Efficacy and Safety of BI 10773 With Metformin in Patients With Type 2 Diabetes

A phase III randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to glimepiride administered orally during 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001212

Enrollment

1400

Registered

2010-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: BI 10773: 25 mg, once daily Control Intervention1: Glimeperide: 1-4 mg

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1)Diagnosis type 2 diabetes mellitus, 2) male and female on diet and exercise regimen, drug naive or pre-treated with metformin 12 weeks prior to randomisation, 3)HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1, 4) 18 years or more (Restricted to patients <= 65 years of age as per upper age limit imposed by the DCG(I) for patients recruited in India), 5) BMI equal or less than 45Kg/m2.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1)uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in, 2)any other antidiabetic drug within 12 weeks prior to randomisation except metformin, 3) myocardial infarction, stroke or transient ischemic attack within 12 weeks of informed consent, 4) indication liver disease, 5)moderate to severe renal impairment, 6)bariatric surgery within past 2 years, 7)medical history of cancer or treatment for cancer within last 5 years, 8)blood dyscrasias or any disorders causing haemolysis or unstable red blood cell, 9)contraindications hypersensitivity to concomitant drugs, 10) treatment with anti-obesity drugs

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c after 104 weeks of treatmentTimepoint: Baseline and 104 Weeks;Change from baseline in HbA1c after 52 weeks of treatmentTimepoint: Baseline and 52 Weeks	—

Secondary

Measure	Time frame
Incidence of Adverse eventsTimepoint: Baseline and 104 Weeks;Incidence of Adverse eventsTimepoint: Baseline and 52 Weeks;Occurrence of adverse events of protocol specific significant AEsTimepoint: 104 Weeks;Occurrence of adverse events of protocol specific significant AEsTimepoint: 52 weeks;Occurrence of Cardiovascular events (Clinical Event Committee adjudication results)Timepoint: 104 weeks;Occurrence of Cardiovascular events (Clinical Event Committee adjudication results)Timepoint: 52 Weeks;Occurrence of Hypoglycaemic eventsTimepoint: 104 Weeks;Occurrence of Hypoglycaemic eventsTimepoint: 52 weeks;The change in blood pressure (SBP and DBP)Timepoint: Baseline and 104 weeks;The change in blood pressure (SBP and DBP)Timepoint: Baseline and 52 Weeks;The change in body weightTimepoint: Baseline and 104 Weeks;The change in body weightTimepoint: Baseline and 52 Weeks;The occurrence of confirmed symptomatic hypoglycaemic eventsTimepoint: Baseline and 104 Weeks;The occurrence of confirmed symptomatic hypoglycaemic eventsTimepoint: Baseline and 52 Weeks	—

Measure

Time frame

Incidence of Adverse eventsTimepoint: Baseline and 104 Weeks;Incidence of Adverse eventsTimepoint: Baseline and 52 Weeks;Occurrence of adverse events of protocol specific significant AEsTimepoint: 104 Weeks;Occurrence of adverse events of protocol specific significant AEsTimepoint: 52 weeks;Occurrence of Cardiovascular events (Clinical Event Committee adjudication results)Timepoint: 104 weeks;Occurrence of Cardiovascular events (Clinical Event Committee adjudication results)Timepoint: 52 Weeks;Occurrence of Hypoglycaemic eventsTimepoint: 104 Weeks;Occurrence of Hypoglycaemic eventsTimepoint: 52 weeks;The change in blood pressure (SBP and DBP)Timepoint: Baseline and 104 weeks;The change in blood pressure (SBP and DBP)Timepoint: Baseline and 52 Weeks;The change in body weightTimepoint: Baseline and 104 Weeks;The change in body weightTimepoint: Baseline and 52 Weeks;The occurrence of confirmed symptomatic hypoglycaemic eventsTimepoint: Baseline and 104 Weeks;The occurrence of confirmed symptomatic hypoglycaemic eventsTimepoint: Baseline and 52 Weeks

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Countries

India, Indonesia, Thailand

Contacts

Public ContactDr. Partha Gokhale

sandeep.nair@boehringer-ingelheim.com02226456477

Outcome results