CTRI/2015/06/005914
Other
Phase 3
A phase III, randomized, double-blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administered as oral fixed dose combination with empagliflozin 10 mg or 25 mg for 24 weeks, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy -
BoehringerIngelheim India Pvt Ltd0 sites690 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Sponsor
- BoehringerIngelheim India Pvt Ltd
- Enrollment
- 690
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diagnosis of type 2 diabetes mellitus prior to informed consent
- •2\. Male and female patients on diet and exercise regimen and who are pre\-treated with an
- •unchanged dose of immediate release metformin for at least 12 weeks prior to Visit 2\.
- •Minimum dose for metformin is defined as:
- •\>\=1500 mg/day of metformin or
- •maximum tolerated dose (the investigator must have documented the reason why uptitration
- •to e.g. \>\= 1500 mg/day was not possible) or
- •maximum dose according to the local label (the investigator must have documented
- •the local label requirements in the medical records)
- •3\. HbA1c \>\= 8\.0% (64 mmol/mol) and \<\= 10\.5% (91 mmol/mol) at Visit 1 for randomization into the 16 week treatment period.
Exclusion Criteria
- •1\. Uncontrolled hyperglycaemia with a glucose level 270 mg/dl (15\.0 mmol/L) after an overnight fast during the open label period (from Visit 2 to Visit 4\) and placebo add on
- •run\-in period (Visit 4 to Visit 5\) and confirmed by a second measurement (not on the
- •same day and done either at the central or local laboratory).
- •2\. Any other antidiabetic drug within 12 weeks prior to Visit 2 randomization (except metformin background therapy as defined via inclusion criterion 2\).
- •3\. Acute coronary syndrome (non\-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent
- •4\. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) based on Visit 1 and Visit 4 laboratory parameters.
- •5\. Impaired renal function, defined as eGFR 60 ml/min/1\.73 m2 (MDRD formula) as determined during screening (Visit 1\) or placebo add on run\-in (Visit 4\)
- •6\. Known hereditary galactose intolerance
- •7\. Known contraindications to metformin or linagliptin according to the local label (where
- •8\. Any previous (within the past two years) or planned bariatric surgery (or any other weight
Outcomes
Primary Outcomes
Not specified
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