Study In People With Type 2 Diabetes

Not Applicable

• Conditions: -E119 Non-insulin-dependent diabetes mellitus, without complications; Non-insulin-dependent diabetes mellitus, without complications; E119

• Registration Number: PER-061-05
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects with T2DM.
2. To be eligible for Randomization in the study, a subject must meet all of the following glycemic criteria: a) HbA1c level via the central laboratory in the pre-selection visit. b) If HbA1c is> 8.0% but <10.0%, the subject can proceed to Randomization. c) If the HbAic> 7.8% but <8.0%, the subject is not eligible. d) • If the HbAic is <7.8%, the subject is not eligible to proceed. e) The level of PPG via the central laboratory at the pre-selection visit should be <270 mg / dL (15.0 mmol / L).
3. Concurrent therapy for T2DM: a) Treated with diet and / or exercises. b) Monotherapy with metformin.
4. Men and women from 18 to 70 years of age.
5. If the patient is female, he is eligible to enter and participate in the present study: a) If he has no potential to have children or b) If he has potential to have children, and has a negative pregnancy test and if he uses acceptable contraceptive methods.
6. Body Mass Index (BMI):> 25 and <40 kg / m2 and weigh at least 50 kg in the Selection.
7. If the subject is a smoker, he should be able to abstain while in the clinic at each visit.
8. Subjects provided full written informed consent before any procedure related to the study was performed.

Exclusion Criteria

1. Metabolic disease.
2. Previous use of insulin for the treatment of hyperglycemia within 3 months of the Selection.
3. History of a recent clinically significant cardiovascular disease.
4. History of chronic pancreatitis.
5. Familial hypercholesterolemia.
6. TGs> 800 mg / dL (8.96 mmol / L) in the Selection.
7. Serum creatinine in the selection> 1.4 mg / dL (124 pmol / L) for women, or> 1.5 mg / dL (133 pmol / L) for men.
8. Clinically significant anemia.
9. History of significant co-morbid diseases.
10. Documented history of hepato-biliary disease.
11. History of metabolic acidosis, rhabdomyolysis, myalgia, myositis or myopathy after taking statins or fibrates.
12. Any subject who withdrew from therapy due to AEs after taking PPARy or a dual PPAR agonist and / or marketed.
13. Signs or symptoms of myositis in the Selection.
14. Who is currently taking or has taken any of the following medications 3 months before the pre-selection visit: a) Anti-obesity agents b) St, John´s Wort c) Warfarin and gold anticoagulants d) Digoxin e) Oral or injectable corticosteroids f) Antidiabetic agents (apart from metformin) g) TZDs 3 months before the pre-selection visit. h) Methotrexate, cyclosporine or monoclonal antibodies i) Atypical antipsychotic drugs j) Antiretroviral drugs k) Lipid reducing agents within 3 months prior to the pre-selection visit. l) Monoamine oxidase inhibitors
15. History of cancer.
16. Women who are breastfeeding, pregnant or who plan to become pregnant.
17. Idiosyncrasy or known immediate or delayed reaction of hypersensitivity to any drug chemically related to the study drug.
18. Known allergy to any of the excipients of the capsule, and history of allergies to the drug or other allergies that contradict participation.
19. Presents a history of abuse of a substance and / or alcohol within the last year.
20. He received treatment with a new molecular entity in the
4 months prior or participated in any other study during the previous 3 months, or has participated in a previous study with GW677954.
21. Likely to not comply with the protocol or scheduled visits.
22. The subject presents any concomitant medical condition that makes it unsuitable for participating in the study.
23. The subject is a close member of the family of a participating researcher, study coordinator, employee of an investigator; or a staff member who conducts the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Glycosylated hemoglobin (HbA1c).<br>Measure:Primary Efficacy: Glycemic control.<br>Timepoints:Day 1 and weeks 4, 6, 8, 12 and 16.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Fasting glucose (FPG). Fructosamine Proportion of subjects who reached target HbA1c levels. Proportion of subjects who reached target levels of FPG.<br>Measure:Secondary Efficacy: Glycemic control.<br>Timepoints:FPG: Day 1 and weeks 1, 2, 4, 5, 8, 12 and 16.<br>HbA1c: Day 1 and weeks 4, 6, 8, 12 and 16.<br>Fructosamine: Day 1 and weeks 2 and 4.<br>;<br>Outcome name:Lipid profile: TC, HDL-C, LDL-C. Tgs, free fatty acids (FFA).<br>Other lipid markers: VLDL-C, apo AI, AII and B.<br>Measure:Secondary Efficacy: Lipid control.<br>Timepoints:Lipid profile: Day 1 and weeks 2, 4, 8, 12 and 16.<br>Other lipid markers: Day 1 and week 16.<br>;<br>Outcome name:Insulin and C-peptide levels:Homeostasis model assessment- insulin sensitivity (HOMA-S) andQuantitative Insulin Sensitivity Check Index (QUICKI).<br>Measure:Pharmacodynamics<br>Timepoints:Day 1 and week 16.<br>