Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Insulin Glargine Metformin Acarbose Diet Exercise Lifestyle
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief summary:
The purpose of this pilot trial is to determine whether an intensive treatment with insulin glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.

Detailed description:
This is a pilot trial of 125 patients allocated to either usual care (1/3), 2 months or 4 months of intensive lifestyle and pharmacotherapy followed by cessation of all drug therapy.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: insulin glargine intervention 2: metformin intervention 3: acarbose intervention 4: lifestyle therapy intervention 5: insulin glargine intervention 6: metformin intervention 7: acarbose intervention 8: lifestyle therapy intervention 9: Standard glycemic care
Intervention descriptions: intervention 1: sc injection intervention 2: oral administration intervention 3: oral administration intervention 4: diet and exercise intervention 5: sc injection intervention 6: oral administration intervention 7: oral administration intervention 8: diet and exercise intervention 9: as informed by the current clinical practice guidelines

Protocol document: