Study to Assess Efficacy and Safety of Combination of Dapagliflozin, Glimepiride and Metformin Hydrochloride Tablets in Comparison to Glimepiride and Metformin Hydrochloride as Separate Tablets in Patients With Diabetes Mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/06/043249
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 536
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
2 mg and Metformin 1000 mg to 2000 mg (both inclusive) for at least 8 weeks prior to screening
4) Patients with HbA1c >= 8.0% and <= 11% at screening and randomization
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
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) and randomization
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 screening
6) Patients planning to take any anti-diabetic drugs (other than study drugs or rescue medication) or
weight loss drugs 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 screening;
topical, nasal or inhaled corticosteroids are allowed
8) Patients with history of HIV, HBV, and HCV
9) Patients having significant renal impairment eGFR below 45 mL/min/1.73 m2 or end-stage renal
disease or on dialysis) or hepatic impairment (AST and ALT Ë? 3 x ULN) at screening.
10) Patients taking loop diuretics within one week prior to screening or planning to take during the
study.
11) Any condition (e.g. infection, trauma, and surgery) which requires insulin therapy at the time of
screening or during the study period. Short term use i.e. <= 7 days will be allowed.
12) History of bariatric surgery (i.e. any surgery to treat obesity; e.g. gastric banding or procedures that
involve bypassing or transposing sections of the small intestine). History of liposuction will be
allowed.
13) Patients having history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and
lactic acidosis, pancreatitis or hyperosmolar state (including coma)
14) Patients who are lactose intolerant
15) 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
16) 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
17) Patients with history of unstable angina prior to 3 months from screening
18) Patients with history of sustained and clinically relevant ventricular arrhythmia
19) Any of the following ECG abnormalities at screening: Second or third degree AV block without a pacemaker, Long QT syndrome or QTc greater than 500 ms,
20) 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
21) Patients with symptomatic diarrhoea or any other medical condition which the Investigators may
judge to be a risk for dehydration and hypovolemia
22) Patient
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1c from Baseline at the end of Week 16Timepoint: Baseline, at the end of Week 16
- Secondary Outcome Measures
Name Time Method Proportion of Participants Achieving HbA1c 7.0% at the end of Weeks 12, 16 and 28Timepoint: Weeks 12, 16 and 28;Safety assessment includes TEAEs reported during the studyTimepoint: till end of study;Mean change in bodyweight from Baseline at the end of Weeks 12, 16 and 28Timepoint: Baseline, at the end of Weeks 12 and 28;Mean change in FBG from Baseline at the end of Weeks 12, 16 and 28Timepoint: Baseline, at the end of Weeks 12 and 28;Mean change in HbA1c from Baseline at the end of Weeks 12 and 28Timepoint: Baseline, at the end of Weeks 12 and 28;Mean change in PPBG from Baseline at the end of Weeks 12, 16 and 28Timepoint: Baseline, at the end of Weeks 12 and 28;Number of patients requiring hypoglycemia management by Weeks 16 and 28Timepoint: Weeks 16 and 28;Number of patients requiring rescue medications by Weeks 16 and 28Timepoint: Weeks 16 and 28