| CTRI Number |
CTRI/2021/11/037753 [Registered on: 02/11/2021] Trial Registered Prospectively |
| Last Modified On: |
25/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the differential benefits of various anti diabetic agents among individuals with novel subtypes of diabetes |
|
Scientific Title of Study
|
A 24 week randomized controlled trial assessing the effect of Glimepiride/ Metformin/ Vildagliptin/ Dapagliflozin on glycemic control in novel subtypes - Trial phase IV. |
| Trial Acronym |
CLUSTER |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
President |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department off Diabetology and Clinical Trials
4, Conran Smith Road Gopalapuram
Chennai
Tamil Nadu
Chennai TAMIL NADU 600086 India |
| Phone |
044-43968888 |
| Fax |
044-28350935 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
President |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department off Diabetology and Clinical Trials
4, Conran Smith Road Gopalapuram
Chennai
Tamil Nadu
Chennai TAMIL NADU 600086 India |
| Phone |
044-43968888 |
| Fax |
044-28350935 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person Public Query
|
| Name |
Dr V Mohan |
| Designation |
President |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department off Diabetology and Clinical Trials
4, Conran Smith Road Gopalapuram
Chennai
Tamil Nadu
Chennai TAMIL NADU 600086 India |
| Phone |
044-43968888 |
| Fax |
044-28350935 |
| Email |
drmohans@diabetes.ind.in |
|
|
Source of Monetary or Material Support
|
| Abbott Diabetes care Inc,
Alameda, California |
|
|
Primary Sponsor
|
| Name |
USV Private Limited |
| Address |
Arvind Vithal Gandhi Chowk,
Mumbai - 400 088
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Poongothai |
Dr.Mohans Diabetes Specialities Centre Pvt Ltd |
Department of clinical trials
No: #4,
conran smith road, Gopalapuram, Chennai - 600086 Chennai TAMIL NADU |
9840134505 - poongothaisubramani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASSESSING THE EFFECT OF GLIMEPIRIDE / METFORMIN / VILDAGLIPTIN/ DAPAGLIFLOZIN ON GLYCEMIC CONTROL
IN NOVEL SUBTYPES -
|
In the SIDD (intervention arm) vildagliptin 50mg BD will be given for first 2 months. If the HbA1C is morethan 8.5%, then Glimepiride 1-2 mg BD will be added for next 2 months. If the HbA1C still morethan 8.5% then mixtard insulin will be added.
In the IROD (intervention arm) Dapogliflozin 5-10mg OD will be given for first 2 months. If the HbA1C is morethan 8.5%
Metformin 500-1000 mg BD will be added for next 2 months. If the HbA1C still morethan 8.5% then mixtard insulin will be added.
In the CIRDD (intervention arm) Metformin 500-1000mg BD + Vildagliptin 50mg BD will be given for first 2 months. If the HbA1C is morethan 8.5%, then
Dapogliflozin 5-10mg OD will be added for next 2 months. If the HbA1C still morethan 8.5% then mixtard insulin will be added.
Route of drug administration is oral for Oral Hypoglycemic agents and Subcutaneous for Insulin.
Duration of study is 6 months
|
| Comparator Agent |
Comparing different oral hypoglycemic agents in the novel subtypes- type 2 Diabetes |
In the control arm of all cluster subtypes Metformin will be the first drug of choice for first two months, if the HbA1C is morethan 8.5%, then Glimepride 1-2mg BD will be added for next 2 months. If the HbA1C still morethan 8.5% then Mixtard insulin will be added.
Route of Drug administration is Oral for all Oral Hypoglycemic agents and Subcutaneous for Insulin.
Duration of study is 6 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. New onset of Type 2 diabetes (within 2 years of diagnosis)
2. Drug naive
3. Body Mass Index (BMI) ≤ 40.0 kg/m2
4. HbA1c (Glycated Hemoglobin) ≥ 7.0%
|
|
| ExclusionCriteria |
| Details |
1. Type 1 Diabetes
2. Use of any oral hypoglycemic agents or Insulin in past
3. Patients with a serum creatinine concentration greater than 132.6 mmol/L or liver function impairment
4. Significant alcohol, drug, or medication abuse
5. Currently under psychiatric care or using antipsychotic or mood stabilizer medication or diagnosed to have dementia or bipolar disorder or schizophrenia
6. History of anemia or hemoglobinopathy and/ or hemoglobin < 10 g/dL for men , <9 g/dL for women
7. Pregnant or lactating women
8. Documented CVD event in past 12 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1c between assigned treatment and control groups |
From baseline to week 12 and 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in FPG and 2-hour PPG levels |
From baseline to 12 and 24 weeks |
| Change in CGM profile |
From baseline to week 24 |
| Change in BMI |
From baseline to 12 and 24 weeks |
| Change in HOMA - B |
From baseline to week 24 |
| Change in HOMA - IR |
From baseline to week 24 |
| Change in Lipid profile |
From baseline to week 24 |
|
|
Target Sample Size
|
Total Sample Size="576" Sample Size from India="576"
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)
|
03/11/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Type 2 diabetes (T2D) exhibits considerable heterogeneity in its pathophysiology and clinical presentation. Identifying distinct T2D subgroups, characterized by clustering of phenotypic traits, has the potential to identify subsets of patients at differential risk of complications, and who are likely to respond differentially to various anti-diabetic medications. In a recent study of the Scandinavian population,five distinct ‘clusters’ of individuals with diabetes with significantly diverse characteristics were identified, Anjana et al, (2020) identified four replicable clusters among the Asian population. The four identifies clusters are Severe Insulin Deficient Diabetes (SIDD), Insulin Resistant Obese Diabetes (IROD), Combined Insulin Resistance and Deficient Diabetes (CIRDD), and Mild Age-Related Diabetes (MARD). Classifying T2D patients into phenotypic clusters provides insights into the pathophysiological processes driving diabetes, and aid in appropriate treatment selection, risk prediction, and focusing attention on individuals with the highest risk of morbidity and mortality . Though metformin is the first line of drug for T2D, not all patients respond equally well to it, necessitating the addition of other classes of antidiabetic agents to achieve glycemic targets. The selection of appropriate medication as initial therapy has the potential to minimize this delay and hasten the achievement of treatment goals. We, therefore, aim to assess the glycemic response of individuals with new-onset diabetes to different classes of anti-diabetic medications. |