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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Body Weight Changes Body-Weight Trajectory Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Isala

Zwolle, Overijssel, 8000 AB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

individual SUs, insulin, pioglitazone

Drug

Primary outcomes

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

Time frame: Up to 5 years

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.

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.

Time frame: Up to 5 years

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.

Sponsors and collaborators

Lead sponsor

Medical Research Foundation, The Netherlands

Other

Registry information

Official study title

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

Acronym: ZODIAC-39

Important dates

Study start: 1998
Primary completion: 2014
Study completion: 2014
First posted: May 7, 2014
Registry last updated: Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed