At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes, drug naïve or on submaximal oral monotherapy for <3 years
- ✓Age 18-75 years
- ✓A1C 7.1-10% if drug naïve (after diet/lifestyle failure)
- ✓A1C 7.1-9% if on single therapy (≤10 mg glyburide, ≤4 mg Amaryl, or ≤1000 mg metformin)
- ✕Type 1 diabetes
- ✕Current insulin treatment
- ✕Prior thiazolidinedione (TZD) use within 3 months
- ✕Uncontrolled clinically significant concomitant illness that may limit study participation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin: A 48-week Randomized, Open-label, Multicentre Phase IIIB Study to Compare the Effectiveness of Combination Therapy to Monotherapy in Type 2 Diabetes Mellitus Patients
In Brief
A Phase 3 clinical trial evaluating Avandamet, Avandia and Amaryl, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 391 participants across 1 site.
Detailed Summary
The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
Study Details
Timeline
Interventions
Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily compared to Avandia 4 mg and Amaryl 1 mg once daily over 6 months or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months.
Avandia 4 mg and Amaryl 1 mg once daily compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily, or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months.
Metformin 500 mg twice daily up to 1000 mg over 6 months compared to Avandia 4 mg and Amaryl 1 mg once daily or compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily