NCT02133118

Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.

A Prospective Observational Cohort Study; The Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16,293 (actual)
• Sponsor: Medical Research Foundation, The Netherlands · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Next to HbA1c, body weight is regarded as an important surrogate end-point in trials investigating glucose-lowering agents. An increase in weight could contribute to worsening insulin resistance. Differences in weight after starting glucose lowering agents have been described in many randomized controlled trials (RCTs). With this prospective observational study, weight trajectories after receiving add-on therapy next to metformin are evaluated in primary care patients with good glycaemic control.

Detailed description

This prospective cohort study is part of the ZODIAC (Zwolle Outpatient Diabetes project Integrating Available Care) study, which started in 1998 as a prospective observational study and includes patients with known T2DM who are treated in primary care. The investigators aim to investigate the course of the bodyweight and glycaemic control, the years after starting specific SU's, pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM. As part of the process called benchmarking, a dataset of quality measures is collected annually for all patients participating in the ZODIAC study during the patient's visit to the practice nurse and/or general practitioner and sent to the investigators' diabetes centre for benchmarking and research purposes once a year.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	individual SUs, insulin, pioglitazone

Timeline

• Start date: 1998-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-05-07
• Last updated: 2015-03-17

Locations

1 site across 1 country: Netherlands