Study to evaluate Efficacy and Safety of Fixed Dose Combination of Sitagliptin Phosphate, Metformin Hydrochloride and Glimepiride Tablets as Compared to administration of both Metformin Hydrochloride Tablets and Glimepiride Tablets in Patients with Type 2 Diabetes Mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/11/038169
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 392
1. Patients of either sex, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
2. Patients with diagnosis of type 2 diabetes.
3. Patients, along with diet and exercise control, additionally on stable total daily dose of Glimepiride 4 mg & Metformin Hydrochloride >= 1500 mg for at least 10 weeks prior to screening
4. Patients with HbA1c >= 8% and <= 11 %
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 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 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. Postmenopausal 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].
1. Patients with FBG >= 270 mg/dL at screening
2. Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes (e.g. sulfonamide).
3. Patients taking anti-diabetic drugs other than study drug at the time of screening or planning to take during the study.
4. Patients with history of HIV, HBV, and HCV.
5. Patients diagnosed with type 1 diabetes. Monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing syndrome or acromegaly- associated diabetes)
6. Patients having significant renal (eGFR below 45 mL/min/1.73 m2) or hepatic impairment (aspartate AST] and ALT Ë? 3 x ULN).
7. Patients having history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis or hyperosmolar state (including coma) within the past 6 months.
8. Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period.
9. Any weight loss medications within 3 months prior to randomization
10. Patients with NYHA class III or IV
11. Patients with history of myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, stroke or transient ischemic attack within past 6 months
12. Patients with history of unstable angina within the past 3 months.
13. Patients with history of sustained and clinically relevant ventricular arrhythmia.
14. Patients having history or currently suffering with severe and disabling arthralgia
15.Patients having history or currently suffering with bullous pemphigoid requiring hospitalization and taking DPP-4 inhibitors
16. Patients with inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption.
17. Any of the following ECG abnormalities:
Second or third degree AV block without a pacemaker
Long QT syndrome or QTc > 500 ms
18. Patients with any clinically significant laboratory abnormalities/condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
19. Pre-planned surgery or medical procedure that would interfere with the conduct of the study
20. Patients with known alcohol or other substance abuse within last one year as per DSM-5 criteria.
21.Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator.
22. Pregnant, lactating women or women of childbearing age who are not willing to use an acceptable method of birth control during the study period.
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: At the end of Week 16
- Secondary Outcome Measures
Name Time Method 1. Mean Change in HbA1c from baseline at the end of Week 28 <br/ ><br>Timepoint: at the end of Week 28;Mean Change in FBG from baseline at the end of Weeks 12, 16, 24 and 28Timepoint: at the end of Weeks 12, 16, 24 and 28;Mean Change in Postprandial Blood Glucose (PPBG) from baseline at the end of Weeks 12, 16, 24 and 28Timepoint: at the end of Weeks 12, 16, 24 and 28;Number of patients requiring hypoglycemia managementTimepoint: till end of treatment;Number of patients requiring rescue medicationsTimepoint: Till End of treatment;Proportion of Participants Achieving HbA1c 7.0% at Weeks 12, 16 and 28Timepoint: at Weeks 12, 16 and 28;Safety assessment includes Treatment Emergent Adverse Events (TEAEs) assessment during the studyTimepoint: during the study