Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: O Glimaday: Glimepiride (1mg/2mg/3mg) and Metformin 1000mg
orally once daily for one month
Control Intervention1: Glycomet GP: Glimepiride (1mg/2mg/3mg) and Metformin 500mg
orally once daily for one month
Sponsors
Wockhardt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult (>=18 years to 2. Newly diagnosed type 2 DM subjects or subjects who are uncontrolled on Metformin/Glimepiride monotherapy with HbA1c of >=7.5% to 3. In the opinion of investigator, the participant is considered appropriate to receive Glimepiride along with Metformin. 4. In the opinion of investigator, the participant is unlikely to require additional antidiabetic agents (oral or parenteral) during the study. 5. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 6. Signs and dates a written, informed consent form prior to the initiation of any study procedures.
Exclusion criteria
Exclusion criteria: 1. Abnormal clinical examination including manifestation of renal and hepatic impairment. 2. History of recurrent hypoglycaemic episodes or event of severe hypoglycaemia in past 3 months 3. Patient on current concomitant medications that may interfere with study assessment like but not limited to Corticosteroids, Thyroxine, Diuretics or alternative system of medicine e.g. Ayurvedic or Homeopathic 4. Has a history of lactic acidosis. 5. Has dehydration or gastrointestinal dysfunction such as diarrhoea or vomiting, which may cause dehydrated state. 6. Has any serious cardiac disease, any serious cerebrovascular disorder, or any serious pancreatic or hematological disease. 7. Has a condition requiring insulin for blood glucose control (eg, severe ketosis, diabetic coma, type 1 diabetes, severe infection, pre- or post-operative condition, or serious trauma). 8. Has any malignancy. 9. Has a history of hypersensitivity or allergies to sulphonylureas or biguanides. 10. Is a habitual drinker consuming more than 100 mL of alcohol on average daily. 11. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol dependence. 12. If female, the participant is pregnant or lactating; intending to become pregnant during study period or who is sexually active with a non-sterilized male partner not consenting to routinely use adequate contraception from signing of informed consent throughout the duration of the study 13. Is considered ineligible for the study for any other reason by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of GI intolerability within 4 weeks of therapyâ?? Abdominal pain, diarrhea, nausea, vomiting, dyspepsia, heart burn, retching, bloating, flatulence, indigestion.Timepoint: At day 7 and Day 30 post enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients withdrawing from study due to gastrointestinal intolerability within 7 days of initiation of therapy.Timepoint: At day 7 post enrollment;Other adverse drug reactions reported at visit 4.Timepoint: At day 30 post enrollment | — |
Countries
India
Contacts
Public ContactDr Khokan K Debnath
Wockhardt Ltd.
Outcome results
None listed