Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: 1. Test 1: Fixed dose combination of Dapagliflozin and Sitagliptin Phosphate tablets
2. Test 2: Fixed dose combination of Dapagliflozin and Sitagliptin Phosphate.
3. Matching placebo:
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
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 Metformin IR (1500-2000 mg) as monotherapy for at least 08 weeks prior to screening 4)Patients with HbA1c greater than equal to 8 % and less than equal to 11 % at screening 5)Patients with BMI less than equal to 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
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 Fasting Blood Glucose (FBG) greater than equal to 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. sulphonamide) or to any of its excipients 4.Patients with administration of any therapy for diabetes, other than Metformin during the 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 greater than equal to 10 mg (betametasone greater than equal to 1.2 mg, dexamethasone greater than equal to 1.5 mg, hydrocortisone greater than equal to 40 mg) per day within 30 days prior to randomization; topical, nasal or inhaled corticosteroids are allowed 8.Patients with history of HIV and/or HBV and/ or HCV 9.Patients having significant renal (eGFR below 45 mL/min/1.73 m2) or hepatic impairment (AST and ALT greater than 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, surgery) which require insulin therapy at the time of screening or during the study period. Short term use i.e. ââ?°Â¤ 7 days will be allowed. 13.History of bariatric surgery (i.e., any surgery to treat obesity; for example, 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 having history or currently suffering with severe and disabling arthralgia 16.Patients who are lactose intolerant 17.Patients suffering from severe urinary tract infections (e.g. urosepsis, pyelonephritis), necrotizing fasciitis of the Perineum (Fournierââ?¬•s Gangrene), intravascular volume contraction and/ or female genital mycotic infections prior to 6 months from screening. 18.Patients having history or currently suffering with bullous pemphigoid requiring hospitalization 19.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 20.Patients with history of Unstable angina prior to 3 months from screening 21.Patients with history of Sustained and clinically relevant ventricular arrhythmia 22.Any of the following ECG abnormalities: -Second or third degree AV block without a pacemaker -Long QT syndrome or QTc greater than 500ms 23.Patients having history or currently suffering with serious allergic and hypersensitivity reactions such as anaphylaxis, angioedema and exfoliative skin conditions including Stev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c (Glycosylated haemoglobin)Timepoint: Baseline to end of week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in HbA1c (Glycosylated haemoglobin) 2.Mean change in Postprandial Blood Glucose (PPBG) 3.Mean change in Fasting Blood Glucose (FBG) 4.Proportion of Participants Achieving HbA1c less than 7.0% 5.Mean change in bodyweight 6.Number of patients requiring rescue medications 7.Safety assessment includes Treatment Emergent Adverse Events (TEAEs) reported during the study 8.Number of patients requiring hypoglycemia managementTimepoint: 1.Baseline to end of week 12 2.Baseline to end of week 12 and week 16 3.Baseline to end of week 12 and week 16 4.Week 12 and Week 16 5.Baseline to end of week 16 6.Baseline to end of study 7.Baseline to end of study 8.Baseline to end of study | — |
Countries
India
Contacts
Public ContactRajesh Gaikwad
Sun Pharma Laboratories Limited
Outcome results
None listed