A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.

A MULTICENTER, DOUBLE-BLIND, RANDOM ASSIGNED, PLACEBO-CONTROLLED, DOSAGE ADJUSTMENT STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACODYNAMIC PROFILES OF DIFFERENT DOSES OF RO5073031 IN PATIENTS WITH DIABETES MELLITUS TYPE 2 TREATED WITH A STABLE METFORMIN DOSE (BC20728 )

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-021-07

Enrollment

Registered

2007-05-16

Start date

2007-06-26

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

GROUP 1 Type of group

This group will be treated with RO5073031 Placebo, in vials of 200 uL in 0.2 mL, SC, every week for 8 weeks. In addition to continuing with your usual and stable dose of Metformin. Group name:GROUP 4 Type of group

This group will be treated with RO5073031, in vials of 200 uL in 0.2 mL, at a dose of 20 mg SC, every week for 4 weeks. Subsequently, the dose of RO5073031 will be increased to 40 mg, in vials of 400 uL in 0.4 mL, SC, every week for 4 more weeks, until completing the 8 weeks of treatment. In addition to continuing with your usual and stable dose of Metformin.

Eligibility

Inclusion criteria

Inclusion criteria: 1. That they can and wish to grant written informed consent and comply with the requirements of the study protocol. 2. Patients with type 2 diabetes mellitus treated with stable metformin monotherapy for at least 3 months before screening. 3. Age from 18 to 75 years at the time of selection. 4. HbA1c ≥ 7.0% and ≤ 9.5% in the selection. 5. Fasting plasma glucose (FPG)> 126 mg / dL and ≤240 mg / dL. 6. BMI> 25 kg / m2 and ≤ 45 kg / m2 in the selection. 7. Stable weight ± 10% for at least 3 months before selection. 8. If receiving ACE inhibitors, angiotensin II agonists, beta blockers, thiazide-based diuretics, thyroid hormones, and / or lipid-lowering medications, doses should have been stable for at least 6 weeks before screening. 9. Men, postmenopausal women or surgically sterilized women.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to R05073031 or to any of the components of the formulation. 2. Patients with type 1 diabetes mellitus. 3. Clinically important GI disease. 4. Uncontrolled hypertension. 5. Myocardial infarction or cerebrovascular accident within 6 months prior to selection. 6. Known proliferative diabetic retinopathy. 7. Hemoglobinopathy or chronic anemias known. 8. Evidence of serious concomitant disease. 9. Any new condition diagnosed in the selection that requires treatment for more than 10 days or chronic treatments that can not be stabilized during the selection period. 10. Known contraindications to metformin. 11. History of ketoacidosis or lactic acidosis. 12. Any previous exposure to GLP-1, GLP-1 analogs or exenatide. 13. Treatment with any antihyperglycemic agent other than monotherapy with metformin within 3 months prior to selection. 14. Systemic use of corticosteroids within 6 weeks before selection. 15. Use of medications to lose weight within 3 months prior to selection. 16. Hepatic failure in the selection. 17. Kidney disease or renal failure in the selection. 18. Any abnormality in clinical laboratory tests or ECG, which prevent safe participation in the study. 19. Participation in a study of investigational medication within 90 days prior to selection. 20. Pregnant or lactating woman or women of childbearing age. 21. Alcoholism or drug addiction.

Design outcomes

Primary

Measure	Time frame
Outcome name:Medical evaluation of any adverse gastrointestinal event according to the terms preferred by MedDRA. Being these: Nausea, vomiting, stomach pain and bloating. Measure:GI tolerability of the medication. Timepoints:Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 12.	—

Secondary

Measure	Time frame
Outcome name:Criteria 1-3 and 5-8: Serum levels, after an 8-12 hour fast, of glucose, fructosamine, HbA1c, insulin, proinsulin, peptide C and glucagon. Criterion 4: Function of B cells, which will be calculated mathematically, based on the levels of glucose, insulin, proinsulin and peptide C. Criterion 9: Body weight will be measured on an empty stomach, on a calibrated scale, using light clothing and without shoes. 3 consecutive measurements will be made, to calculate the average. Measure:Efficiency parameters such as: 1) FPG. 2) Fructosamine. 3) AUC of 24 hour blood glucose. 3) HbA1c. 4) B cell function. 5) Insulin fasting. 6) Proinsulin. 7) Peptide C. 8) Glucagon. 9) Body weight. Timepoints:Criterion 1-8: Weeks 1, 5 and 9. Criterion 9: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 12.	—

Measure

Time frame

Outcome name:Criteria 1-3 and 5-8: Serum levels, after an 8-12 hour fast, of glucose, fructosamine, HbA1c, insulin, proinsulin, peptide C and glucagon. Criterion 4: Function of B cells, which will be calculated mathematically, based on the levels of glucose, insulin, proinsulin and peptide C. Criterion 9: Body weight will be measured on an empty stomach, on a calibrated scale, using light clothing and without shoes. 3 consecutive measurements will be made, to calculate the average. Measure:Efficiency parameters such as: 1) FPG. 2) Fructosamine. 3) AUC of 24 hour blood glucose. 3) HbA1c. 4) B cell function. 5) Insulin fasting. 6) Proinsulin. 7) Peptide C. 8) Glucagon. 9) Body weight. Timepoints:Criterion 1-8: Weeks 1, 5 and 9. Criterion 9: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 12.

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Countries

Australia, France, Germany, Mexico, Russian Federation, United States

Outcome results