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

NCT ID: NCT02133118

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16293 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1998-01-31
• Study Completion Date: 2014-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients on metformin mono-therapy who receive add-on

individual SUs, insulin, pioglitazone

Intervention Type: DRUG

Interventions

individual SUs, insulin, pioglitazone

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Foundation, The Netherlands

OTHER

Sponsor Role: lead

Responsible Party

Gijs Landman

MD, PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

G. W.D. Landman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Isala, Diabetes Centre

R. Wever, MD

Role: PRINCIPAL_INVESTIGATOR

Isala, Diabetes Centre

P. R. van Dijk, MD

Role: PRINCIPAL_INVESTIGATOR

Isala, Diabetes Centre

Nanne Kleefstra, MD PhD

Role: STUDY_DIRECTOR

Diabetes Centre, Isala, Zwolle

Locations

Isala

Zwolle, Overijssel, Netherlands

Countries

Netherlands

Other Identifiers

ZODIAC

Identifier Type: -

Identifier Source: org_study_id