Type 2 Diabetes-mellitus MedDRA version: 8.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
Product Code: RO4389620
Pharmaceutical Form: Capsule, soft
Current Sponsor code: RO4389620
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Product Code: RO4389
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria at Screening: 1. Age 18 to 75 years at the time of the screening examination 2. Willingness and ability to give written informed consent and to comply with the requirements of the study. Legally effective written informed consent must be obtained prior to completing any study procedures or discontinuing any medications in order to qualify for study enrollment. • Patients who cannot follow self monitoring of blood glucose and study requirements independently from another person cannot be included. 3. Type 2 diabetes mellitus treated with one oral antihyperglycemic agent, administered according to labeling for at least 3 months prior to screening 4. HbA1c = 7.0 % and = 10.0 % at screening 5. BMI = 45 kg/m2 at screening 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria at screening: 1. Type 1 diabetes mellitus 2. Fasting serum C-peptide 2.5 x ULN) at screening 8. Serum creatinine = 2.0 mg/dl (= 177 µmol/L) at screening 9. Blood pressure (SBP>150 mm Hg and/or DBP>90 mm Hg) without treatment or with stable treatment for > 3 months, labile or uncontrolled hypertension 10. Myocardial infarction or stroke within 6 months prior to the screening examination 11. Proliferative diabetic retinopathy 12. Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the Investigator 13. Pregnancy or breast feeding 14. Female patients of childbearing potential who, with their partners refuse to use two forms of contraception (including 1 barrier method) from screening and for 1 month following the last study medication intake 15. Participation in an investigational drug study within 90 days (3 months) prior to screening 16. Serious illness, such as active cancer, major active infection, severe psychiatric disorders at the time of the screening examination 17. History or evidence of alcohol or drug abuse Exclusion Criteria at Baseline: 1. Treatment with insulin and/or any antihyperglycemic agent during washout period 2. FPG 2.5 x ULN) at Visit 3 7. Serum creatinine = 2.0 mg/dl (= 177 µmol/L) at Visit 3 8. Positive pregnancy test in women of child bearing potential 9. Blood pressure (SBP>150 and/or DBP>90) without treatment or with stable treatment for > 3 months, labile or uncontrolled hypertension at baseline 10. Diagnosis or evidence of any new clinically significant diseases that may preclude patient from participating in the study. Clinical significance will be assessed per investigator’s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the response to treatment in patients with type 2 diabetes mellitus treated with RO4389620 when administered at increasing doses up to 200 mg BID. Response to treatment is defined by the percentage of patients with FPG <100 mg/dl without episodes of severe hypoglycemia;Secondary Objective: • To assess efficacy of RO4389620 administered at increasing doses up to 200 mg BID • To evaluate the safety and tolerability of RO4389620 when administered at increasing doses up to 200 mg BID • To evaluate in an exploratory manner possible trends in demographic and biologic parameters and safety and tolerability in patients requiring doses of RO4389620 up to 200 mg BID ;Primary end point(s): The percentage of patients at each dose who achieved FPG<100 mg/dl and did not experience episodes of severe hypoglycemia for the duration of the study | — |
Countries
Estonia, Latvia
Outcome results
None listed