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

Medical Research Foundation, The Netherlands16,293 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

16,293

Conditions

Type 2 Diabetes Mellitus

Interventions

individual SUs, insulin, pioglitazoneDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * T2DM * Treated in primary care in period 1998 to 2012 * used metformin monotherapy * subsequently received add-on therapy with a SU or pioglitazone during their entire follow-up period

Locations (1)

Isala

Zwolle, Overijssel, Netherlands

Outcomes

Primary Outcomes

The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy.

The course of the bodyweight up to five years after starting individual SU's (gliclazide/glibenclamide/tolbutamide/glimepiride), pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.

Time frame: Up to 5 years

Secondary Outcomes

The course of the glycaemic control (HbA1c %) , up to five years after starting individual SU's, pioglitazone or insulin as add-on therapy.

The course of the glycaemic control, up to five years after starting individual SU's (gliclazide, glibenclamide, tolbutamide, glimepiride), pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.

Time frame: Up to 5 years

Data from ClinicalTrials.gov

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