| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 | | E.1.2 | Level | LLT | | E.1.2 | Classification code | 10045242 | | E.1.2 | Term | Type II diabetes mellitus | |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial | The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of three doses of BI 10773 compared to placebo given for 12 weeks in patients with T2DM with insufficient glycemic control.
In addition, there will be an open-label treatment arm with metformin for sensitivity measurement within this patient population. Pharmacokinetics of BI 10773 will also be assessed in this study.
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| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria | 1.Male and female patients with a diagnosis of type 2 diabetes mellitus, who are drug naïve (10 week oral antidiabetic drugs, 3 months glitazones, GLP-1 analogues, insulin, or never on a drug for diabetes prior to informed consent) or treated with one oral antidiabetic drug other than those described in the Exclusion Criteria. Antidiabetic therapy has to be unchanged for at least 10 weeks prior to screening.
2.Glycosylated hemoglobin A1 (HbA1c) at Visit 1A (Screening)
a.for patients treated with one oral antidiabetic drug: HbA1c ≥6.5 to ≤9.0%;
b.for patients who are drug naïve: HbA1c ≥7.0 to ≤10.0%
3.Glycosylated hemoglobin A1 (HbA1c) ≥7.0 to ≤10.0% at Visit 2 (Start of Run-in)
4.Age ≥18 and ≤80 years at Visit 1A (Screening)
5.Body Mass Index (BMI) ≤40 kg/m2
6.Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
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| E.4 | Principal exclusion criteria | 1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent;
2. Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), or alkaline phosphatase above 3 times the upper limit of normal (ULN) as determined at screening;
3. Renal insufficiency or impaired renal function defined by creatinine clearance <50 mL/min (calculated) or serum creatinine levels men ≥ 1.5 mg/dL ; women ≥1.4 mg/dL as determined at screening;
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurological disorders (including cerebrovascular disease and polyneuropathy) that may interfere with participation in the trial;
5. Chronic or clinically relevant acute infections (e.g. human immunodeficiency virus, hepatitis);
6. Current or chronic urogenital tract infection determined by medical history
7. History of clinically relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients);
8. Treatment with any of the following anti-diabetic treatments within 3 months prior to informed consent:
a.glitazones (e. g. rosiglitazone, pioglitazone),
b.glucagon-like peptide (GLP-1) analogues
c.insulin
9. Treatment with anti-obesity drugs (e. g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent;
10. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent;
11. Alcohol abuse within the last 3 months that would interfere with trial participation or drug abuse;
12. Treatment with an investigational drug within 2 months prior to informed consent
13. Known intolerance to metformin
14. Dehydration by clinical judgment of the investigator
15. Unstable or acute congestive heart failure
16. Acute or chronic metabolic acidosis (present condition in patient history)
17. Hereditary galactose intolerance
18. Women of child-bearing potential who:
a.are nursing or pregnant, or
b.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 periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy. No exception will be made.
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| E.5 End points |
| E.5.1 | Primary end point(s) | | The primary endpoint in this study is the change of HbA1c from baseline after 12 weeks of treatment. | |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description | | in addition an open label metformin arm is used | |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 | The trial involves single site in the Member State concerned | No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 75 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
