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: Health Condition 1: E110- Type 2 diabetes mellitus with hyperosmolarity

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-11-30
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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 proto

Study & Design

• Study Type: Interventional
• Study Design: Not specified