drugset / Trial / NCT01181674

Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)

NCT01181674 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-01
Primary completion
2015-02
Completion
2015-09

Outcome

Met primary endpoint

paper At 8 weeks, 50.0% of the 8-week intervention group vs 3.6% of controls achieved normoglycemia on therapy PMID 28324049 ↗

paper [relative risk (RR), 14.0; 95% confidence interval (CI), 1.97 to 99.38) PMID 28324049 ↗

paper at 16 weeks, these percentages were 70.4% in the 16-week group and 3.6% in controls (RR, 19.7; 95% CI, 2.83 to 137.13) PMID 28324049 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acarbose Unknown — Oral
Subject Metformin Small molecule — Oral
Subject insulin glargine Protein / enzyme biologic — Subcutaneous