A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of the SGLT-2 Inhibitor Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus.
In patients with poorly controlled diabetes, up-regulation of distinct glucose transporters including SLGT2 results in increased renal tubular glucose reabsorption. An orally available, potent and selective SGLT2 inhibitor such as BI 10773 lowers both the saturation threshold and the transport maximum of glucose levels with low risk of hypoglycaemia, and negative energy balance with potential weight reduction.
The effect of BI 10773-mediated urinary glucose and calory loss on endogenous glucose production (EGP) is unknown. Under normal circumstances, ingestion of a mixed meal leads to a protracted suppression of endogenous glucose production. Such effect is known to be impaired in patients with diabetes, whose postprandial EGP is inappropriately elevated and contributes to the hyperglycaemia.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Phase II Study to Determine Acute (After the First Dose Administration) and Chronic (After 28 Days of Treatment) Effects of the Sodium-glucose Co-transporter-2 (SGLT-2) Inhibitor BI 10773 (25 mg Once Daily) on Pre and Postprandial Glucose Homeostasis in Patients With IGT and Type 2 Diabetes Mellitus|
- The primary efficacy endpoint in this study is the change in glucose metabolism (fasting and postprandial glucose) in patients with Impaired Glucose Tolerance (IGT), and patients with Type 2 Diabetes Mellitus (T2DM) on diet or metformin. [ Time Frame: After 1 and 28 days of treatment ] [ Designated as safety issue: No ]
- The secondary efficacy endpoint is the change in rate of endogenous glucose production. [ Time Frame: After 1 and 28 days of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: BI 10773 Arm
BI 10773 high dose once daily
Drug: BI 10773
BI 10773 tablets once daily high dose
|Contact: Boehringer Ingelheim Call Centeremail@example.com|
|1245.39.43001 Boehringer Ingelheim Investigational Site||Recruiting|
|1245.39.49002 Boehringer Ingelheim Investigational Site||Recruiting|
|1245.39.39001 Boehringer Ingelheim Investigational Site||Recruiting|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim Pharmaceuticals|