| CTRI Number |
CTRI/2024/12/078217 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study of Lobeglitazone Versus Pioglitazone on Urine Albumin to Creatinine Ratio (UACR) In Normotensive and Hypertensive Type 2 Diabetes Mellitus Patients |
|
Scientific Title of Study
|
A Comparative Study of Lobeglitazone Versus Pioglitazone on Urinary Albumin to Creatinine Ratio (UACR) In Normotensive and Hypertensive Type 2 Diabetes Mellitus Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Minakshi S ghuge |
| Designation |
junior resident |
| Affiliation |
MGM medical college and hospital |
| Address |
Department of Pharmacology MGM Medical College N 6 Cidco
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
08975996801 |
| Fax |
|
| Email |
minakshi291289@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Bobde |
| Designation |
Associate Professor |
| Affiliation |
MGM medical college and hospital |
| Address |
Department of Pharmacology N 6 Cidco MGM medical college and hospital
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
09423781558 |
| Fax |
|
| Email |
jyobobde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Minakshi S ghuge |
| Designation |
junior resident |
| Affiliation |
MGM medical college and hospital |
| Address |
Department of Pharmacology N 6 Cidco MGM Medical College and Hospital
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
08975996801 |
| Fax |
|
| Email |
minakshi291289@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical college and Hospital N 6 Cidco Aurangabad 431003 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
MGM Medical College and Hospital |
| Address |
N-6 Cidco Aurangabad 431003 Maharashtra India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Minakshi Ghuge |
MGM medical college and hospital |
Department of Pharmacology MGM medical college and hospital N 6 Cidco
Aurangabad
MAHARASHTRA |
08975996801
minakshi291289@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lobeglitazone |
Tab Lobeglitazone 0.5 mg once daily for 6 months |
| Comparator Agent |
Pioglitazone |
Tab Pioglitazone 15 mg once daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) T2DM patients of either gender between age group 18 to 60 years.
2) HBA1c between 6.5 to 8.5.
3) T2DM patients taking other oral antidiabetic drugs excluding the study drugs Lobeglitazone and Pioglitazone.
4) T2DM normotensive patients.
5) T2DM hypertensive patients taking either ACE inhibitors or ARBs with BP controlled to less than 140/90 mmHg.
6) T2DM patients with UACR between 30 to 300 mg per grams.
|
|
| ExclusionCriteria |
| Details |
1) Type 1 Diabetes mellitus.
2) Other secondary forms of diabetes
3) Patients with HBA1c more than 8.5 (uncontrolled diabetes).
4) T2DM patients with uncontrolled hypertension (greater than 140/90mmHg).
5) T2DM patients using insulin.
6) T2DM patients using TZDs within 60 days prior to consent.
7) Known hypersensitivity to TZDs.
8) T2DM patients with overt albuminuria
9) H/O macular edema
10) Congestive cardiac failure
11) Ischemic stroke or cerebral haemorrhage.
12) Hepatic dysfunction
13) H/O fractures
14) Active infection and trauma
15) Unable or unwilling to provide written informed consent
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative assessment of the change in UACR from baseline between lobeglitazone and pioglitazone in both normotensive and hypertensive T2DM patients. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Lobeglitazone and Pioglitazone on UACR in normotensive T2DM patients. |
6 months |
| To evaluate effect of Lobeglitazone and Pioglitazone on UACR in hypertensive T2DM patients. |
6 months |
| To compare the effect of Lobeglitazone v/s Pioglitazone on UACR in normotensive and hypertensive T2DM patients |
6 months |
| To study and compare the effect of Lobeglitazone v/s Pioglitazone on Glycaemic parameters in both groups of T2DM patients |
6 months |
| To study and compare the safety of lobeglitazone v/s pioglitazone per se patient reported adverse drug reactions |
6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
High
blood glucose levels are responsible for causing kidney damage. Studies have
demonstrated that TZDs can lead to improvements in albuminuria levels in
individuals with T2DM. Unlike some other
medications, TZDs have shown to have a neutral impact on the progression of DKD
and do not necessitate dosage adjustments based on kidney function. Pioglitazone
has achieved remarkable improvements of diabetic albuminuria regardless of
baseline kidney function; it was also advantageous in terms of preserving
kidney function in uncontrolled T2D patients, as add-on therapy, compared to
basal insulin. Lobeglitazone is a novel TZD developed in Korea
that has been used in several countries to treat patients with T2DM.
However, to date, the efficacy of lobeglitazone for reducing albuminuria in
T2DM patients in Indian population has not been studied. Also the efficacy of
TZDs for reducing albuminuria in hypertensive patients has not been studied. RESEARCH
QUESTION
Is
there a significant difference in effectiveness of Lobeglitazone and Pioglitazone
in reducing urinary albumin to creatinine ratio (UACR) in normotensive and
hypertensive type 2 diabetic patients? Aim:
To
compare the effect of lobeglitazone versus pioglitazone on urine
albumin to creatinine ratio (UACR) in normotensive and hypertensive T2DM
patients.
|