A Phase 3 study to evaluate the Efficacy, Safety and Tolerability of fixed dose combination of Dapagliflozin 10 mg Gliclazide 60 mg SR tablet in Patients with Type 2 Diabetes Mellitus who are inadequately controlled on Metformin Monotherapy.

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus with hyperosmolarity,

• Registration Number: CTRI/2023/01/049286
• Lead Sponsor: Eris Life Sciences Limited

Brief Summary

This trial is a phase III, prospective, randomized, Open Label, comparative, parallel group, multicenter clinical study to evaluate the efficacy, safety and tolerability of FDC Dapagliflozin 10mg Gliclazide 60mg SR with concomitant administration of Reference Product Dapagliflozin 10mg in patients with type 2 diabetes mellitus inadequately controlled on Metformin monotherapy. After confirming the inclusion/exclusion criteria the subject will be randomized and provided with study medication at randomization visit. Subjects will be provided with diary at randomization visit, which need to be brought along with in each subsequent visit till the last visit. Follow up visits will be done on week 4/day 28(±2), week 8/day 56(±2), week 12/day 84 ,Week 16 (End of Treatment) visit  to assess efficacy, safety and tolerability.



Total number of subjects enrolled in the study are 244 each arm consist  122 subjects. 122 subjects will receive intervention and 122 subjects will receive reference.Treatment will be given to patients for 16 weeks and follow up after one week.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-02
• Study Completion: 2023-11-30
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

• 1.Willing to give written informed consent to participate 2.Both genders (Male and Female) Age: 18-65 years both inclusive 3.Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative urine pregnancy test.
• 4.BMI: <35.0 kg/m2 5.HbA1c: ≥8.0% to ≤10.0% 6.In Patients with Type 2 Diabetes Mellitus who are inadequately controlled on Metformin Monotherapy ≥1000 mg per day for at least 3 months and having inadequate glycemic control 7.Patients willing to comply with the protocol requirements.

Exclusion Criteria

• 1.History of unstable or rapidly progressing renal disease 2.History of Type 1 diabetes mellitus 3.Patients with FPG ≥270mg/dl at screening to be excluded 4.Macroalbuminuria; defined as albumin-creatinine ratio of >500mg/g.
• 5.Estimated GFR <60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation) 6.Current/chronic use of the following medication: thiazolidinedione (TZD), SU derivative, Glucagon like peptide 1 receptor agonist (GLP-1RA), (dipeptidyl peptidase 4 inhibitor) DPP-4I, SGLT-2 inhibitors, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs).
• Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study.
• 7.Volume depleted patients.
• Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
• 8.Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e., sports injury, headache, or back ache).
• However, no such drugs can be taken within a timeframe of 2 weeks prior to renal testing 9.Current urinary tract infection and active nephritis 10.Recent (<6 months) history of cardiovascular disease, including: 1 Acute coronary syndrome 2 Chronic heart failure (New York Heart Association grade II-IV) 3 Stroke or transient ischemic neurologic disorder 11.Complaints compatible with neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan) 12.Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN 13.(Unstable) thyroid disease; defined as free thyroxine (fT4) outside of laboratory reference values or change in treatment within 3 months prior to screening visit 14.History of or actual malignancy (except basal cell carcinoma) Active cancer personal history of cancer within 5 years.
• History of or actual severe mental disease (Have any other condition including drug or alcohol abuse or psychiatric disorder including dementia that precludes the participant from following and completing the protocol as per judgement of the investigator.) Substance abuse (alcohol: defined as >4 units/day) 15.Allergy to any of the agents used in the study 16.Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study.
• 17.Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
• 18.History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
• 19.Severe uncontrolled hypertension defined as SBP ≥150 mmHg and/or Diastolic Blood Pressure (DBP) ≥100 mmHg 20.Inability to understand the study protocol or give informed consent 21.If participated in any other clinical trial within 6 months before the current study or concurrently enrolled/scheduled to be enrolled in any other type of medical research during the current study period.
• 22.Undergone a surgical procedure within 4 weeks prior to signing informed consent form.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Adjusted Mean Change from Baseline in glycated Haemoglobin A1c	Baseline to Week 16.
(HbA1c) at Week 16.	Baseline to Week 16.

Secondary Outcome Measures

Name	Time	Method
1. Adjusted Mean Change from Baseline in Fasting Plasma Glucose (FPG) at Week 16.	2. Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (16 Weeks).

Trial Locations

Locations (11)

Acharya Vinoba Bhava Rural Hospital; 🇮🇳 Wardha, MAHARASHTRA, India

Akshay Hospital & Diabetic Speciality Centre; 🇮🇳 Pune, MAHARASHTRA, India

Government of Bengal Medical College & Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

GOVERNMRNT MEDICAL COLLEGE AND GOVERNMENT GENERAL HOSPITAL; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Mahatma Gandhi Medical College and Research Institute; 🇮🇳 Pondicherry, PONDICHERRY, India

Medipoint Hospital; 🇮🇳 Pune, MAHARASHTRA, India

NKP Salve Institute of Medical Sciences & Research Centre & Lata Mangeshkar Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Shatayu Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

SMS Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

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Acharya Vinoba Bhava Rural Hospital

🇮🇳Wardha, MAHARASHTRA, India

Dr Sunil Kumar

Principal investigator

9850393787

sunilkumarmed@gmail.com