Study to Assess Efficacy and Safety of Combination drug of Dapagliflozin, Glimepiride and Metformin Hydrochloride Tablets having extended release compared to Combination of Metformin Hydrochloride having prolonged release and Glimepiride Tablets in patients with Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2022/03/041424
• Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 395

Inclusion Criteria

1) Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study at the time of screening

2) Patients with diagnosis of type 2 diabetes mellitus

3) Patients along with diet and exercise control, additionally on stable total daily dose of Glimepiride 1 mg and Metformin Sustained Release/Prolonged Release/Extended Release 1000 mg for at least 8 weeks prior to screening

4) Patients with HbA1c >=8.0% and <= 11% at screening

5) Patients with BMI <= 45.0 kg/m2 at screening

6) Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence)

[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age.]

Exclusion Criteria

1) Patients diagnosed with type 1 diabetes, diabetes insipidus, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing syndrome or acromegaly-associated diabetes)

2) Patients with FBG >= 270 mg/dL at screening (if required, measurement can be repeated and confirmed within 7 days)

3) Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes (e.g. sulfonamide) or to any of its excipients

4) Patients with administration of any therapy for diabetes, other than Metformin and glimepiride during 8 weeks prior to screening

5) Patients with history of taking any weight loss medications within 3 months prior to randomization

6) Patients planning to take any anti-diabetic drugs or weight loss drugs other than study drugs or rescue medication during the study

7) Treatment with glucocorticoids equivalent to oral prednisolone >= 10 mg (betamethasone >= 1.2 mg, dexamethasone >= 1.5 mg, hydrocortisone >= 40 mg) per day within 30 days prior to randomization; topical, nasal or inhaled corticosteroids are allowed

8) Patients with history of HIV, HBV, and HCV.

9) Patients having significant renal (eGFR below 45 mL/min/1.73 m2) or hepatic impairment (AST and ALT Ë? 3 x ULN).

10) Patients taking loop diuretics within one week prior to screening or planning to take during the study

11) Patients suffering with end-stage renal disease or on dialysis

12) Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period. Short term use i.e. <= 7 days will be allowed

13) History of bariatric surgery (i.e. any surgery to treat obesity; for e.g. gastric banding or procedures that involve bypassing or transposing sections of the small intestine). History of liposuction is allowed.

14) Patients having history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis, pancreatitis or hyperosmolar state (including coma)

15) Patients who are lactose intolerant

16) Patients suffering from severe urinary tract infections (e.g. urosepsis, pyelonephritis), necrotizing fasciitis of the Perineum (Fournierâ??s Gangrene), intravascular volume contraction and/ or female genital mycotic infections prior to 6 months from screening

17) Patients with history of myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, stroke or transient ischemic attack prior to 6 months from screening

18) Patients with history of unstable angina prior to 3 months from screening

19) Patients with history of sustained and clinically relevant ventricular arrhythmia

20) Any of the following ECG abnormalities:

Second or third degree AV block without a pacemaker, Long QT syndrome or QTc > 500 ms

21) Patients having history or currently suffering with serious allergic and hypersensitivity reactions such as anaphylaxis, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome and urticaria.

22) Patients with symptomatic diarrhoea or any other medical condition which the Investigators may judge to be a risk for dehydration and hypovolemia

23) Patients with known alcohol or other substance abuse within last one year as per DSM-5 criteria.

24) Patients with NYHA class III or IV <br/

Study & Design

• Study Type: Interventional
• Study Design: Not specified