NL-OMON38357
Completed
Phase 3
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 with a 104-week extension period in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment - C-SCADE-7
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- diabetes
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 18
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •(see paragraph 3\.3\.2 of the protocol for the complete list)
- •1\. Diagnosis of type 2 diabetes mellitus prior to informed consent
- •2\. Male and female patients on diet and exercise regimen who are
- •pre\-treated with immediate release metformin unchanged for 12 weeks prior to
- •randomisation. Minimum dose for metformin: \> \<\= 1500 mg/day or maximum tolerated
- •dose (the investigator must have documented the reason why up\-titration to \>\<\= 1500
- •mg/day was not possible) or maximum dose according to local label.
- •3\. HbA1c of \*7\.0% and \* 10% at Visit 1
- •4\. Age \* 18yrs
- •5\. BMI \* 45 kg/m2 (Body Mass Index) at Visit 1
Exclusion Criteria
- •(see paragraph 3\.3\.3 of the protocol for the complete list)
- •1\. Uncontrolled hyperglycaemia with a glucose level \>240 mg/dL (\>13\.3 mmol/L) after an
- •overnight fast during placebo run\-in and confirmed by a second measurement after an
- •overnight fast using another device (not on the same day).
- •2\. Any other antidiabetic drug within 12 weeks prior to randomisation except immediate release metformin
- •3\. Acute coronary syndrome (non\-STEMI, STEMI, unstable AP) 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) as determined at Visit 1
- •5\. Impaired renal function, defined as eGFR\<60 ml/min (moderate to severe renal impairment using MDRD formula)
Outcomes
Primary Outcomes
Not specified
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