A study to determine acute (after first dose) and chronic (after 28 days) effect oft he SGLT-2 inhibitor BI 10773 on pre and postprandial glucose homeostasis in patients with impaired glucose tolerance, type 2 diabetes mellitus and heathy subjects

• Conditions: patients with IGT, type 2 diabetes mellitus and healthy subjects; MedDRA version: 16.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 16.0Level: PTClassification code 10018429Term: Glucose tolerance impairedSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-018708-99-AT
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-23
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Inclusion criteria for patients (IGT and T2DM):
1a Male and female patients diagnosed with IGT according to the current ADA
guidelines as a two-hour glucose levels of 140 to 199 mg/dl (7.8 mmol/l to 11.1
mmol/l) on the 75-g oral glucose tolerance test, with an OGTT performed at the time
of the screening visit (Visit 1), or
1b Male and female patients diagnosed with type 2 diabetes mellitus prior to informed consent, on diet and exercise regimen who are drug-naive, defined as absence of any antihyperglycemic therapy for 12 weeks prior to the planned Day 1 of the trial, or,
1c Male and female patients diagnosed with type 2 diabetes mellitus prior to informed consent, who are pre-treated with metformin (only immediate release formulations permitted) background therapy, on a stable dose of metformin of at least 1500 mg per day, unchanged for at least 12 weeks prior to the planned Day 1 in the trial.
2 HbA1c at Visit 1 (screening):
a. For patients diagnosed of IGT: HbA1c < 6.5%
b. For patients diagnosed of T2DM: HbA1c = 6.5 % and = 10.5 %3 Age = 18 at Visit 1.
4 BMI = 20 and = 40 Kg/m2 (Body Mass Index) at Visit 1.
5 For patients who are under current antihypertensive treatment, this must be stable
(with no changes in dosage) within 4 weeks prior to the planned Day 1 (Visit 4) in the trial.
6 Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.

Inclusion criteria for healthy subjects:
1 Males or females matching the below mentioned criteria and otherwise healthy according to the investigator’s assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR) and clinical laboratory tests.
2 HbA1c at Visit 1 (screening): HbA1c < 6.5%
3 Confirmed normal glucose tolerance (NGT) by OGTT
4 Age = 45 and = 55 at Visit 1.
5 BMI = 30 and = 40 Kg/m2 (Body Mass Index) at Visit 1.
6 Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Acute coronary syndrome (non-STEMI, STEMI, unstable AP), stroke or TIA within 6 months prior to informed consent.
2. 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 (not on the same day).
3. Any other antidiabetic drug within 12 weeks prior to starting the open-label active
treatment (Visit 4) except those defined as background via inclusion criterion 1c.
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 during screening and/or run-in phase.
5. Impaired renal function, defined as eGFR < 60 ml/min (moderate and severe renal
impairment) as determined during screening and/or run-in phase.
6. Medical history of insufficient bladder emptying (i.e. neurogenic bladder disorders).
7. Patients with Hb values outside of normal reference ranges measured at central laboratory during screening and/or run-in phase.
8. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
9. Medical history of cancer (except for basal cell carcinoma) and/or treatment for
cancer within the last 5 years.
10. For patients on metformin background therapy, the investigator must check for
potential exclusion criteria according to local metformin label.
11. Treatment with anti-obesity drugs 3 months prior to
informed consent or any other treatment at the time of screening (i.e. surgery,
aggressive diet regimen, etc.) leading to unstable body weight.
12. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other
uncontrolled endocrine disorder except T2DM. However, the use of inhaled steroids
(e.g., for asthma, COPD) is not an exclusion as these do not cause systemic steroid
action.
13. Alcohol or drug abuse (according to investigators judgment) within the 3 months prior to informed consent that would interfere with trial participation or any ongoing
condition leading to a decreased compliance to study procedures or study drug intake.
14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial.
15. Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:
• Are nursing or pregnant or
• Are of child-bearing potential and are not practicing an acceptable method of
birth control, or do not plan to continue using this method throughout the
study and do not agree to submit to periodic pregnancy testing during
participation in the trial. Acceptable methods of birth control include tubal
ligation, transdermal patch, intra uterine devices/systems (IUD/IUSs), oral,
implantable or injectable contraceptives, sexual abstinence (if acceptable by
local authorities), double barrier method and vasectomised partner.
16. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified