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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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