
Three |
D1680C00008 A 24-Week National, Multi-centre, Randomized, Parallel-group, Doubleblind, Placebo-controlled, Phase IIIb study in India to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control with Diet and Exercise |
|
7 |
2010 |
Three |
“A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week Multicenter Study with a 26-Week Extension to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 (Canagliflozin) Compared with Placebo in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy” |
|
8 |
2011 |
Three |
MB102077 – “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapaglifozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension treated with an Angiotensin-Converting Enzyme Inhibitor(ACEI) or Angiotensin Receptor Blocker(ARB) and an Additional Antihypertensive Medication” |
|
9 |
2011 |
Four |
A 20 weeks randomised, multinational, open labelled, 2 armed, parallel group comparison of twice daily subject driven titration of biphasic insulin aspart (BIAsp) 30 versus twice daily investigator-driven titration of biphasic insulin aspart (BIAsp) 30 both in combination with metformin in subjects with type 2 diabetes inadequately controlled on basal insulin analogues |
|
10 |
2011 |
Three |
A Phase III randomised, double-blind, placebo-controlled, parallel group efficacy and safety study of BI 10773 (10 and 25 mg) administered orally, once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea |
|
11 |
2012 |
Three |
A phase III randomised, double blind parallel group study to evaluate the efficacy and safety of once daily oral administration of BI10773 25 mg/linagliptin 5 mg anf BI 10773 10 mg/linagliptin 5 mg fixed doe combination tablets compared with the individual components for 52 weeks in treat naive and metformin treated patients with type 2 diabetes with inssuficent glycaemic control. |
|
12 |
2013 |
Three |
A randomised, double blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administrated as oral fixed dose combination with empagliflozin 10 mg or 25 mg for 24 weeks in patients with type 2 diabetes mellitus and insufficent glycemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy. |
|
13 |
2013 |
Three |
A randomised double blind clinical trial to study the efficacy and safety of MK-0431D (FDC) of sitagliptin and simvastatin for the treatment of patient with type 2 diabetes mellitus with inadequate glycemic control on Metformin montherapy |
|
14 |
2013 |
Three |
A randomised double blind, placebo controlled Multicenter study to assess cardiovascular outcomes following treatment with MK-3102 in subjects with type 2 diabetes mellitus |
|
15 |
2013 |
Four |
B1851140 A phase 4 opne label single arm multicenter study to describe the safety of 13-valent pneumococcal conjugate vaccine in healthy adult more than 50 years of age in india |
|
16 |
2013 |
Four |
A post marketing survelliance study to assess the efficacy and safety of PIVASTA tablets in patients of type 2 diabetes mellitus and dyslipidemia. Protocol No: Cardiva/2013/001 |
|
17 |
2013 |
Four |
A multicenter, prospective, randomised, opne label IV clinical study to evaluate the safety of Saroglitazar (ZYH1) as compared to fenofibrate in patients with dyslipidemia. |
|
18 |
2014 |
Three |
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week Multicenter Study with a 26-Week Extension to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 (Canagliflozin) Compared with Placebo in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy” |
|
19 |
2014 |
Three |
Trial ID NN1218-4049, Efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult Subjects with type 2 diabetes |
|
20 |
2015 |
Three |
Trial ID: EX1250-4080, A trial comparing cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events. |
|
21 |
2015 |
Four |
A Comparative study to assess the effect of VIldagliptin versus Glimepiride on glucose variability in type 2 diabetic patients uncontrolled on metformin alone.” |
|
22 |
2015 |
Three |
A Randomized, Double blind Comparative, Prospective, Placebo-controlled, Parallel-Group, Multicentre Study to evaluate the safety and Efficacy of Teneligilptin in Patients with Type 2 Diabetes Mellitus Inadequately controlled with Diet and Exercise Alone” |
|
23 |
2016 |
Three |
DUALTM VIII – Durability A 104 week clinical trial comparing long term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine therapy in subjects with type 2 diabetes mellitus
|
|
24 |
2016 |
Four |
A Multi-centre prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of Tresiba (insulin degludec) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India. |
|
25 |
2017 |
Three |
NN5401-4266: A 38 week trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification. |
|
26 |
2017 |
Three |
Protocol GPL\CT\2016\009\III: A 24 week, randomised, double-blind, double dummy parallel group, multicentre, active controlled study to evaluate efficacy and safety of remogliflozin etabonate in subjects with type 2 diabetes mellitus. |
|
27 |
2017 |
Three |
D169AC00001, A Stuyd to Evaluate the effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in patients with Chronic Kidney Disease. |
|
28 |
2017 |
Four |
Protocol NN BIAsp-4343 “A Multi-centre Prospective, non-interventional study of ability and willingness to pay for BIAsp 30 in a real world population with type 2 diabetes mellitus” |
|
29 |
2017 |
Four |
A Non Interventional nationwide registry to identify indian phenotype characteristics in Diabetes patients in India (IP registry study) Protocol no: D1843R00282 |
|
30 |
2017 |
Four |
A Prospective observational study of a pan-India cohort of patients with type 2 diabetes mellitus for macrovascular and microvascular complications, glycemic control, and time to treatment adaptation over 3 years |
|
31 |
2019 |
Three |
Trial ID: EX9924-4473 Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes (SOUL) |
|
32 |
2021 |
PMS |
Trial ID: NN1218-4489, An Indian multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance study of Fiasp® to evaluate safety and effectiveness in patients with diabetes mellitus in routine clinical practice |
|
33 |
2021 |
FOUR |
A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients. |
|
34 |
2022 |
Three |
A Prospective, Multi-center, Randomized, Open-Label, Parallel-group, Active-controlled, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Insulin Glargine 100 IU/mL Injection of M.J. Biopharm Private Limited with Lantus® (Insulin Glargine Injection) 100 units/mL in the Treatment of Patients Diagnosed with Type 2 Diabetes Mellitus |
|
35 |
2022 |
Three |
A Prospective, Randomized, Open Label, Multi Centre, Parallel Arm, Comparative Study with blinded Assessment to test the Non-Inferiority of Liraglutide Bio similar with Victoza in patients with Type 2 Diabetes Mellitus |
COUNTRIES VISITED FOR RESEARCH PURPOSE AND CONFERENCE
|
COUNTRY |
NO OF VISITS |
|
USA |
NINE |
|
UNITED KINGDOM |
FOUR |
|
AMSTERDAM |
FOUR |
|
GERMANY |
TWICE |
|
SINGAPORE |
FOUR |
|
FRANCE |
TWICE |
|
DUBAI |
TWICE |
|
MALAYSIA |
THRICE |
|
CHINA |
ONCE |
|
INDONESIA |
THRICE |
|
AUSTRALIA |
TWICE |
|
BANGKOK |
FOUR |
|
HONG KONG |
ONCE |
|
CAIRO |
ONCE |