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CTRI Number  CTRI/2015/03/005596 [Registered on: 02/03/2015] Trial Registered Retrospectively
Last Modified On: 27/02/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A comparative study of three different classes of drugs used I the treatment of diabetes mellitus. Classes are: sulphonylureas, thiazolidinediones and DPP-IV inhibitors. 
Scientific Title of Study   Efficacy and safety study of Sulphonylureas, Thiazolidinediones and DPP-IV inhibitors in patients with Type 2 Diabetes Mellitus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjog Narain Tewari 
Designation  Junior Resident 
Affiliation  JNMC, AMU, Aligarh 
Address  Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh
Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India 
Phone  9760434368  
Fax    
Email  sanjogtewari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MOHAMMAD NASIRUDDIN  
Designation  Associate Professor 
Affiliation  J. N. Medical College, A.M.U.  
Address  Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9412596898  
Fax    
Email  naseer_bettiah@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR MOHAMMAD NASIRUDDIN  
Designation  Associate Professor 
Affiliation  J. N. Medical College, A.M.U.  
Address  Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh

Barabanki
UTTAR PRADESH
202002
India 
Phone  9412596898  
Fax    
Email  naseer_bettiah@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh, U.P., India PIN- 202002 
 
Primary Sponsor  
Name  J N Medical College 
Address  A.M.U., ALIGARH, UP-202002  
Type of Sponsor  Government medical college 
 
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 Sanjog Narain Tewari  OPD and IPD of department of Medicine and department of Pharmacologyy  Jawaharlal Nehru Medical College Aligarh Muslim University
Aligarh
UTTAR PRADESH 
9760434368

sanjogtewari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group I  Patients on Glimepiride 1 mg OD plus Metformin 500mg for 24 weeks 
Intervention  Group II  Patients on Pioglitazone 7.5 mg OD plus Metformin 500 mg OD for 24 weeks  
Intervention  Group III  Patients on Sitagliptin 100 mg OD plus Metformin 500 mg OD for 24 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Newly detected type 2 DM patients.
• Poorly controlled diabetics on oral hypoglycaemic agents.
 
 
ExclusionCriteria 
Details  • Type 1 Diabetes Mellitus
• Diabetic Nephropathy
• Diabetic Ketoacidosis (DKA)
• Patients on insulin
• Congestive Heart Failure (CHF)
• Acute infection
• Psychotic patient
• Pregnancy
• HIV / HBsAg / Anti-HCV and immuno-compromised patient
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Haemogram
2. Glycosylated Hemoglobin HbA₁c
3. Plasma Glucose (PG)
Fasting PG
2 hours PPG
4. Lipid Profile ( TC, TG, HDL, LDL, VLDL )
5. Liver Function Test (LFT)
 
baseline, 6 weeks, 12 weeks, 18 weeks and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Electrocardiogram (ECG)
C-reactive protein (CRP)
 
As and when indicated 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/08/2013 
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="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Diabetes mellitus (DM) refers to a group of common metabolic disorders that share the phenotype of hyperglycemia. Several distinct types of DM exist and are caused by a complex interaction of genetics and environmental factors. Depending on the etiology of the DM, factors contributing to hyperglycemia include reduced insulin secretion, decreased glucose utilization, and increased glucose production.(1)

Pathophysiology of type 2 diabetes mellitus

Type 2 DM is characterized by impaired insulin secretion, insulin resistance, excessive hepatic glucose production, and abnormal fat metabolism. Obesity, particularly visceral or central (as evidenced by the hip-waist ratio), is very common in type 2 DM (2)

The pathophysiology of type 2 diabetes includes, impaired insulin secretion, impaired insulin action, insulin resistance (3) and impaired incretin effect on β-cell function and non-suppression of the action of α-cells, with rising blood glucose levels.

Most important biochemical perturbations in type 2 diabetes mellitus involves peripheral and hepatic insulin resistance, and impaired β-cell function. In type 2 diabetes, adipose tissue in general and visceral fat in particular, exhibits a decreased inhibition of lipolysis and increased lipoprotein lipase activity, both resulting in a heightened flux of fatty acids in the liver and other tissues.

The skeletal muscle glucose utilization is impaired to a greater degree than adipose tissue in type 2 diabetes (4). This leads to impaired post-prandial glycogen deposition in muscles. The cause of this resistance is a high free fatty (FFA) concentration in the myocytes.

The hepatic insulin resistance leads to enhanced gluconeogenesis and glucogenolysis leading to increased hepatic glucose production, a hallmark of uncontrolled diabetes.

In type 2 diabetics, rapid meal-related insulin secretion (approx. 30 mins post-meal) is attenuated. Also, there is impaired rapid oscillation of insulin without any glycemic stimulus. The β-cell mass appears to be slightly reduced at the time of diagnosis. However, the functional capacity is impaired out of proportion to its mass.

Other pathogenetic mechanism involves incretins – a group of hormones secreted by gastrointestinal tract. Two extremely well known members glucagon like peptide (GLP-1) and glucose dependent insulinotropic peptide (GIP). The former is secreted from L cells of ileum and latter from the K cells located in the proximal small intestine. These hormones account for the enhanced insulin secretory response upon ingestion of glucose orally, as compared to that obtained by intravenous glucose administration. This has been termed the incretin effect (5). In the type 2 diabetes, the incretin effect is blunted, which can be corrected by injecting GLP-1 or its longer acting analogue, like exenatide or liraglutide. GLP-1 is normally destroyed by a group of enzymes called dipeptyl peptidases, of which dipeptyl peptidase-IV (DPP-IV) is the predominant one. Compounds inhibiting DPP-IV inhibitors prolong the effect of endogenous GLP-1 and are being used therapeutically at present.

Thiazolidinediones regulate transcription of genes involved in lipid and glucose metabolism, and is expressed in all insulin sensitive tissues even in pancreatic beta cells but mainly in adipocytes. TZDs stimulates PPAR-gamma agonists, increases number of small, insulin sensitive adipocytes which enhances glucose uptake, improves glycemic status, improve insulin sensitivities and protect beta cells by lowering the demand on, glucotoxicity and lipotoxicity(6)

Sulphonylureas bind to a specific site on the β cell KATP channel complex (the sulfonylurea receptor, SUR) and inhibit its activity.

 

Anti-diabetic drugs to be used

1)    Agents stimulating insulin release (secretagogues)

(A)           Suphonylureas

 Glibenclamide, Glipizide, Gliclazide and Glimepirid

(B)            DPP-IV inhibitors

Sitagliptin, Vildagliptin and Saxagliptin

2)    Agents lowering insulin resistance (sensitisers)

(A)           Biguanides:  Metformin

(B)            Thiazolidinediones: Pioglitazone and Rosiglitazone

 
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