Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: Glycomet GP1 Forte: Metformin Hydrochloride 1000mg
+ Glimepiride 1 mg
Once a Day - Oral administration
Intervention2: Glycomet GP2 Forte: Metformin Hydrochloride 1000mg + Glimepiride
Sponsors
USV Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects aged between 18 â?? 65 years of either sex. 2.Subjects newly diagnosed with Type 2 Diabetes. 3.Subjects with uncontrolled Type 2 Diabetes currently on metformin monotherapy. Uncontrolled diabetes as: •FBS ( >= 126mg/dL and = 200 mg/dL) •HbA1c levels >= 7.5% and 4.Women of childbearing potential who agree to not to become pregnant and use an appropriate contraceptive method (hormonal, IUD, or diaphragm). 5.Subjects willing to sign the Informed Consent Form and comply with the study visit as per protocol and perform 5-point home blood glucose monitoring as per protocol. 6.Subjects willing to provide audiovisual recording of the consent process. 7.Agree to follow recommended diet plan and physical activity instructions throughout the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with type 1 diabetes or secondary forms of diabetes. 2.Patients requiring insulin for glycemic control and or History of Insulin usage during 3 months preceding enrollment. 3.A pregnant or lactating women. 4.A female subject intends to become pregnant during the expected study duration. 5.Fasting Blood Sugar ( 6.HbA1c levels = 10% at screening. 7.Subjects who are currently on a combination therapy with 2 or more oral anti-diabetic agents. 8.Subjects with history of diabetic ketoacidosis and vascular complications. 9.Clinically significant renal disease with serum creatinine > 1.5 ULN. 10.Clinically significant liver disease with ALT and AST values 2.5 times ULN. 11.Congestive heart failure requiring pharmacological treatment. 12.History of Unstable angina within the past six months. 13.Acute metabolic diabetes complications during the 3 months prior to enrollment in this study. 14.History of acute coronary syndrome within the past 6 months. 15.Subjects on anti-tuberculosis treatment. 16.Subjects on any other chronic ailment treatment such as HIV, hepatitis B, hepatitis C and chronic kidney failure. 17.History of allergy to any of the drugs / investigational products. 18.History of chronic alcoholism. 19.Planned surgical intervention during the expected study duration. 20.History of any surgical interventions during 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in HbA1c at week 12Timepoint: 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| The change is FBS/ PBS at week 12. The change in BMI from baseline to end of week 12. The number of participants with episodes of hypoglycemic events in each arm. The number of serious adverse events reported in the study.Timepoint: 90 | — |
Countries
India
Contacts
Public ContactDr S Venkataraman
Apollo Hospitals
Outcome results
None listed